PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) selected the 200-mcg dose of its SkinJect patch for further development after completing a Phase 2 basal cell carcinoma study, supporting the company’s shift toward an FDA-authorized registrational program in patients with Gorlin syndrome.
The company published an abridged final clinical study report for SKNJCT-003 on ClinicalTrials.gov, providing efficacy, safety, drug-delivery and other findings from the completed study.
The randomized, double-blind Phase 2 trial enrolled 90 patients at 10 U.S. sites and compared two SkinJect dose levels with a device-only microneedle comparator. All enrolled patients completed the study without treatment discontinuations or withdrawals.
Final efficacy analyses used a modified intent-to-treat population consisting of patients with centrally confirmed nodular basal cell carcinoma.
The study led Medicus to select the 200-mcg SkinJect patch as its proposed pivotal dose and to adopt a composite complete-response endpoint incorporating both clinical and histological clearance.
Medicus also plans to use a later primary efficacy assessment after observing continued improvement in treatment response with longer follow-up. Future study design calls for replacing the device-only comparator with a non-penetrating sham intended to better isolate SkinJect’s pharmacologic effect.
The company is planning a randomized, double-blind, sham-controlled registrational study with a statistical design providing about 90% power to detect what it considers a clinically meaningful treatment difference. Medicus said the design is also intended to support discussions with the FDA about a potential single pivotal study approach.
“The completed Phase 2 study has provided the clinical information needed to define the next stage of development, including selection of the 200-mcg dose, continued improvement in clinical and histological clearance with longer follow-up, a favorable safety profile and important learnings around study design and assessment timing,” Chief Medical Officer Faisal Mehmud said.
Medicus is applying those findings to SKNJCT-005, its NDA-enabling Phase 2b study of the 200-mcg SkinJect patch in patients with Gorlin syndrome who have multiple basal cell carcinomas. The FDA has issued a “Study May Proceed” letter authorizing initiation of the study, which is designed to enroll up to about 50 patients.
Gorlin syndrome is a rare inherited disorder in which patients can develop numerous basal cell carcinoma lesions during their lifetimes, often requiring repeated procedures. Medicus estimates about 11,000 U.S. patients with Gorlin syndrome have active basal cell carcinoma, accounting for approximately 50,000 related procedures annually.
The company has applied to the FDA for Orphan Drug Designation and Rare Pediatric Disease designation. If granted and applicable requirements are met, those designations could provide regulatory and economic benefits, including potential eligibility for a Rare Pediatric Disease Priority Review Voucher.
Medicus is concentrating its own SkinJect development on Gorlin syndrome while seeking potential partners to advance the treatment for the broader nodular basal cell carcinoma market.
A company-commissioned 2026 commercial assessment based on physician and payer interviews modeled net pricing of about $25,800 per treatment, an implied U.S. total addressable market of approximately $1.1 billion and potential peak U.S. revenue of roughly $383 million.
Those estimates are not risk-adjusted and depend on successful clinical development, regulatory approval, reimbursement and commercial adoption.
Medicus has also submitted the complete Phase 2 dataset for potential presentation at an international scientific congress and publication in a peer-reviewed medical journal. The company said acceptance for either has not been assured.
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