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ImmuPharma PLC Q&A: Topline Results of Lupuzor Phase III Trial

ImmuPharma PLC (LON:IMM) Chairman Tim McCarthy caught up with DirectorsTalk for an exclusive interview to discuss the topline results of their Lupuzor Phase III trial


Q1: Tim, we saw the announcement of your topline results in the Lupuzor Phase III trial this morning, can you give us an overall perspective on the data?

A1: The data issued this morning was the topline results of ImmuPharma’s Phase III study of Lupuzor for the treatment of lupus.

What we reported was that we saw superior efficacy in the Lupuzor group of patients versus the placebo group of patients in quite a number of different measures, unfortunately, we didn’t meet the primary end point and that is to reach statistical significance. If I can just explain what that means, it means that if you have the advantage of a drug over placebo, the size of that advantage, between the response that you get in the active drug versus placebo group has to be a certain amount which when the statisticians work out the numbers, you get statistical significance. That’s a pretty widely used measure in our industry in terms of clinical studies.

So, unfortunately, we didn’t see that statistical significance, so we didn’t meet the primary end point. However, the data that we did get from the study was extremely encouraging and in every measure that we look at, the active group with Lupuzor was superior to placebo so that is really big advantage.

Just as importantly, we have a very very good safety profile and what I’ve always said when explaining Lupuzor to anybody, it’s all about the product profile. So, the product profile of any drug is how efficacious it is, how well it works on the patients and what the side effect profile is if there is one.

So, despite the fact that we missed the primary end point, we do have a good drug here and it’s clear it works, we’ve got some good efficacious data and absolutely no side effects at all which we were expecting but to have it confirmed in a Phase III study is excellent. So, that overall is what we presented this morning.


Q2: How confident are you now then on the overall safety and efficacy of Lupuzor?

A2: I’m extremely confident because you can’t deny, in the same way we can’t deny that we didn’t reach statistical end point, you can’t deny the fact that we got very good efficacy with the drug. On the safety profile, we’ve seen that before in previous studies and we weren’t expecting to see anything on the safety side but it’s always pleasing to get that confirmed in a larger study which we have with this Phase III.

So, what you’ve got effectively, if we step aside from the result of this particular study, what you’ve got is confirmation with this Phase III that we have an efficacious drug with an absolute benign side effect profile.


Q3: So, what are the next steps regarding partnering solutions?

A3: We put a little piece in the release today, just to say that we have had a lot of interest from larger pharmaceutical companies in the Lupuzor programme and all of those are potential partners were waiting for the data, like everybody else. So, we’ll be reaching out to them in the next few weeks and months and sharing the data with them and we’ll see where we get to with those discussions but there was very strong interest from a number of pharma partners.

I would remind your listeners once more, to step back from the disappointment of the result today in terms of the statistical significance, what it has confirmed today is we have an efficacious drug with a complete benign side effect profile. If I was a lupus patient searching around for treatment, I would say to my doctor ‘please, I would like to take Lupuzor because it’s clearly efficacious, it’s going to benefit me and I’m in no danger at all from any sort of side effect profile’. So, that’s a powerful profile and I think it will be an attractive proposition to a number of pharma companies.


Q4: Will ImmuPharma now look at investing in your pipeline, outside of Lupuzor?

A4: It’s an interesting question because clearly the focus on the company for the last 2-3 years, for obvious reasons, has been on Lupuzor and the Phase III study but we have tried to remind investors whenever we can that we do have other products in our portfolio. Primarily, we’ve got an oncology programme, a cancer product, which is ready to enter into Phase II with some very good pre-clinical Phase I data and we also have some pre-clinical work going on in the area of diabetes, in a specialist area of diabetes called NASH.

So, yes, we will be looking at those now to see if we can bring those forward, but we shouldn’t forget Lupuzor and I do want to emphasise the fact that Lupuzor is still there and we’ll continue to push it forward primarily through discussions with pharma partners. As far as I’m concerned, we still have an extremely attractive drug, Lupuzor.


Q5: Can you provide guidance on your current cash position?

A5: Yes, we’re very strong actually on the cash position. We raised $10 million earlier this year, we already had cash in the bank and the previous guidance was that we had enough cash to the of 2018 before we raised that £10 million. Of course, what your listeners should understand is that now the Phase III study is completed, all the cost have that are now done so if one was to look at our expenditure over the last couple of years then you will see that expenditure come down quite dramatically going forward because we haven’t’ got the costs of the Phase III study.

So, I can’t be exact on it in terms of cash flow and outlook, but we’ve certainly got at least 2 years, if not 3 years of money in the bank so we’re in a really strong position.

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