Hello everyone and welcome to the UK's biggest lunch and learn. My name is Kate Scott Olao from MSD Animal Health, and I have the pleasure of hosting you all today. This isn't just another lunch and learn, today you're part of something special.
Together, we're aiming to make Guinness World Record history by hosting the biggest virtual lunch and learn, while also launching a very exciting new product to the veterinary market. Whatever practise you're in, you're already likely to know MSD for a variety of market leading product ranges. Novivac for vaccines, Revecto for parasite protection, and caninsulin in diabetes.
But today we're excited about something new. We're launching new MelV into the dermatology space. Numelvi is the 1st and only 2nd generation J JAK inhibitor, selective for the relief of canine itch and inflammation.
Over the next hour, you'll hear from renowned veterinary dermatology experts, Doctor Steven Shaw and Doctor Sue Patterson, alongside Doctor Nicole De Rosa, one of MSD Animal Health's veterinary advisors. They will all bring to life how Malvi will support you to simplify canine itch management. Not just in theory, but in the reality of everyday practise.
We know that when a pet owner brings their itchy dog into practise, what they really want is relief for their dog. They want their happy, playful, sleepy dog back. And they want you to help with this quickly, simply, safely and effectively.
Uelvi has been developed with that exact goal in mind. Using 2nd generation selectivity to make itchy dog management simple and effective for you, the vets, the owners, and the dogs. So whether you're here out of curiosity, clinical interest, or to see how Numelvi could work for you and your patients, we're delighted you've joined us for what promises to be an engaging and practical session.
Please post any questions you have in the chat and we'll come to these in the Q&A section at the end. To begin our first session, I'm excited to introduce you to Doctor Stephen Shaw. Steve is one of the UK's most renowned veterinary dermatology experts and is going to take us through an introduction to to Jack selectivity.
Over to you, Steve. Right, well, welcome everybody and we're going to just very briefly look at Jack's selectivity. So before we do that, let's think about the disease that we're treating, so in allergy, infecting the skin and in canine atopic dermatitis.
We see both itch and inflammation, so itch and redness, and cytokines are these immunological messengers that are driving these clinical signs. And they explain very nicely our whole concept of atopy, so cytokines determine both B cell production of IgE, T cell production of pyritigens, and they change the barrier function of the skin and consequently allow secondary infections, so you can see how they have this absolutely pivotal role in the disease. The ones we're most interested in are interleukin 2, interleukin 46, 13, and 31, and.
Most of these belong to a family which we call TH2-like cytokines, and these are the ones that are implicated in AP and the ones that we want to target. But we need to just briefly consider cytokines in their broader context. So cytokine messaging is an essential part of the whole body system.
They're involved in health, disease, they're involved in development of cell lines such as neutrophils or macrophages, red cells, and the initiation and reduction of immune responses. So we've got on a given cell, many tens of thousands of receptors and the way that that cell is going to respond is determined by the specificity of those receptors. So cytokines hit a receptor, it's a two-part receptor, and the way that that message is translated into the cell is by an enzyme at the bottom of the receptor called a JAC.
And this these enzymes are described in four ways, JAK1, JAK2, JAGK 3, tyrosine kinase, or TIC2. And these are the ones that determine the subsequent response. So using a cartoon we'll just try and make that a little bit more real.
You can see here we've got the inside of the cell there in pink, the cell membrane in blue, and across this membrane our cytokine receptor. There's a free cytokine approaching the relevant receptor. And as soon as it's bound, what's gonna happen is the jacks are going to undergo a conformational change.
They're gonna become activated through phosphorylation and they're going to pass that activation on to a secondary molecule called stat. The stamp molecules tend to pair up, and in fact they always pair up, and they are then entering the nucleus, interacting with DNA and we're going to get the message that is required by that cytokine. So that message might be for our diseases, things like inflammation.
H But it also along across the whole panoply of these cytokines, things like hemopoiesis and cell activation. A huge number of different ways that this rather sophisticated mechanism can turn things on and off in the body. So how do we understand how an individual cytokine is going to operate?
