ImmuPharma PLC (LON:IMM) Non-Executive Chairman Tim McCarthy caught up with DirectorsTalk for an exclusive interview to discuss their Phase III Lupuzor trial; why the completion of patient recruitment on track is important, the significance of the 70 patients dosed in the US, safety profile and its importance, the market potential for Lupuzor if approved and their key milestones for 2017/2018
Q1: Tim, ImmuPharma PLC provided an update to the market yesterday to which investors have reacted very positively, how important was it to complete the recruitment of the 200 patients and be on track?
A1: Well, it’s very important, both completing the 200-patient recruitment but also to be on track as well. If I can put it this way, when any company is running a clinical study and you’ve got a target number of patients to recruit it might seem obvious but until you recruit those patients you can’t complete the study. The reason I say that is because it’s not unknown for companies to have problems in recruiting patients i.e. find them, making sure they meet the right criteria to be included in the study and when companies have problems recruiting patients then very often it means that the trial is delayed or it gets more expensive or in extreme cases they can’t even complete the study because they can’t find the patients. So, it’s a very significant moment both for the company, for the trial itself and eventually, hopefully, a benefit to patients.
So, reaching that 200 milestone is significant and the fact that we’re on target, we’ve always said that we’d get that recruitment done by the end of 2016 which we did do, that again is important. As we described in the release yesterday, what we’re trying to send a message out is that everything’s on track, everything’s on time, it’s all looking good so far. So, there’s lots of different messages that went out yesterday in the release but certainly getting the number of patients on time is very important, yes.
Q2: Over 70 patients have been dosed in the US, is this a significant number for ImmuPharma as part of the Phase III trial?
A2: Yes, it is, as we say there’s 200 in total in the study and we’ve recruited patients not only in the US but across a number of countries in mainland Europe and Mauritius. So, if you look at the spread of patients it’s pretty evenly spread, that’s important, not only that we’ve got patients in the US but also that we’ve got a good spread across all the other countries as well. The particular importance of those patients in the US is relevant because that’s where the main drug regulator, FDA or Food and Drug Administration, that’s where they’re based, that’s their territory. The fact that we are operating under their jurisdiction in terms of the study and the approval then it’s important that they can see their own citizens in the US are being treated and that makes them feel a lot happier and in fact, from a regulatory perspective you can’t get approval in the US from the FDA unless you have trialled the drug within their own territory.
So, lots of reasons why it’s important but it is just as important, like I say, that we’ve got a good mix across different countries, different cultures, different ethnic mix. So, I think we’re going to get a really robust result because of that, it’s not all targeted in one particular type of patient or age of patient, it is a real mix and that will give it a really good test within the study and I believe will be very very robust results when we get them.
Q3: Can you give us a little bit more background to your comment in the announcement on Lupuzor’s safety profile?
A3: When anyone’s developing a drug, there are two things that you’re looking for, one is that the drug works and secondly, that it has an acceptable side effect profile. Now, I say acceptable because most, if not all, drugs that are developed and prescribed will have a risk benefit ratio so the benefit is what the patients get from taking the drug, it alleviates their symptoms, it treats them for their ailments, disease, condition, whatever, that’s the benefit they get from it. Essentially, most if not all, drugs are chemicals then putting a chemical into your body will generally create a reaction, what we call adverse events or serious adverse events or side effects, more colloquially termed and it’s that risk benefit ratio that both the developers of drugs and the regulators have to look at to make sure that the benefit outweighs the risk.
Now in Lupuzor’s case, all of the study results we’ve received to date, all the evidence we’ve got about this drug is that it works extremely well and gives relief of symptoms to patients, that it has a completely benign safety profile and what I mean by that is that we have seen no side effects whatsoever, absolutely none. It’s not a question of balancing that risk and benefit, at the moment all we’re seeing is benefit with no side effect profile whatsoever. The reason for putting that in the release yesterday, it’s not that we’re trying to predict the results of this study because we can’t do that, until the study completes which will be in about 12 months’ time we won’t know what the results are because it’s all blinded, nobody knows who’s taking the drug, who’s taking the placebo, but what we can see is there are no serious adverse events that have been reported applicable to the drug. That’s a really important measure, even now at sort of half way through the study, because it’s supporting our premise that Lupuzor will be a very effective drug with no side effect profile. This far into a study, there are 2 patients who have already completed their 12 months and we’ve had over 80% of the patient population in the study have completed at least 3 months so they’ve been exposed to the drug for quite a while, one would expect if there were going to be any adverse events they would’ve started to come out by now. So, it gives us a lot of confidence that the profile is coming together, we obviously won’t know about the efficacy until about a year’s time but it’s really encouraging that we’re not seeing any adverse events at this point.
