Medicus Pharma Identifies 200 µg D-MNA Dose as Lead in Phase 2 SkinJect CSR for Basal Cell Carcinoma

Medicus Pharma's publication of the abridged SKNJCT-003 Clinical Study Report on ClinicalTrials.gov gives QA directors and regulatory leads a transparent, publicly accessible dataset from which to evaluate the company's pivot toward an NDA-enabling development program in Gorlin syndrome, a pivot now anchored to a defined pivotal dose.

The randomized, double-blind, multicenter Phase 2 study enrolled 90 patients across ten U.S. investigative sites, evaluating two dose levels of the SkinJect® dissolving microneedle array (D-MNA) patch against a device-only comparator. All 90 patients completed the study with no discontinuations or withdrawals, yielding a complete dataset for both efficacy and safety analysis. Final analyses were conducted in the modified intent-to-treat population, restricted to patients with centrally confirmed nodular basal cell carcinoma.

The CSR identifies the 200 µg SkinJect® patch as the proposed pivotal dose for forward development. Beyond dose selection, the report formalizes several design parameters that will carry into the next program: a composite complete response endpoint incorporating both clinical and histological clearance, a later primary efficacy assessment window to capture continued response improvement, and a revised comparator selection. These elements are now embedded in the FDA-authorized SKNJCT-005 NDA-enabling program targeting Gorlin syndrome patients with multiple basal cell carcinoma lesions.

For regulatory affairs leads, the structure of this CSR publication is notable. Posting an abridged report to ClinicalTrials.gov ahead of a pivotal program creates a public scientific record that will be referenced during any future 21 CFR Part 312 submissions and pre-NDA interactions. The dataset also serves a parallel commercial function: Medicus has stated it intends to use the Phase 2 evidence package to support partnership discussions for a separate registrational program in nodular BCC, distinct from the Gorlin syndrome pathway.

Chief Medical Officer Dr. Faisal Mehmud noted that the completed study provided the clinical information needed to define dose selection, refine endpoint strategy, and inform assessment timing, learnings the company characterizes as directly transferable to the SKNJCT-005 design.

The SKNJCT-005 program's progress toward NDA-enabling milestones will serve as the next measurable checkpoint for evaluating whether the Phase 2 dataset holds up under the more rigorous demands of a pivotal trial design.

Source: Medicus Pharma Ltd. via GlobeNewswire, September 10, 2026.