So the cytokines we're interested in disease, things like IL 31, in pyritis, or IL-2, 46, 13 in inflammation and in propagation of the allergic response. These are very dependent on the JAK1 enzyme that's at the bottom of the cytokine receptor for those cytokines. There's also JACK-3 and TIIC2 involvement.
By contrast, if we look at the receptors for erythropoietin or GCSF or GM-CSF, so things that are very much involved with the activation and proliferation of cells and red cells, then it's JAK2 that is the predominant driver, in that case with some TI 2 as well. So there's quite a clear demarcation between the two sides. So if we're thinking about what we want from a JAK inhibitor.
We want JAG1 to be inhibited because that's what's in excess and causing our disease. We want to stop the itch, we want to stop the inflammation, we want to make our dog comfortable and a happy, and you know, a happy dog. And that's gonna come via Jack 1 inhibition.
But at the same time, because of the potential for adverse side effects, we don't want Jack 2 to be stimulated. Or sorry, by blocked, pardon me, and. If you look at this lovely Venn diagram, it shows how JAK1 really stays separate from those other, JAK receptors.
So JA one is the one we must target. So Novelly is selective for the JAC1H pathway, that's where we're aiming to block this very specific TH2 like response and get the clinical result we want. And because it is more selective for Jack one.
We get some real advantages which are use from 6 months of age, no recommendation for routine haematology or chemistry. And these represent that favourable safety profile of this product. So at the risk of making everyone immunologists, it's TH2 cytokines that are pivotal to allergic inflammation and itch.
And if we're going to stop their action, if we're going to reduce their action so that we can control allergic inflammation, it's JAC one that we want to be hitting. And when thinking about products that can do that, it's Nuvelmi that very specifically targets JA1 with that reduced likelihood of adverse effects. Thank you, Steve, for that fantastic introduction.
Now to build on Steve's talk, I'm delighted to share a presentation from Doctor Sue Patterson. Sue is also a renowned dermatology expert and will take us one step further, talking about a practical approach to pruritic skin disease and why Jack's selectivity matters in day to day practise. Hi everybody, it's lovely to be with you here today to share this in this very special event.
And following on from what Steve's been talking about, I just wanna talk about how we can use very selective medication to help control many of the very pruritic animals that we actually see. Prurritis is a welfare issue, and it's really important as veterinary surgeons, I feel very strongly about this, that we should control pruritus. We should make dogs very comfortable.
One of the great things about J JACK inhibitors is that they do do that really quickly and really effectively. And so I think there's nothing wrong with using symptomatic treatment. For an animal when it comes in to see you.
But of course symptomatic treatment should not be a long-term solution without actually identifying why that dog is pruritic, and I do think we have an obligation to do some investigation with the animals that we see rather than just giving them a lifetime of medication. We need to know why we're giving them medication. And so an approach to a pruritic dog is not difficult, it's not something that, you know, we need a dermatologist to actually do, this is something that's well within the remit of a primary care practitioner.
Granted, you do need to have the luxury of a little bit of time to do it, so you know, if you don't have the time to take a good history, whether that's a medical history or a dermatological history, you can always get that animal back at another time to give you the advantage of actually doing that. But taking a history gives you an enormous amount of information, you know, is, has this dog got an acute onset? Is there ectoparasitic control in place?
Little nuggets of information that can really help. Doing our examination also helps as well. Doing a general examination because many of the animals that we see sadly don't fit into the textbook.
Many of them have comorbidities, and where they have comorbidities, it can make it more challenging to select therapy, and it can make it much more important that we're looking for a much more narrow focused form of control of pruritus. Rather than a broader spectrum control, once we've done our history taking, once we've done our examination, it allows us to formulate a list of differential diagnosis, and then we can go into either of two ways. It may well be at that stage that we want to do some further investigation, some skin scrapings.
We may want to think about some cytology, looking for infection, or it may be that we want. Perhaps to look at some empirical therapy, which I think is a perfectly acceptable contextualised approach in these cases, potentially by putting empirical treatment in for ectoparasiticides with one of the very many excellent isoxazolines that we have, we may want to think about some topical treatment, perhaps with a chlorhexidine-based product, but what that allows us to do is that allows us to make a diagnosis that we're actually looking at. An allergic dog, and I think we can then justify then going on and looking at some further treatment.
