Medicus Pharma Partners with Gorlin Syndrome Alliance to Enhance Patient Access
Medicus Pharma Ltd. has announced a strategic partnership with the Gorlin Syndrome Alliance (GSA) aimed at improving access to SKINJECTTM, an investigational microneedle therapy for patients affected by Gorlin Syndrome. This rare genetic disorder results in multiple basal cell carcinomas (BCCs), which can significantly impact the quality of life for those affected. The collaboration will pursue an Expanded Access Investigational New Drug (IND) Program with the U.S. Food and Drug Administration (FDA), facilitating treatment options for patients facing recurrent or inoperable BCCs.
Gorlin Syndrome, affecting approximately one in 31,000 individuals worldwide, often leads to the development of numerous skin cancers over a patient’s lifetime. Traditional treatment methods frequently involve repeated surgeries and topical therapies, which can be both physically and emotionally taxing.
New Treatment Pathways for Patients
Dr. Raza Bokhari, Executive Chairman and CEO of Medicus, expressed the significance of this partnership. “Patients with Gorlin Syndrome endure a lifelong burden of recurring skin cancers that often require repeated surgeries and disfiguring treatments,” he stated. “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, highlighted the collaboration as a vital link between advancements in skin cancer therapies and the real-world needs of patients. She emphasized the importance of incorporating patient feedback to shape access pathways for innovative treatments.
SKINJECTTM represents a non-invasive immunogenic therapy aimed at targeting non-melanoma skin cancers through the use of dissolvable microneedle arrays. Currently, Medicus is engaged in a Phase 2 proof-of-concept trial (SKNJCT-003) involving 90 participants across nine sites in the United States. With more than 75% of participants already enrolled, interim data released earlier this year indicated over 60% clinical clearance in treated lesions.
The FDA has provided encouraging feedback regarding a 505(b)(2) regulatory pathway for SKINJECTTM, laying the groundwork for potential market entry.
Global Expansion and Ongoing Research
In addition to the U.S. study, Medicus is conducting another clinical trial in the United Arab Emirates (SKNJCT-004), coordinated by Insights Research Organization and Solutions, with the Cleveland Clinic Abu Dhabi serving as the principal investigator. This initiative reflects Medicus’ broader strategy to enhance its clinical portfolio, which now encompasses oncology, dermatology, and endocrine disorders.
The partnership with the Gorlin Syndrome Alliance follows Medicus’ recent acquisition of Antev, a U.K.-based biotech firm. Antev specializes in developing Teverelix, a next-generation GnRH antagonist for advanced prostate cancer and acute urinary retention. This acquisition further strengthens Medicus’ commitment to developing non-invasive, precision therapies aimed at improving patient outcomes in complex and underserved disease areas.
As Medicus Pharma and the Gorlin Syndrome Alliance embark on this collaborative journey, they remain dedicated to addressing the needs of patients affected by Gorlin Syndrome, providing new avenues for treatment and support.
