Faron Pharmaceuticals Limited (AIM:FARN) CEO Dr Juho Jalkanen talked with Proactive about the latest positive feedback from the US FDA regarding its phase three clinical trial for cancer treatment Bexmarilimab. Dr Jalkanen shared that the US Food & Drug Administration guidance will accelerate its trial, potentially bringing new treatments to the market sooner.
Dr Jalkanen explained: “We went with a humble attitude to the FDA, proposing a phase three trial for relapsed refractory MDS [Myelodysplastic syndrome, a blood-borne cancer]. The big news is that the FDA recommended going directly into a frontline MDS study, opening up a much larger market sooner than anticipated.” This acceleration not only speeds up the process but also targets a larger patient population without significantly increasing trial costs.
Proactive: Juho, nice to speak to you. You've announced what you describe as very positive feedback from the US FDA on the design of the phase three clinical trial for bexmarilimab, so great news.
Juho Jalkanen: Yes, absolutely amazing news I have to say. If I can shed a bit more light on what actually makes it so amazing and positive is that we went because currently, we're in phase two, aiming to have enrollment completed by the end of the year. And we went with a humble attitude to the FDA. So we're going to have phase two done. What should we, start next year? And we went and proposed a phase three in relapsed refractory MDS. And basically they [the FDA] said yes to that trial as well. But the big news for feedback is that given that there's, you know, well-established safety profile with the drug and the encouraging results already seen in both relapsed refractory and frontline MDS, why don't you instead should go directly into our frontline MDS study, which opens up a lot bigger market a lot sooner than we anticipated.
Proactive: So will this accelerate the whole process then Juho?
Juho Jalkanen: Yes, exactly. So this will accelerate, the whole process of getting a label for the entire high-risk population. Within this guidance, people may want to go read it. It's called the front-runner program, where promising new treatments in areas of high unmet need are brought forward more quickly to patients. It also has the possibility for accelerated approval, within it based on response rates. And so it's very much accelerating the entire program on a lot of fronts.
Proactive: This phase three program also targets a larger patient population. So what will it do to the cost for the trial?
Juho Jalkanen: Not necessarily much. This is actually a discussion we had with the FDA. Again, we went with a very humble approach that we're a small biotech in a front-line study, you know, would be quite big and possibly, you know, difficult for a small company for us to do. But instead, the FDA actually responded, with your current results. If they hold up, phase three and the front line won't have to be that big either.
Proactive: Okay. So this increases also your sales forecasts, I presume, for Bexmarilimab and you're adjusting your development plan accordingly.
Dr Juho Jalkanen: We'll have to do some modelling on, the new phase three now set by the FDA and also modelling our commercial forecast accordingly on when we would hit the market and what the patient population is because these are big, significant changes in our projections.
Proactive: In the meantime, you're also then obviously focused on the phase two trials.
Juho Jalkanen: Yes. So that runs according to plan. No changes to that because that would actually then possibly become the approval file for the relapsed refractory population, which would be amazing. So that continues just as planned. But for next year, instead of planning a phase three in relapsed refractory, we're going to start preparing for a phase three in the frontline population.