And, of course, we're now completely spoilt for choice when it comes to therapy in allergic animals. We have 5 drugs that I would consider to be my foundation therapies when I'm looking at selecting treatment for an animal, which I know has got canine atopic dermatitis. They're listed here for you on the on the screen, and everyone has its place, you know, particularly when we're looking at comorbidities, particularly when we're looking, for example, at breed differences, you know, I would never, for example, give a Labrador a steroid, but there are some animals that do really well on low dose alternate dose steroids.
But without a shadow of a doubt, the drug that we use most frequently now, and the drug that's got a big. Evidence base to support its use is our Jakinase inhibitors. The problem is, though, and is it, or is it a problem, we have got so much choice when it comes to using R JAK inhibitors.
And with that choice, we have the opportunity to be even more specific in looking at the qualities that each of those JAKs has got that we can then harness to treat our animal. And Steve's talked about narrow spectrum of activity, and certainly in many of the cases that we see in practise, a drug like Neumalvi, which has got this very narrow spectrum of action, is going to be really good, particularly when we get some of these cases that are not straightforward. You know, we look at our average West Highland White Terrier, and the average West Highland white terrier has probably got several of the diseases from the textbook.
Many of them, of course, have got allergies, but superimposed on that, often they have. Second reinfection with anaesthesia. Often they have secondary bacterial infection, and often they have either a previous history of dermatocosis, if you're looking at an animal that's a little bit older, or if they're a young animal, they've actually got dermatocosis there in combination with its allergy.
So using a focused drug, using a narrow spectrum drug that just targets that animal's pruritus, and actually won't make anything else worse, is for me, something that's a really useful drug to have in my armoury. And the dog on the left hand side is a dog that's got all of them. It's got infection, it's got Demadex, it's got an allergy.
And this was given a broad spectrum drug. It was given a steroid, which helped its allergy, but actually, unfortunately, made its infection and its Demodex worse. And if I'd had this dog presenting to me as a youngster, at 6 months of age with an allergy, I could have given it something like Neumalvi with a huge amount of confidence, knowing it would treat the allergy, but it wouldn't actually exacerbate anything else that's going on.
And it's exactly the same with the dog on the right hand side, the dog that has malashesia superimposed on its allergy. Again, I can treat its allergy with a narrow spectrum medication and not make its infection worse. So for me, having the advantage now of a drug that targets specifically that JAC-1, a receptor that's highly specific in its mode of action, that is going to produce a rapid relief for that animal's pruritus, but not make anything worse, I think is such a useful drug for us to use going forward to improve animal welfare and help try and treat these very severely pruritic animals that we see so very often.
Great, thank you very much to Sue for those real life examples of why Jack's JAC one selectivity is so important. Now that we've explored the science and practical considerations behind JAK inhibition and selectivity, it's now time to talk about new Melby. So, I'm pleased to hand over to Nicole, MSD's lead veterinary advisor on Numalvi, who will introduce, introduce us to the product, as well as share some of the dogs who have already experienced great results in Europe.
Great. Thank you very much, Kate. Just So, I just wanted to thank er Sue and Steve again for their exceptional explanations as to why selectivity matters and actually in turn why it should matter to you as first opinion vets and practitioners when prescribing responsibly and making sure that you are choosing the right product for the patient in front of you.
Now, some of you may have seen this slide before, in the field, however, I'm hoping now that this will resonate more heavily with you. Now, Numelvi is the only 2nd generation JAK inhibitor for dogs, and it is at least 10 times more selective for JAK 1 over the other JAK enzymes. And our SPC specifically states that tinvacitinib, which is the active ingredient in Numelvi, Is at least 10 times more selective for Jack 1 over the other Jack family members, and as Steve mentioned, that's Jack 2, Jack 3, and Tyrosine Kinney or tick 2.