Q4: So, how important is safety if the drug’s approved for patients and physicians?
A4: Well it is important because this is a really nasty disease and patients are at that point where they really need something that’s going to work for them and at the moment the only thing available is what we call gold standard care which are palliative-type treatments. None of them have been approved simply for the treatment of lupus but they’re given to patients to try and alleviate particular symptoms so for example, a skin rash is one of the symptoms that patients get so they will take a topical skin cream. Unfortunately, as I’ve explained to you before, a lot of these drugs or creams or lotions or whatever they’re using to try and alleviate the symptoms come with side effects so again, it’s not even treating the root cause of the lupus, so patients are getting a raw deal. I should say to balance this, there is a drug that’s been approved for lupus, about 5 years ago, from GlaxoSmithKline called Benlysta and it’s having a certain amount of success, probably not as much as everyone would anticipate, it’s got a certain amount of efficacy but unfortunately it does present with side effects to patients.
So, the importance to us of being able to deliver a drug which is very effective with no side effect profile whatsoever means that those patients can allow themselves to just take Lupuzor and not have to take these other treatments to alleviate their discomfort. So, it’s very important, the safety profile is very important or lack of side effect profile is very important.
Q5: Can you just remind us of the market potential for Lupuzor if it’s approved?
A5: We use a term in the industry called a ‘blockbuster drug’ and what that means is if you’ve got a drug that is selling a minimum of $1 billion per year then it’s termed a blockbuster drug. There are many examples of drugs that sell many billions a year, I think the highest selling drug at the moment is a drug called Humira, for rheumatoid arthritis, probably selling around $13 billion a year so it just shows you the potential of a drug which is effective and treats patients.
When you come back to Lupuzor and the potential in the lupus market you have to look at patient numbers, patient incidents and you have to look at likely pricing of the drug. So across the world we have about 5 million identified lupus patients, if I look at it from a commercial perspective I would generally look at the major pharmaceutical markets so that would be North America, mainland Europe, Japan, probably a couple of other Eastern countries, Asian countries. In those commercial markets there are about 1.5 million identified lupus patients so the way that I usually explain this is those are the patients from a commercial perspective that we can get to more easily, ideally I’d like to get to all of those 5 million patients, give them the treatment and give them relief from their discomfort but from a purely commercial point of view I say if we can access those 1.5 million patients, either we or our partner. The pricing of the drug, I mentioned the Benlysta drug, that’s selling about $35,000 per year per patient, it’s a very high priced drug, so you can see the pricing of something like Lupuzor would allow us to get to that billion-dollar market.
So just simple numbers, even if we priced the drug at $20,000 which is almost half the price of Benlysta and every 50,000 patients we access is $1 billion dollars per year so there’s a lot of 50,000 patient numbers in 1.5 million. The key to this, the absolute key to this, is that we deliver a drug that works. There’s another expression in the industry that we use called ‘unmet medical need’ and what that means is there is a real need from patients for a treatment that works but at the moment is being totally unmet because there isn’t a treatment that these patients can receive that gives efficacy with no side effect profile. So, if ImmuPharma can meet that profile then I’ve no doubt whatsoever this will be a multi-billion dollar selling drug, not $1 billion, multi-billion dollar because simply the logistics and the pricing and the numbers and everything I’ve just explained to you, it will just fly out, absolutely fly out.
Q6: What then are the key milestones for ImmuPharma PLC in 2017 and 2018?
A6: Going forward, obviously, everyone has got their eye on the study itself and we announced yesterday that we should get those results in the first quarter of 2018, in between now and then we will be updating the market, much as we did yesterday, so I guess just reassuring the market more than anything that we’re on track and that everything is looking good.
In addition, what we’ve been trying to do recently is try and raise the profile of some of the drugs in the earlier stage of development which the company has, these are drugs at pre-clinical Phase I, we’ve got a cancer drug ready to go into Phase II. I think because, and I understand why, everyone is focussed on Lupuzor and that late-stage study those earlier stage drugs don’t get an awful lot of attention so we’ve been talking about it at board level and strategic level and we really want to use this next year, 2 years, to bring those drugs on and raise the profile and makes sure that everybody understands that we do have a much wider portfolio than just Lupuzor. So, I would expect that they’ll be some news flow on those earlier stage projects as well.
Listen, it’s a really exciting time for ImmuPharma, really exciting. We’re sat here as a relatively small company on AIM with a potential blockbuster drug which we own 100% of right now and we’re going to get these really exciting results within a year and that’s exciting. I’m even more excited for the patients because we talk to a lot of the patient groups obviously and we talk to a lot of the physicians that have to try and treat these patients and it’s just an awful disease and if we can do something to help these patients then I’d be the happiest man I the world, I really would.
