Medicus Pharma (NASDAQ:MDCX) said it has received approval from an Institutional Review Board (IRB) to increase the number of participants in its ongoing Phase 2 clinical trial of a novel non-invasive treatment for basal cell carcinoma (BCC), the most common form of skin cancer.
The company will raise the trial's enrollment target to 90 patients from 60 and expand the study beyond the current nine clinical sites in the United States to additional US locations and two in Europe.
The randomized, double-blind, placebo-controlled study compares two dosing levels of D-MNA with a placebo in patients with BCC of the skin.
Medicus said it has already randomized more than 45 participants and remains on track to submit a briefing package to the US Food and Drug Administration for a Type C meeting before the end of the second quarter of 2025.
“Increasing the number of participants in the study and expanding the clinical trial sites in Europe is very time appropriate,” said CEO Dr Raza Bokhari in a statement.
Bokhari added that the company is also awaiting regulatory approval to launch a separate study in Abu Dhabi and exploring potential collaborations in the Asia-Pacific region.
Interim results from the Phase 2 trial, known as SKNJCT-003, released in March, showed that more than 60% of patients achieved complete clinical clearance. The company’s investigational therapy, D-MNA, was well tolerated at both low (100μg) and high (200μg) doses, with no dose-limiting toxicities or serious adverse events reported.
The 200μg dose was previously tested in Medicus’ Phase 1 study (SKNJCT-001), completed in March 2021, which met its safety and tolerability objectives. Six of the 13 patients enrolled in that study experienced complete response, defined as the histological disappearance of BCC following treatment.
Medicus has also submitted a protocol for a separate Phase 2 study (SKNJCT-004) to the Department of Health in the United Arab Emirates. The proposed trial would enroll 36 patients across four sites, including Cleveland Clinic Abu Dhabi and American Hospital of Dubai.