Thus, it has very little to no impact on the cytokines that are involved in hematopoiesis, and also in host defence that are dependent on JAK2 and the other JAK family members. So, this in turn gives us this really favourable safety profile and some of the key benefits of Numelvi as a product. And these are the fact that Numelvi is the only licenced JAK inhibitor for dogs as young as 6 months of age.
And this is huge, as a first opinion vet, I think about these cases I saw, but actually from our listenings in the field and also from our key opinion leaders, we know that these itchy dog cases are getting younger and younger, which could be due to the fact that, let's be honest, the breed distribution in the UK is changing, and it probably has been changing for the past 10 years or so. But there may also be other factors at play as well, environmental factors, etc. That could be causing this.
So what this does is it gives our first opinion vets the ability to essentially prescribe a licenced JJAK inhibitor for those dogs from 6 months of age, where you feel that a JAK inhibitor is the appropriate drug of choice. Now, another key benefit of the product is the fact that there is no recommendation for routine or ongoing blood testing. And this is undoubtedly linked to the fact that we have minimal to no impact on JAK2 because we are a highly selective JACK-1 inhibitor.
Now, another benefit of this safety profile of Neumelva is the fact that we can use it concurrently with our vaccines, including the rabies vaccine and also with commonly used veterinary medicinal treatments, such as your ectoparasiticides. And with regards to those vaccines, there were no impact on the protective antibody titers against canine distemper virus, canine parvovirus, CV2, or rabies, and there, this was actually when Numelva was dosed at 3 times the recommended treatment dose. And this is all fine and dandy, right, but we need to know that the product works.
So Numelvi starts relieving itch within 2 to 4 hours and it's simple with effective once daily dose from day 1. Now, as I said, this keeps the dosing nice and simple, also cost effective for owners as they're not having to pay for loading doses of the product, but it also tries to keep that regime as simple as possible, which in turn should hopefully improve owner adherence as they're not having to remember to give tablets multiple times a day. The other benefit that we have without a, a loading dose is we don't see owners trying to return to loading doses when they think that their pet is having a flare up, without any sort of veterinary conversation or consultation with their vets.
And in turn we will also then not see the rebound itch as we are starting on a once daily dose from day one. And on this slide here, we have the dosing chart for Nelva. And as you can see, the dose range is 0.8 to 1.2 mgs per kg per day.
And for me, the best part about this, that makes an average dose of 1 milligramme per kilogramme. So as a first opinion vet, we like to remember nice simple doses, 1 mg per kg for Nelfi. Now, again, another key benefit for me when I think back to my time in practise, is the fact that dogs weighing up to 39.5 kgs require one or half a tablet once daily.
And yes, the once daily dosing is great, but actually with regards to the number of tablets having to be given to these larger dogs, a lot of the time owners struggle to give numerous tablets. So this is a huge benefit, and I keep thinking of those itchy Labradors, itchy golden retrievers. It's just a bit of a no-brainer.
The tablets themselves are unflavored, there's no additional flavourings in there, so they are able to be given to dogs with food allergies. They're also scored, as you can see here on the pictures of the tablets on the screen, which makes it really easy, they're easily split in half for those animals requiring half or, 1.5 tablets, for example.
Now, we haven't run a specific palatability study. However, in our pre-clinical trial work, our clinical trial work, which includes field studies that had client owned dogs in them, there were no reports of any issues with tablet acceptance. And it is also worth noting that numelva is to be given at or around the time of feeding, so either around the time of giving food or with food, as this increases the bioavailability of the product.
Dogs that are above the listed weight bands, so you can see here on the dose chart, those dogs above 79 kg are dosed accordingly with a combination of tablets to achieve that target dose of 0.8 to 1.2 mix per kg.
And in addition to this, I do just want to draw your attention to the fact that with the available tablet sizes and strengths, we do not allow for accurate dosing of dogs weighing less than 2 kilogrammes of body weight. So, how does Nelvi's selectivity support itchy dogs? Glad you asked.
So, as previously stated by Sue and Steve in their, sections in Sue's video, Numelvi's selectivity for JAK 1 over those other JAK enzymes, so remember JAK2, JACK 3, and TI 2. Allows for minimal to no impact on the jacks and those cytokines that are involved in hematopoiesis, and also in the immune system, and what that means is that we don't have any recommendation for routine or ongoing blood testing. I like to point out that SPCs are, they are legal documents and they are the summary of product characteristics and therefore what is on them is what we should do our best to adhere to them, but also to advise accordingly as to what is on that specific SPC.
