Medicus Pharma Ltd. (NASDAQ: MDCX) maintained its upward momentum in the aftermarket session on Thursday, registering a 14.60% increase to reach $5.18 per share. This surge followed an impressive 11.88% rise during regular trading hours, closing at $4.52. The company’s stock performance was buoyed by significant regulatory progress in the Gulf region, signaling investor confidence in its ongoing clinical developments.
UAE Clinical Trial Expands Medicus’ Research Footprint
In order to evaluate a non-invasive therapy for cutaneous basal cell carcinoma (BCC), Medicus Pharma has formally filed a clinical study proposal (SKNJCT-004) to the Department of Health (DOH) of the United Arab Emirates (UAE).
In all, 36 patients will be enrolled in the trial at four prestigious medical facilities: American Hospital of Dubai (AHD), Sheikh Shakhbout Medical City (SSMC), Cleveland Clinic Abu Dhabi (CCAD), and Burjeel Medical City (BMC). The clinical trial will be coordinated by Insights Research Organization and Solutions (IROS), a UAE-based contract research organization affiliated with M42.
Study Design and Early Findings
The purpose of the SKNJCT-004 trial is to assess the effectiveness of two dose levels of the experimental product D-MNA in a multi-center, randomized, double-blind, placebo-controlled research. One of three groups—a placebo-controlled group receiving P-MNA, a low-dose group (100μg of D-MNA), or a high-dose group (200μg of D-MNA)—will be randomly allocated to each participant.
The main safety and tolerability goals of SKNJCT-001, a previous trial, were well achieved. No major adverse events (SAEs) or dose-limiting toxicities (DLTs) were recorded, and the experimental therapy was well tolerated at all dosage levels. Additionally, six participants experienced a complete response, defined by the histological disappearance of BCC in final excisions.
Regulatory Pathway and Future Developments
For its continuing SKNJCT-003 research, Medicus Pharma is moving closer to an interim data analysis, with results anticipated by the end of Q1 2025. MDCX plans to present these results to the U.S. Food and Drug Administration (FDA) at a Type C meeting.
This meeting may speed up the approval process for its innovative treatment and offer a place for discussing the clinical development strategy. By using this regional expansion to further its search for a first- and best-in-class therapeutic solution, MDCX aims to become a leader in non-invasive cancer therapy.