Medicus Pharma And Gorlin Syndrome Alliance Partner To Expand Access To SKINJECT™ For BCC Patients

Medicus Pharma Ltd. announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to expand compassionate access to SKINJECT™, its investigational microneedle array (D-MNA) therapy containing doxorubicin, designed for patients with Gorlin Syndrome or nevoid basal cell carcinoma syndrome. Through this collaboration, Medicus and GSA will jointly pursue an Expanded Access IND Program with the U.S. FDA, enabling patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to receive SKINJECT™ under physician supervision. The program also aims to collect real-world safety and tolerability data to support future regulatory filings while deepening patient community involvement in trial design and long-term therapy development.

“Patients with Gorlin Syndrome endure a lifelong burden of recurring skin cancers that often require repeated surgeries and disfiguring treatments,” said Dr. Raza Bokhari, Executive Chairman & CEO of Medicus. “By working together with the Gorlin Syndrome Alliance, we hope to unite clinical science, regulatory leadership and advocacy to deliver hope for individuals facing lifelong burdens of Gorlin Syndrome, reinforcing our mission to deliver targeted innovation where medical need is greatest.”

SKINJECT™ represents a novel localized and non-invasive precision therapy for non-melanoma skin cancers, particularly BCC. Medicus is currently advancing Phase 2 study SKNJCT-003 across nine U.S. clinical sites, which began in August 2024. Interim results from March 2025 showed a positive efficacy trend with over 60% clinical clearance, prompting FDA discussions that supported a potential 505(b)(2) regulatory pathway. The trial’s enrollment has been expanded to 90 participants, with over 75% already randomized. In parallel, the company is conducting SKNJCT-004 in the United Arab Emirates (UAE), involving six major hospitals including Cleveland Clinic Abu Dhabi and Sheikh Shakbout Medical City, coordinated by Insights Research Organization and Solutions (IROS), a M42 portfolio company.

“Our families live with a relentless disease, never free, in an endless cycle with cancer. This collaboration may help bridge the gap between breakthroughs in skin cancer therapy and real-world needs faced by Gorlin Syndrome patients,” said Meredith Weiss, GSA Executive Director. “It gives our community a voice in designing pathways to access novel therapies responsibly and ethically. We’re proud to partner with Medicus to explore new therapeutic options that respect the patient voice and accelerate access to innovation.”

In August 2025, Medicus also acquired Antev, a UK-based late-stage biotech company developing Teverelix trifluoroacetate (Teverelix TFA), a next-generation GnRH antagonist for advanced prostate cancer and acute urinary retention relapse. Unlike traditional GnRH agonists, Teverelix directly suppresses testosterone without causing a hormonal surge, potentially reducing cardiovascular risk. Its microcrystalline, long-acting formulation offers a six-week dosing interval, potentially improving compliance and outcomes in cardiovascular high-risk patients.