Medicus Pharma Ltd. Completes Enrolment of Ninety (90) Patients for Phase 2 Clinical Study (SKNJCT-003) to Non-Invasively Treat Basal Cell Carcinoma (BCC) of the Skin

Core Insights - Medicus Pharma Ltd. is advancing its Phase 2 clinical study (SKNJCT-003) for Doxorubicin Microneedle Array (D-MNA) targeting nodular basal cell carcinoma (BCC) and has completed enrollment of 90 patients in the U.S. [1][2][3] - The company anticipates releasing topline results for SKNJCT-003 by the end of Q1 2026 and plans to request an end-of-phase 2 meeting with the FDA in H1 2026 [1][2][3] Clinical Trial Details - The SKNJCT-003 study is a randomized, double-blind, placebo-controlled trial involving 90 subjects with BCC, comparing two dose levels of D-MNA against a placebo [4] - Participants are randomized into three groups: a placebo group, a low-dose group (100μg D-MNA), and a high-dose group (200μg D-MNA) [4] Previous Study Outcomes - The Phase 1 study (SKNJCT-001) demonstrated safety and tolerability, with no serious adverse events and six participants achieving complete responses [6] - An interim analysis in March 2025 showed over 60% clinical clearance among participants, indicating promising efficacy [7] Regulatory Developments - In November 2025, Medicus received full regulatory and ethical approvals in the UK to expand the SKNJCT-003 study [9][24][25] - The FDA provided positive feedback regarding the development of SkinJect, suggesting a potential 505(b)(2) regulatory pathway for D-MNA [7] Strategic Collaborations and Acquisitions - Medicus entered a non-binding MoU with Helix Nanotechnologies to explore co-development of mRNA vaccines [10][17] - The company acquired Antev Limited, which is developing Teverelix, a GnRH antagonist for advanced prostate cancer, enhancing its pipeline [11][18] Patient Advocacy Initiatives - A collaboration with the Gorlin Syndrome Alliance aims to provide expanded access to SkinJect for patients with Gorlin Syndrome, focusing on real-world data collection [13][14][22][23]