PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) said it has completed U.S. enrollment for a Phase 2 clinical study testing a needle-free treatment for a common form of skin cancer, a milestone that moves the company closer to regulatory discussions and late-stage development.
The study, known as SKNJCT-003, enrolled 90 patients with nodular basal cell carcinoma and is underway at nine clinical sites across the United States. Medicus said topline results are expected in the first quarter of 2026, followed by an end-of-Phase 2 meeting with the Food and Drug Administration in the first half of the year.
The trial is evaluating the safety and effectiveness of a doxorubicin-containing microneedle array, or D-MNA, designed to deliver localized therapy directly to cancerous skin tissue without surgery. Basal cell carcinoma is the most common form of skin cancer, and Medicus estimates the addressable market at roughly $2 billion.
The randomized, double-blind, placebo-controlled study compares two dose levels of D-MNA against a placebo microneedle array, with patients assigned evenly across the three groups. The higher dose mirrors the maximum level tested in an earlier Phase 1 trial that met its primary safety and tolerability goals.
Medicus has previously reported interim Phase 2 data showing more than 60 percent clinical clearance in an early subset of patients, results the company described as encouraging but preliminary. The full dataset will determine whether those trends hold across the entire study population.
Beyond the U.S. trial, Medicus is expanding the SkinJect program internationally, with a separate Phase 2 study underway in the United Arab Emirates and regulatory approvals secured to extend the current study into the United Kingdom. The company has also received FDA feedback supporting a potential 505(b)(2) regulatory pathway, which can shorten development timelines by relying in part on existing safety data.
Medicus has broadened its pipeline through partnerships and acquisitions, including the purchase of U.K.-based Antev Limited and a collaboration aimed at expanding patient access to its investigational therapy for individuals with rare, recurrent skin cancer syndromes.
For investors, completion of enrollment removes a key execution risk and sets up 2026 as a pivotal year, when clinical results and regulatory guidance could determine whether Medicus’s microneedle platform advances toward commercialization or remains a high-risk development bet.
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