Now, there are going to be differences between the different JJAK inhibitors as to what is on their SPC, and we would recommend that you do take the time to read the different products SPCs. Now, it is the only licenced JAK inhibitor for use in dogs from 6 months of age. And what this means is that this is the only JAK inhibitor that you can use for dogs under 12 months of age, that are over 6 months, which, as I said, from speaking to our key opinion leaders, our first opinion vets.
We know that these dogs are presenting younger and younger, and this is giving you another string to your bow, another option for treating these pets in practise, which is of huge value if you think that a JAK inhibitor is the appropriate drug choice for that dog in front of you. And vets and owners can also have peace of mind, they're not worried about potential effects on the bloods or on the immune system, and therefore, and that's due to that high level of selectivity for Jack one. So that really provides vet and owner peace of mind.
Let's add to this the fact that we can give routine vaccinations, including the rabies vaccination, at the same time, er, with no impact on protective antibody titers or animals' response to vaccination. And even further to this, we can also give routine treatments at the same time as pneumelva. What a relief for vets in practise for trying to keep these cases as simple as possible.
So, just remember, Numelvi starts to work within 2 to 4 hours. And look, we know as vets, we want to see these patients as comfortable as possible, as quickly as possible, and so do our owners, they want to see their pets feeling that itch relief as quickly as they can. We saw a significant reduction in itch from the first dose.
And also we saw a clinically relevant reduction in itch in over 81% of dogs within the first week of treatment with Neumelvi. Now this comes from one of our clinical studies, it was one of our field studies. And just to make you aware, for dogs to be enrolled in this study, they had to have a PVAS score of greater than or equal to 6 out of 10.
And for treatment to be considered successful, they had to have at least a 50% reduction in owner PVAS score and or a greater than 2 centimetre reduction in itch. So, when we launched this product, as Kate said, so I'm the technical lead for this product in the UK, we really wanted to get a good idea as to what the challenges were. So we hosted some, key opinion leader and referral vet roundtable events looking at the challenges that are faced when these cases present to, our referral dermatologists.
But we also wanted to know what the challenges were that were being faced by first opinion vets in practise, as we felt that there was likely to be a significant difference in what those challenges were. So we also hosted our first opinion round table and challenges event as well. And we listened, we heard you.
And one of the key pieces that came back time and time again was that vets really struggle with the workup of these cases. And because of that, we enlisted the help of known key opinion leader and veterinary dermatologist, Doctor Debbie Gow. And what she has done is helped us to create a step by step workup diagram for how to manage these patients, how to essentially reach a diagnosis, and to try and simplify the workup of our itchy dog cases in practise and make it seem less intimidating.
And what this should do is help to empower vets to feel like they are providing the best quality workup, and the best quality care for their patients. Now, I do just want to add, you may not need to do all the steps on this diagram, before you reach the root of the problem, but it's there as a guide to help where we start to struggle with working up our itchy dog cases. And it also helps us to make sure that Neumelvi's actually being used appropriately and that we as vets are being responsible prescribers.
Now further to this, Debbie also very kindly created a step by step food trial diagram, so that vets can feel supported in running food trials in their itchy dog cases. I should say, there is more than one way to skin a cat, but in the case of Numelvi, should we say dog, as it's a licenced product for dogs. But this is just 11 option for how you can run a food trial.
There are many different ways to do it, but it's there to help support you where you feel you may need that, when running a food trial in an itchy dog case. And I hope that this really shows that all of us here at MSD are really invested and dedicated to improving patient workup, patient care, and also appropriate drug use in our client, in our patients by our vets. Now these are available through our print on demand service Chameleon, but also if you do need any help, please do speak to our account managers as well and they will be able to help you.
So let's move on to some cases. I think people probably want to see some examples. And I want to introduce case one, let's call him Max for argument's sake.
