Medicus Pharma Ltd. (NASDAQ:MDCX) has received comprehensive regulatory and ethical approvals from United Kingdom authorities to expand its ongoing Phase 2 clinical study evaluating a novel microneedle array treatment for basal cell carcinoma (BCC) of the skin. The approvals mark a significant milestone in the company's global clinical development strategy for its investigational therapy.
Regulatory Approvals Enable International Expansion
The UK's Medicines and Healthcare products Regulatory Agency (MHRA), Health Research Authority (HRA), and Wales Research Ethics Committee (WREC) granted the necessary approvals following comprehensive scientific review. The MHRA approval followed evaluation of the Investigational Medicinal Product Dossier (IMPD) and protocol, while the WREC issued a favorable ethical opinion and the HRA granted study-wide governance approval, confirming compliance with UK Good Clinical Practice and National Health Service standards.
"The United Kingdom regulatory and ethical approval is another major step forward in establishing a global footprint of our novel, non-invasive treatment for BCC of the skin, which we believe represents more than $2 billion in potential market opportunity," stated Dr. Raza Bokhari, Medicus's Executive Chairman & CEO.
Phase 2 Study Design and Interim Results
The SKNJCT-003 clinical study is designed as a randomized, double-blind, placebo-controlled, multi-center study enrolling up to 90 subjects with BCC of the skin. The study evaluates two dose levels of Doxorubicin Microneedle Array (D-MNA) compared to a placebo control, with participants randomized 1:1:1 to three groups: placebo-controlled group receiving P-MNA, low-dose group receiving 100μg of D-MNA, and high-dose group receiving 200μg of D-MNA.
The high-dose 200μg D-MNA represents the maximum dose used in the company's completed Phase 1 safety and tolerability study (SKNJCT-001) from March 2021. That earlier study met its primary objective of safety and tolerability, with the investigational product well tolerated across all dose levels in 13 participants, showing no dose-limiting toxicities or serious adverse events.
In March 2025, Medicus announced positively trending interim analysis results for SKNJCT-003, demonstrating more than 60% clinical clearance. The interim analysis was conducted after more than 50% of the then-targeted 60 patients were randomized. The company notes that these preliminary findings may or may not correlate with final study results upon completion.
Global Clinical Development Strategy
The Phase 2 study, currently underway at nine clinical sites in the United States, can now expand into additional UK sites. The company has randomized more than 75% of the 90 participants expected in the study and is expanding trial sites across Europe. With clinical development programs now active across the United States, Europe, and the Middle East, Medicus aims to enhance global patient recruitment and clinical datasets to support future pivotal program design.
The company also operates a clinical study (SKNJCT-004) in the United Arab Emirates, expected to randomize 36 patients across six sites including Cleveland Clinic Abu Dhabi, Sheikh Shakbout Medical City, Burjeel Medical City, Rashid Hospital, Clemenceau Medical Center, and American Hospital of Dubai.
Regulatory Pathway and Market Opportunity
In September 2025, Medicus received positive feedback from the Food and Drug Administration regarding its Type C meeting supporting Skinject development, indicating the company may follow the 505(b)(2) regulatory pathway for non-invasive BCC treatment using dissolvable D-MNA.
The company has also established a strategic collaboration with the Gorlin Syndrome Alliance to advance compassionate access to SKINJECT for patients with Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome. Under this collaboration, Medicus and the GSA will jointly pursue an Expanded Access IND Program with the FDA to allow patients with multiple, recurrent, or inoperable basal cell carcinomas access to SKINJECT under physician-supervised treatment protocols.
