Medicus Pharma reports positive Phase 2 data for SkinJect in skin cancer treatment

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 ...