Medicus Pharma (NASDAQ:MDCX) CEO Raza Bokhari talked with Proactive about the latest expansion of the company's Phase 2 clinical trial for Skinject, its lead noninvasive therapy for basal cell carcinoma.
The company recently received approval from the UK Regulatory Authority to include UK sites in the ongoing Skinject 003 study.
Bokhari explained that this development allows Medicus Pharma to expand its clinical footprint without launching a new trial, as was required in the Middle East.
The expansion brings additional geographical diversity into the pivotal trial without incurring the costs of a separate study.
The Skinject 003 trial initially launched in the summer of 2024 across nine U.S. sites, with a separate 36-patient study underway in the Middle East through Cleveland Clinic Abu Dhabi.
Bokhari also noted that the company has completed a Type-C meeting with the FDA and anticipates a Fast-Track designation following its upcoming end-of-Phase 2 meeting in Q1 2025.
Proactive: All right, welcome back inside our Proactive newsroom. And joining me now is Dr. Raza Bokhari. He is the CEO of Medicus Pharma. And Dr. Bokhari, nice to see you again. How are you?
Raza Bokhari: I'm doing really well. Thank you for having me back on your program.
The company had some news today, talking about getting UK approval to expand your phase 2 trial in dealing with noninvasive treatment of basal cell carcinoma of the skin. Can you remind everyone what’s going on in the UK and what this expansion means?
I really appreciate this opportunity to provide an update. We continue to pick up momentum and move forward in our clinical development program of our lead asset, Skinject, which is a novel, noninvasive treatment for non-melanoma skin diseases, particularly basal cell carcinoma of the skin. We initiated our phase 2 study back in the summer of 2024 at nine sites across the United States in a 90-patient study.
We’ve also been expanding the global footprint of our study. A separate 36-patient study began recruiting earlier this year in the Middle East with Cleveland Clinic Abu Dhabi. Today, we also announced that we now have a nod from the UK Regulatory Authority to expand this study into the United Kingdom. So we are building a global footprint. Basal cell carcinoma is not just an American problem — it's a global problem. Wherever there is ultraviolet radiation and exposed skin surface, that’s a breeding ground. We believe our work is being recognized by regulatory bodies. We’re very bullish that we will have positive findings and will move into a pivotal study.
What does the UK expansion mean? Will that just mean more patients or more sites or both?
It's actually a little more efficient. In the UK, our existing study — the Skinject 003 study — is FDA-approved and being carried out in nine U.S. sites. We can now add at least one UK site to that same 90-patient study, so it's not a separate trial. That makes it a more cost-effective and efficient way to bring in a patient pool from relevant geographic locations, unlike in the Middle East where we had to start a new 36-patient study.
So, as we advance, we’re also becoming more experienced and are running the clinical study in a more efficient and cost-effective manner.
That ability to apply learnings from other markets and do this cost-effectively — that's really important in the development process.
It is indeed very important. We are setting the stage following a Type-C meeting that we completed with the FDA toward the end of Q3. We now have a very clear pathway to registration. We’re also preparing for an end-of-phase-two meeting in Q1 next year, and we’re confident we will qualify for a Fast-Track designation. That meeting will provide clarity on the pivotal design.
Laying this groundwork — in the Middle East, UK, and U.S. — will go a long way in having a robust pivotal study design and executing on it. So this couldn’t be more positive for the future outlook of the company.
Quotes have been lightly edited for clarity and style