Faron Pharmaceuticals Limited (AIM:LON:) CEO, Dr Juho Jalkanen, talked with Proactive about the significant fast-track designation awarded to their cancer immunotherapy, bexmarilimab, by the UK’s MHRA. The drug is being used to treat people with relapsed refractory Myelodysplastic Syndrome (r/r MDS).
Looking ahead, Jalkanen shared that a confirmatory phase III study is being planned for high-risk MDS patients globally, in collaboration with major regulatory authorities.
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Proactive: You’ve announced that you’ve been given fast-track status for bexmarilimab in the UK. So a significant development for your cancer immunotherapy?
Dr. Juho Jalkanen: Yes, totally. It’s great that the Medicines and Healthcare products Regulatory Agency (MHRA) saw it exactly the same way as did the FDA. So it’s looking very good.
Proactive: At the same time, they’ve also said that the BEXMAB study can proceed in the UK. So really the green light to get going on it here?
Dr. Juho Jalkanen: Yes. And as you may know, the UK is like a second home for us. We’ve always felt very strongly about having this also available for UK patients. Since it’s looking so good, there may be something we could provide for those relapsed refractory Myelodysplastic Syndrome (r/r MDS) patients. So finally, there’s a good trial now ongoing in the UK for these patients, which is amazing.
Proactive: Juho, tell us more about the innovation passports and what it actually allows for you to proceed with?
Dr. Juho Jalkanen: So as you mentioned, it’s like a fast track designation. So we get regulatory support, we can have rolling submissions, more interaction with the MHRA, and possibly early access to the drug before full approval. A lot of good stuff, especially for the patients.
Proactive: Tell (WA:) us a little bit more about the program and what the next steps are now that you have this new fast track designation.
Dr. Juho Jalkanen: Well next, we’re actually going to talk with the MHRA about the Phase 3 study plan. So that’s up next with the MHRA under this program.
Proactive: And what is that Phase 3 study plan? What does it entail, Juho?
Dr. Juho Jalkanen: So it’s like with the FDA. The FDA said for the relapsed refractory population, a Phase 3 wouldn’t be needed, but a confirmatory Phase 3 should be run in the first line of high-risk MDS population. That study plan we’re going to go over with the MHRA to get their input on it as well, because we’re planning a global Phase 3.
Proactive: So you will be conducting the Phase 3 in more than one geography in that case?
Dr. Juho Jalkanen: Yes. Yes, it’s a truly global study.
Proactive: Well, I hope you’ll keep us posted on any additional progress. Thank you very much for speaking with us today.
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