Medicus Pharma (NASDAQ:MDCX) said a completed Phase 2 study of its SkinJect therapy showed all 90 enrolled patients finished treatment without discontinuations, data the company says will guide its next-stage registrational trial in a rare genetic skin cancer syndrome.
The randomized, double-blind, multicenter trial enrolled patients across 10 US investigative sites, comparing two dose levels of SkinJect against a device-only microneedle comparator.
Efficacy results were based on patients confirmed to have nodular basal cell carcinoma.
The company said the findings support its plan to focus on SKNJCT-005, an FDA-authorized study in Gorlin syndrome patients who develop multiple basal cell carcinoma lesions, while it looks for a partner to help advance SkinJect for nodular basal cell carcinoma more broadly.
Based on the study results, the company settled on a 200 microgram dose of SkinJect going forward and will measure success using both clinical and histological signs of clearance. It also plans to check results later in the treatment timeline, since patients kept improving the longer they were followed. And instead of comparing SkinJect to a device-only treatment, future studies will use a sham comparator, to more clearly show how much of the effect comes from the drug itself.
Dr Faisal Mehmud, Chief Medical Officer of Medicus, called the publication “an important milestone in the development of SkinJect.”
“We believe that 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,” Mehmud said.
“These findings directly informed our FDA-authorized SKNJCT-005 program in Gorlin syndrome and provide a defined development package that we believe can support discussions with potential strategic partners interested in advancing SkinJect in nodular basal cell carcinoma."
The FDA has cleared Medicus to begin SKNJCT-005, a registrational Phase 2b study testing the 200 microgram SkinJect patch in up to 50 Gorlin syndrome patients with multiple basal cell carcinomas.
Medicus estimates approximately 11,000 patients with Gorlin syndrome in the US have active basal cell carcinoma. The company has submitted applications to the FDA for Orphan Drug Designation and Rare Pediatric Disease designation.
A company-commissioned 2026 independent commercial assessment modeled rare-disease-anchored net pricing of approximately $25,800 per treatment, an implied US total addressable market of approximately $1.1 billion, and potential peak US revenue of approximately $383 million.
Medicus has submitted the complete Phase 2 dataset for presentation at a forthcoming international scientific congress and for publication in a peer-reviewed medical journal, though there is no guarantee of acceptance for either.
