(RTTNews) – Medicus Pharma Inc. (MDCX), a biotech/life sciences company, on Tuesday announced the receipt of a ‘Study May Proceed’ notification from the U.S. Food and Drug Administration (FDA), allowing for the initiation of the Phase 2b SKNJCT-005 trial evaluating SkinJect in Gorlin syndrome.
The FDA reportedly dispatched the authorization after completing a safety review of the company’s investigational new drug (IND) application for SkinJect.
SkinJect constitutes a dissolvable microneedle-array patch delivering doxorubicin, a chemotherapeutic drug, directly into basal cell carcinoma lesions to enable localized treatment while minimizing systemic drug exposure.
Previous Phase 1 and Phase 2 studies evaluating the therapy showed promising lesion clearance. The SKNJCT-003 study conducted on 90 patients demonstrated a 64% clinical clearance and a 55% histological clearance following three doses of 200 mcg SkinJect over 57 days.
The Phase 2b SKNJCT-005 trial is an open-label, multicenter, registrational study to enable a new drug application (NDA) for SkinJect. The trial expects to enroll up to 50 patients with Nevoid basal cell carcinoma, also known as Gorlin syndrome.
Gorlin syndrome is a rare autosomal dominant genetic disorder caused by mutations affecting the Hedgehog signaling pathway, characterized by the lifelong development of multiple basal cell carcinomas beginning during childhood or early adulthood. Many patients develop dozens of tumors through their lifetime, requiring repeated surgical excisions that can result in cumulative scarring and a psychosocial burden. The condition affects approximately 1 in 30,000-60,000 individuals worldwide.
The ‘Study May Proceed’ letter issued by the FDA on July 23, 2026, was accompanied by certain terms for Medicus. The conditions required specific protocol amendments to the SKNJCT-005 study.
These include a baseline biopsy confirmation of carcinoma in enrolled patients, an in-person investigator’s assessment of histological clearance, and an extension of patient follow-up for 24 weeks, or up to two years in order to establish durability of response.
Additionally, the FDA recommended the inclusion of pharmacokinetic assessments, participation of an independent Data Safety Monitoring Board, refinement of statistical methodology, and development of a standalone Statistical Analysis Plan.
The company plans to incorporate these changes into the SKNJCT-005 design and may submit a revised protocol to the FDA.
MDCX closed Tuesday at $0.28, down 12.01%. In the pre-market, shares are trading at $0.29, up 5.96%.
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