He is a 3 year old golden retriever who unfortunately had suffered with itchy skin from roughly the age of 1. He's from Romania, and he was up to date with his Brevecto injection, and otherwise his owners had no real health concerns apart from the fact that he was itchy and they were really struggling. He was having minimal success with treatments, over the years.
So what we can see here, he was still incredibly itchy when he was seen. He had recurrent otitis external shock horror, and in addition, he actually had caused lesions on his feet and secondary areas of alopecia as well due to intense paw licking. And you can see those in the top photos here on the screen.
Now, he was started on Eumelvi for 2 months, alongside concurrent ear treatments and also supportive therapy in the form of shampoo and wipes. He used a combination of both. And I'm hoping you can see here that there was a considerable improvement in his clinical signs, and there was actually remission of the lesions on his feet.
And the plan therefore going forward with Max was to continue him on with his supportive treatment, his new Melvy, as his owners, his vet, and little Max himself were all very happy with his treatment success. We then have case number 2, it's a gorgeous 7-year-old crossbreed who was diagnosed with atopic dermatitis at the age of 4. Now, he was up to date with his ectoparasite treatments, but unfortunately he wasn't seeing any real success with J JAK inhibitors.
He did actually have, some success with a monoclonal antibody. However, he was seeing very short term treatment success, so about 2 weeks before his clinical signs would start to return. So we can see here, he was really itchy, he suffered from redness, he had discoloration of his lip folds as well, and he had hair loss too.
Unlike the previous case, they started him on Neumelva for 2 months alongside making sure he was kept up to date with his ectoparasite treatments and also with supportive therapy in the form of wipes. And thankfully, there was significant improvements in his itch, his redness resolved, he started to have hair regrowth, and again, this in combination with his supportive therapy and also his ectoparasite treatments was essentially kept as the plan for him moving forward. So another great success story.
And finally, we have case number 3, a gorgeous little 5 year old Yorke, who had suffered from chronic itching, really from the age of 2. Again, owners made sure he was up to date with his extraparasite treatments, but he had had really minimal success, with any treatments, before using Nealva. And you can see here it was chronically itchy, he had a red paws, his front legs were red, he had a really red perianal area and also some hyperpigmentation as well.
And amazingly, after just one month of treatments, alongside supportive therapy with some wipes, he, his symptoms had actually resolved with only one small area of redness on one paw. So again, his owners opted to continue him on with treatment with Neelfi. So, I'm hoping that after looking at those clinical cases, you can appreciate the clinical benefits of the product.
And before I hand back over to my colleague Kate, to start the Q&A with myself and Steve, I just wanted to leave you with those key benefits of the product. So as we said, Numelvi is the first and only 2nd generation JACK inhibitor that is licenced for use in dogs in the UK market. And what this means is that it is at least 10 times more selective for JAK1 over those other JAK enzymes.
And by being selective for JAK1, this drives that really key safety profile of the product that allows for the fact that Numelva is the only licenced J JAK inhibitor for use in dogs as young as 6 months of age. It also allows us to have a concurrent use with our vaccines, so if you remember we talked about the vaccine studies, so it means they can have their routine vaccinations, including the rabies vaccine. They also are able to have concurrent routine veterinary treatments, and er in addition, there is no recommendation, you will find no note on the data sheet at all regarding recommendation or requirement for routine or ongoing blood testing.
And that is due to the fact that Nealvi's high level of selectivity means we have little to no impact on those cytokines that are associated with Jack 2 and some of the other Jack family members that are associated with hematopoiesis and also host defence. In addition to this, it starts working quickly, relieving itch within 2 to 4 hours. As we said, we're seeing results after just that first dose.
And in addition, it's a simple once daily dose from day one with dogs up to 39.5 kg, only requiring a half or 1 tablet once daily. And with that, I just want to say thank you very much for listening, and I'm gonna pass over to my colleague Kate.
Great, thanks Nicole. Great to see those dogs from Europe, seeing great results with N Malvi. So we'll now move into our Q&A session, but before I begin, I saw quite a few questions coming through on the Q&A about when N Malvi will be available in the UK.
