Medicus Pharma (NASDAQ:MDCX, TSX-V:MDCX) CEO Dr Raza Bokhari talked with Proactive about the company’s ongoing Phase 2 clinical study for its lead asset, SKNJCT.
This novel, noninvasive treatment is designed to deliver doxorubicin directly to basal cell carcinoma lesions.
Dr. Bokhari shared that over 50% of the targeted 60 patients have been randomized in the placebo-controlled trial, which spans nine sites across the United States. He also confirmed that interim data would be available before the end of the quarter.
Proactive: Welcome back inside our Proactive newsroom. Joining me now is Dr Raza Bokhari, CEO of Medicus Pharma. Dr Bokhari, good to see you again. How are you?
Raza Bokhari: Thank you. Always a pleasure to come back on your program.
Good to have you along, especially with your latest update on Medicus Pharma’s Phase 2 clinical study. You’ve now randomized over 50% of the 60 patients targeted. That’s a positive step forward, isn’t it?
Thank you again. Always a pleasure to be on your program. To recap for your viewers, Medicus Pharma’s lead asset is SKNJCT, a novel, noninvasive treatment for basal cell carcinoma, the most common skin cancer.
We took control of this asset in fall 2023 and have moved quickly. We submitted a Phase 2 proof-of-concept study to the FDA to evaluate the clinical efficacy of delivering doxorubicin directly to the lesion. This study involves 60 patients in a double-blind, placebo-controlled trial across nine sites in the US. We have now surpassed the 50% mark for patient enrollment and have reiterated to the market that we will release interim data before the end of this quarter.
How important is this interim readout, particularly in dealing with the FDA?
It is a critical milestone in our clinical program. We believe this novel therapy should receive fast track designation from the FDA. We have prepared a comprehensive package to secure a Type C meeting with the FDA before the end of Q2, where we will present this interim data.
This study builds on our Phase 1 results, where we saw complete responses in patients with nodular basal cell carcinoma. The new data strengthens our confidence in the treatment’s potential and reassures investors that their funds are being utilized effectively.
Additionally, this interim data will support our discussions with the FDA. We aim to secure a fast track designation, expand the trial to a pivotal study involving up to 400 patients, and clarify the regulatory pathway to commercialization, likely through a 505(b)(2) pathway. Our goal is to bring a commercially viable product to market before the end of 2027.
Quotes have been lightly edited for clarity and style