Medicus Pharma seeks FDA alignment on streamlined Phase 2b/3 Teverelix study

we can cut this cost down remarkably uh from what could have been a 100 million spend over next five years down to uh we hope is 25 to 30 million.

Welcome back inside our Proactive News Room and joining me now is Dr. Raz Bakari. He is the CEO of Medicus Pharma. Dr. Bakari, great to see you again. How are you?

I am doing really well, Steve. Thank you so much for having me back on your program.

Yeah, so company on with some pretty significant news at the end of last week. I wanted to get you on to talk about it because it's uh it it's interesting because it deals with something that's uh a real challenge and that's advanced prostate cancer, which we've uh heard about in the past and and the the challenges with it. And now you're looking at using Teverelix in that. So maybe take a step back and remind us about this program.

Yep. So indeed, Steve, uh uh your viewers and uh our uh shareholders have been very supportive over these last three years since we came on the scene and in building our uh portfolio of of companies. uh a little over last year uh around this time, we had completed acquisition of a UK-based company and through their acquisition, we took control of this next generation GNRH antagonist and androgen uh suppressing therapy, an injectable a decapeptide uh that was focused on in men's health into uh indications. Uh one is to prevent relapse of acute urinary retention due to enlarged prostate. And the second indication was a dose optimization study to evaluate Teverelix in patients, in advanced prostate cancer patients with high cardiovascular risk profile. We took uh uh control of this asset as a first step. We uh looked at these designs and wanted to make them more capital efficient and more in line with where in doing these novel therapies, uh when if we have to uh uh see failure, we see that failure uh uh earlier than later.

And in that context, not only very quickly, if I can recap, few uh weeks ago, we had gotten from the FDA a sign-off of a uh optimized study for our program on Teverelix for acute urinary retention. So we inherited a 390 patient study and now we have landed with 126 patient study. So bringing the cost down from over 30 million to somewhere in the neighborhood of 7 and a half million over next three years.

In the same mechanism, we're very uh pleased that last week we submitted a a registrational protocol uh for Teverelix in use for advanced prostate cancer patients with high cardiovascular risk profile. When we had inherited this uh program, we had an approved uh dose optimization study of 40 patients, which had a cost of about 3 million and a framework of about 1500 patients that would have probably cost like 100 million or so. We, our R&D team sat, it looked through and now they have combined the dose optimization study with a seamless registrational protocol of about 600 patients. Effectively, we're making uh have reached out to the FDA that it should let us have the dose optimization become part of a registrational study. So as a gated mechanism. So in a stepwise fashion that we as we progress, all of these patients are counted towards a NDA enabling program.

And also, we can cut this cost down remarkably uh from what could have been a hundred million dollar spend over next five years down to uh we hope is 25 to 30 million. And more importantly before I uh uh before I lose your your patience uh in in this very long answer, also make this partner ready because our interest is to find partners to take the baton off our hand.

Yeah, and and it's an it's an interesting way to go and I know you've submitted to the FDA and looking for them to to sign off on this as well because that's the sort of the next stage of this, but you know, there's nothing to say that that while you're researching something else, as you said, you're adding things together to makes to to move things forward, first of all faster and secondly, more cost efficient. I mean that seems like it's sort of the way of the world we're going right now is to try to do things together in order to save money and move things faster.

Well, that is the from the days of Adam and Eve uh Steve, the the objective is to do things in a time and a cost uh efficient fashion. We live in very interesting times with uh with with artificial intelligence and these uh other sophisticated tools and uh and some very recent uh publication that came in the Journal of American uh Medical Association with respect to uh uh the cardioprotective or plaque formation indications that has given us a a very strong, we believe a very strong scientific basis to uh reach out to the FDA to uh to permit us so we can combine uh uh these programs and marshall our resources in a manner that not only uh that the uh we can reach to a uh potentially a better patient outcome uh sooner, but also at a substantial uh cost uh efficient fashion, and above all, make the program a partner ready for bigger players to who are more uh adept in late stage development, uh to collaborate with us. So this is uh uh uh trying to do uh uh in a in an orderly fashion, a complicated work, uh but hopefully in a with seamless and good outcomes.

Okay. All right, well, we'll have to see what the FDA says on that. Uh it really is interesting and a and a really good way to go. It sounds like uh in order to get to to where you want to go much quicker and obviously with capital intensive uh keeping that low as well. So Dr. Bakari, thank you. Good update. Good to see you as well. We'll talk soon, okay?

Always a pleasure Steve and thank you so much and my apologies for a little uh protracted and long uh long response to your question.

It's a good way to, you got to keep it up to date. Make sure everyone understands what we're talking about. So thank you, Dr. Bakari. Uh CEO here of Medicus Pharma.