Medicus Pharma (NASDAQ:MDCX) has partnered with the Gorlin Syndrome Alliance (GSA) to expand compassionate access to its investigational microneedle therapy, SKINJECT, for patients suffering from Gorlin Syndrome, a rare genetic condition that causes recurring skin cancers.
Under the collaboration, the two groups will pursue an Expanded Access Investigational New Drug (IND) program with the US Food and Drug Administration (FDA) to allow patients with multiple or inoperable basal cell carcinomas (BCCs) to receive SKINJECT under physician supervision.
Gorlin Syndrome affects about one in 31,000 people worldwide, often resulting in hundreds of BCCs over a patient’s lifetime and requiring repeated surgeries and lifelong dermatologic care.
The initiative also aims to collect real-world safety and tolerability data to support future regulatory filings.
SKINJECT, a doxorubicin-containing microneedle array, is being developed as a localized, non-invasive therapy for non-melanoma skin diseases such as BCC.
“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 and 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.”
Meredith Weiss, Executive Director of the GSA, said the collaboration could “help bridge the gap between breakthroughs in skin cancer therapy and real-world needs faced by Gorlin Syndrome patients,” while giving the patient community a voice in shaping access pathways to new treatments.
Medicus is conducting a Phase 2 proof-of-concept clinical trial, SKNJCT-003, at nine US sites to evaluate SKINJECT for treating BCC. In March 2025, an interim analysis showed more than 60% clinical clearance in patients, and the FDA has since indicated the company may pursue a 505(b)(2) regulatory pathway. Medicus is also running a parallel clinical study in the United Arab Emirates across six hospitals, including Cleveland Clinic Abu Dhabi.
Separately, Medicus recently expanded its pipeline with the August 2025 acquisition of Antev, a UK-based biotech developing Teverelix, a long-acting gonadotrophin-releasing hormone (GnRH) antagonist for prostate conditions in cardiovascular high-risk patients.