Medicus Pharma (NASDAQ:MDCX) CEO Dr Raza Bokhari talked with Proactive about the company completing patient enrollment in its SkinJect clinical trial.
The company has now enrolled 90 patients across nine sites in the United States as part of its clinical development program for Skinject, a novel, noninvasive treatment for non-melanoma skin diseases, specifically basal cell carcinoma.
Proactive: All right, welcome back inside our Proactive newsroom. And joining me now is Dr Raza Bokhari. He is the CEO of Medicus Pharma. Dr Bokhari, good to see you again. How are you?
Raza Bokhari: I'm really doing well. Always great to see you again, too.
Yeah, I know we've got some news out about your clinical trial on SkinJect. We'll talk about what the key announcement is, but remind everyone a little bit about the trial that's going on and where it's going on.
Yeah. Thank you. At Medicus Pharma, since the fall of 2023, we’ve been working very hard to advance the clinical development program of our lead asset, SkinJect. It’s a novel, noninvasive treatment for non-melanoma skin diseases, especially basal cell carcinoma of the skin, which is the most common cancer.
And so today you're announcing that you have completed enrollment. So this is a pretty exciting milestone for the company, Raza.
It is indeed a substantial step forward that gets us one step closer to bringing this novel asset to market. We sent our design to the FDA at the beginning of 2024 and commenced recruiting patients in August 2024. So, in less than six quarters, we have now completed enrollment of 90 patients in nine sites across the United States. We are now very well positioned to get topline data read sometime in Q1 of next year. We will sync with the FDA in an end-of-phase-two meeting in the first half of next year and finalise the pivotal design. Hopefully, we can continue building momentum in bringing this novel asset to market.
And just so people understand, this microneedle you're talking about and the process — you're, in essence, putting the medication directly into the cancer, right? Maybe you can give us an idea about how this clinical trial is working.
Non-melanoma skin diseases, particularly basal cell carcinoma — with 5 million new cases in the United States and more than 30 million globally — are typically treated through Mohs surgery. That’s a modified surgical procedure that is expensive, painful, and not esthetically pleasing. But it has been the standard for decades.
We have these uniquely designed, better-protected microneedle arrays that originate from Carnegie Mellon and the University of Pittsburgh. Medicus holds the worldwide rights for development and commercialization. We tip-load microdoses of a known chemotherapeutic agent, doxorubicin, into the microneedles and apply them directly at the site of the lesion. This releases the payload, triggers an immunogenic response, and kills the cancer cells.
We saw complete response in our phase one study, which was completed in 2021. We also saw clinical response in our interim analysis announced earlier this year in Q1. So our confidence level couldn’t be higher. We believe we are on the cusp of bringing to market a noninvasive treatment alternative that is cost-effective, esthetically pleasing, and widely accessible.
All right. Just quickly again — topline data, you're hoping sometime in Q1 2026?
Yes, we hope to announce topline data in Q1 of 2026. Hopefully, by that time, we’ll also have an update on the application we filed with the FDA for the Commissioner’s Priority Review Voucher. That would give us a 10–12 month compression in the NDA (new drug application) timeline. We hope to file that NDA in late 2027 or early 2028.
The Priority Review Voucher, the potential Golden Syndrome indication for expanded compassionate use — these are all aligning well for us. We're coming into the new year with high expectations to deliver on the positive momentum we’ve built so far.
Quotes have been lightly edited for style and clarity