And I'm very excited to say it is available now in the UK so you can order it through MWI and MVS using the codes on screen. Feel free to take a photo or a screenshot as we go through the questions, and I've already seen today that a lot of deliveries are going out to practises, so hopefully you can get your hands on new Mby very soon. Right, so now for some questions.
So, there were some questions about selectivity. So Steve, in your presentation, you spoke in, in detail about the implications about being selective and non-selective for Jack one, but there are some requests for a high-level summary of why being selective is important. Could you provide us with a short recap, please?
Yes, of course, so the. The action that you want is jack 1, and the action that you don't want is inhibition of the other jack, so jack 23, and tick 2. So, by being selective, you are getting the benefits of a JAK inhibitor without as many disadvantages of a JAK inhibitor.
So I think that puts it simply. Great, thank you, Steve. OK, so, Nicole, is there a washout period when switching from another JAK inhibitor to newalbi?
Yeah, it's a great question, and actually one we've already had a few times. When we talk about the JAK inhibitors as a whole, so when we look at all of those that are available, they all have a very short half-life. And what that means is that if a dog is being dosed with another JAK inhibitor, you can actually use Numelvi the following day at that next dose because of that very short half-life.
So therefore there is no washout period. Great, thank you. OK.
What pack sizes are available? OK, so I can take that one and we have them on the screen here actually, so you can see there's, 8 different packs of Numelvi. We have the 4 different strengths which you saw on the dosing slide with Nicole.
So we have our 4.8 milligramme, 7.2 milligramme, 21.6, and 31.6.
And for each of those four strengths, there are two pack sizes. So we have the 30 tablet pack. And a 90 tablet tackle.
A 90 tablet pack, which is the 3 by 30 that you can see on the screen, so it's 3 blisters of 30 tablets in the 90 pack. So you've essentially got a pack for 1 month of dosing and a pack for 3 months of dosing. Next question.
OK. Steve, is New Maldy suitable for dogs on a food trial? Oh absolutely yes.
So if you're going to do a a food trial, you obviously want a nicely controlled happy dog. So the first thing to do is don't do a food trial without some treatment. And then you want a treatment that doesn't contain any proteins that are going to affect the results of your food trial and Nuvalmi fits that very well.
And just talking a little bit more about that, the . The rapid nature of the drug coming into the system and also leaving the system makes it ideal to have Nouvelny as that 1st 2 to 3 weeks of treatment and then stop and see what you're left with. So yeah, no, Novelny kind of fits, ticks all of the boxes, for a drug to use during a food trial.
Great, thank you. OK. Nicole, one for you.
Can you summarise what trial work is available for pneumaly? Absolutely. So we have a plethora of studies, study wise we've got two published abstracts, and they are looking at, allergic dermatitis and atopic dermatitis in dogs.
They're both carried out over 208. Days. Now, one of the studies has 289 dogs in it, and the other, other study has 61 dogs.
And those two studies are field trials, so they are using client-owned dogs. We also have our vaccine study which we touched upon today. So if you remember, that was the 3 times the recommended dose and looking at those antibody titers for canine distemper virus, canine parvovirus, CAV-2, and also rabies.
And that was carried out over 24 weeks. And then finally we've got our margin of safety study, or some people call it target animal safety study. And that's it's fairly standardised.
We, you've seen them probably for some of our other products that we sell. So that's a 1 times, 3 times and 5 times overdose study, which went on for 6 months. And I just also wanted to highlight, it is worth noting, although, I think product is actually arriving with vets today.
And we've had our licence for a few weeks, remembering that Europe have actually had a licence since last summer, I think it was around July time, and also Ireland have had a licence since September. So we do also have field experience elsewhere. Great, thank you.
No problem. . OK, So there's been a few mention of steroids, so perhaps another one for you, Nicole.
Can you use steroids with pneumalvi? Yes, it is another great question. So if we think about our trial work that we do, because we are assessing itch scores and PVAS scores, we cannot use steroids at the same time as that trial work as it would interfere with their scores, and it's not then a fair representation of the product itself.
So we don't have, it's not a concurrent use. I would just also like to point out it is not contraindicated. However, it would be, so that would mean it would be a vet's risk benefit basis, so it would be the vet's decision.
