What Are the Next Steps for Ridinilazole?

Dr. Richard Vickers, chief scientific officer of R&D at Summit Therapeutics, discusses what the next steps are for Summit Therapeutic’s ridinilazole.

Interview Transcript (modified slightly for readability):

“Having come out of our phase 2 clinical trial, our proof-of-concept study, we have really strong data that indicates a significant improvement in sustained clinical response with ridinilazole compared with vancomycin. The next stage is to move into phase 3 clinical trials.

We’ve established early proof-of-concept, but we need to go into a much larger patient population; in total, it would be 1400 patients in the phase 3 studies. Following these phase 3 studies, should we meet our endpoint, the next stage will be to try and get approval of the drug. And in these studies, again, we’re looking to use sustained clinical responses as our primary endpoint. We really want to demonstrate that we have a significant improvement over vancomycin, our current standard of care on sustained clinical response. And this endpoint is just so important as it tells you you’ve treated the initial infection and have not had a recurrence.

Really, we’re going to try and replicate what we did in the phase 2, and, traditionally in antibiotic studies, there tends to be a strong translation from stage-to-stage-to-stage. Based on the data we’ve generated to date, and the robustness of the scientific package, I think we have reasonable confidence going into these phase 3 trials, that we should get close to replicating what we did in phase 2.

It’s a very exciting time for Summit Therapeutics. We know that the antibiotic pipeline is generally pretty thin and we know that funding has been pretty difficult to secure, and as a really small biotechnology company, what we’ve been able to do over the last year or so, is secure a contract with Barda, which is a US government department providing up to $63 million in funding to help us get into phase 3 clinical trials. And so, it’s actually a very exciting time for Summit, and I’m very much looking forward to getting back into patients, and who knows, getting approval of the drug in a few years’ time.”