Medicus Pharma (NASDAQ:MDCX) has received regulatory approval from the UAE Department of Health to begin a Phase 2 clinical trial evaluating its non-invasive therapy for basal cell carcinoma (BCC) of the skin.
The study, designated SKNJCT-004, will enroll up to 36 patients across four medical centers in the UAE.
The randomized, double-blind, placebo-controlled trial will assess the efficacy of two doses of Medicus’ topical formulation, D-MNA, against a placebo. Patients will be assigned in equal groups to receive either 100μg or 200μg of D-MNA, or placebo.
The 200μg dose was previously tested in the company’s Phase 1 trial (SKNJCT-001), which concluded in March 2021 and met its safety and tolerability goals. No serious adverse events or dose-limiting toxicities were reported, and six of the 13 participants experienced complete histological clearance of their BCC lesions.
The new study in the UAE complements Medicus’ ongoing US-based Phase 2 trial (SKNJCT-003), which began enrolling patients in August 2024. In March this year, the company announced interim results showing more than 60% clinical clearance among patients treated, based on data from over half of the targeted 60 enrollees. The trial was later expanded to include 90 participants and additional sites in Europe.