A Conversation About MetrioPharm AG’s Phase II Clinical Trial
MetrioPharm AG has just published Top Line Data for the Phase II clinical trial in psoriasis. Was the study a success?
Wolfgang Brysch: Yes, the study was clearly a success. We had a number of specific questions and were able to answer most of them. More importantly, we are very satisfied with the answers we got. We have demonstrated a disease-modifying effect of MP1032. And we saw a clear dose-response correlation.
Let’s take a look at the results. What went well, what are you not so satisfied with?
Wolfgang Brysch: We randomized 155 patients to be treated over 12 weeks with two different doses of MP1032 or with placebo. At both doses we were able to show an improvement in symptoms that was clearly superior to the placebo arm. However – this is the drawback of these results – we did not achieve statistical significance.
Barry Frankel: We had a number of drop-outs, although none due to treatment related events, and patient numbers were eventually lower than we had hoped for. But, we saw a clear improvement in both dosage groups. I think if the study had gone on longer than 12 weeks, as is the case with other psoriasis studies, we could have achieved statistical significance even with this smaller group of patients. And, overall, the high dosage was superior to the low dosage. That is a solid dose response effect and always a good sign.
Why did you choose psoriasis as the indication for the clinical trial of MP1032?
Barry Frankel: Psoriasis is especially well suited to prove a disease-modifying effect. In other indications the improvement of symptoms could have been due to pain reduction. That would not be bad, but we wanted to show that MP1032 has a more profound effect. The reduced skin lesion in psoriasis means that MP1032 modifies the disease.
Wolfgang Brysch: However, our preclinical results suggest that the mode of action of MP1032 can be even more effective in diseases where oxidative stress is a more central pathomechanism than in psoriasis.
The drug has also been tested for safety. How did the result turn out
Wolfgang Brysch: We had expected a good safety profile. But the actual result of the study is most extraordinary. We had most side effects in the placebo group. In the verum groups, the incidence of side effects was reduced dose-dependently. This effect was even statistically significant: the higher the dose of MP1032, the fewer general side effects – for example headaches, infections or gastrointestinal symptoms – the patients had. This sounds paradoxical. But it fits very well with our assumption that the reduction of cellular oxidative stress has a very broad effect spectrum that goes far beyond individual chronic inflammatory indications.
Barry Frankel: I would even go as far as to say that these safety data serve as a surrogate measure of efficacy. In my entire career, I’ve never seen anything like this in any safety study of any drug.
What do the results of the study mean for patients?
Wolfgang Brysch: After this study, we see many possible applications. For psoriasis patients who are good responders, the results mean that MP1032 can become an effective new therapy option with a superior safety profile. Our preclinical work also shows that there are more promising target indications. MP1032 could, for example, be very well suited for the early, safe treatment of musculoskeletal or neuroinflammatory indications.
Barry Frankel: I believe this is a breakthrough drug. With enough data this will ultimately be viewed as a chronic therapy for patients who reach a certain age as a preventative treatment that is taken every day. Not unlike many older patients take a small dose of Aspirin, but with a much broader effect.
So now that the study is completed, what is next for MetrioPharm AG
Wolfgang Brysch: This study certainly confirms our assumption that MP1032 is a real platform drug. Our goal for the future is clear: we want to make this drug available to as many patients as possible, as soon as possible.