Whether or not they chose to do that, I would say it would be worth taking into account things like route of administration, is this a systemic steroid, or is this a topical steroid, for example, is this an ear preparation, and really taking that into consideration, if you were really opting to use the product in combination. But actually, I would really like to hear from Steve as to what he thinks regarding the use of the two together, and maybe where you would want to use one over the other or one first. Yeah, so it's, I, I, it's a complicated question, I think.
So I think we'll deal with the easy end of it first, that. Drugs like Nimelvi with topical steroids at flare points is an excellent way of avoiding the larger adverse effects of steroids, you know, straight away. Then thinking about using them together but perhaps not at the same time, there will be dogs that are very red and sore, perhaps, you know, kind of red pillar box type red dogs.
They really need steroids, they need that that really broad approach. But as, as soon as you're coming off your steroids, you can feel happy about using Neveda. You don't need a, a, a washout period.
There needs to be no gap in your therapy, between that. And then I think using the two together, I can see there, there will be places when that would be used, but that would not be a, a routine action, I don't think. I think.
Using them creatively to in different times, but very close together, you're gonna get the desired effect in the vast majority of cases. Whereas using them together, except in a a kind of a cascade type of situation where you may be treating another disease, I, I would, I would caution against but see the possibility. OK, great.
Thank you. Nicole, when you mentioned contraindications before, you reminded me of a question that came through quite a bit in the registration form, which is, what are the contraindications for numal B? Yeah, absolutely.
So the contraindications for numelva are essentially not to use in cases with known hypersensitivity to any of the actives in the product. And that's it, and it's actually a section we are really proud of on our SPC. And I would again just stress remembering that although all of these drugs are JAK inhibitors, there are differences in the SPCs, and it would be advised to, to read those because as I said, we are very proud of our contraindication section on the UK pneumalva data sheet.
OK. And I'm actually going to ask a question that came up a lot last week at our British veterinary dermatology study group. Can JAK inhibitors like NLV be used for treating otitis externa?
Steve, maybe you could help us with that question. Yeah, so, I think in the context of, study group, there there was probably a, a good understanding that otitis externa is not ear infection. It's that primary inflammatory ear disease that precedes infections and perpetuating changes.
And I think where the primary driving cause is allergy, there are gonna be a, a number of cases where it is gonna do the job well. Just as other JAK inhibitors do. But there are a group of ear diseases where you just need local proactive steroid therapy.
So it's about looking at the ear, looking at the amount of perpetuating change that's there, dealing with any perpetuating change, and then deciding whether that. All over atopic therapy that you're getting from your oral JAK inhibitor is going to be enough to control that dog so it doesn't get atotic flares or whether you need to add something else. So the question isn't, do you give otitis dogs a JAK inhibitor, it's what does the dog look like and how suitable is that particular therapy for that dog.
But for, yes, it is going to be helpful in otititus, but it's not a, a tick box type of question. OK. Great.
Thank you, Steve. And then also in the chat, I'm seeing a lot of questions about our lovely goodie packs that we've sent out. I know some of you have received them and some of you will still be waiting.
We received an overwhelming number of requests for our goodie packs, so we're just doing our best to fulfil those as soon as we can, so just be patient while we get those additional orders through and sent out to you. So, I'm gonna leave the Q&A there, we want to finish a bit early because I know everyone has lots of patients to see and things to do, but what a great discussion. If your question hasn't, hasn't been answered, don't worry, we'll look to take some of the most common questions from the registration form and the chat and, put them on our website.
But if you do have a burning question, that can't wait, please get in touch with your MSD account manager. Thank you for coming everybody. Thank you.
So once again, thank you Steve, thank you Nicole, and thanks to Sue, and for all of you for joining us today, we've been absolutely delighted with the overwhelming enthusiasm for Numelvi. As I mentioned, Numelvi is available to order now through MWI and MVS. And we also have a limited time launch offer of buy 6, get 4 free.
So speak to your MSG account manager today to place your order. Here's to itch relief, that never felt so sinful. Thank you everyone and have a great day.
