RE: Directors Talk interview30 May 2018 10:52
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.