Business
Medicus Pharma Ltd. Completes Enrolment of Ninety (90) Patients for Phase 2 Clinical Study (SKNJCT-003) to Non-Invasively Treat Basal Cell Carcinoma (BCC) of the Skin
THE COMPANY EXPECTS TO RELEASE TOPLINE RESULTS FOR SKNJCT-003 PHASE 2 CLINICAL TRIAL BEFORE THE END OF Q1 2026 AND REQUEST END-OF-PHASE 2 (EOP2) WITH THE FOOD
About this update from Medicus Pharma Ltd.
[{"type":"text","content":"THE COMPANY EXPECTS TO RELEASE TOPLINE RESULTS FOR SKNJCT-003 PHASE 2 CLINICAL TRIAL BEFORE THE END OF Q1 2026 AND REQUEST END-OF-PHASE 2 (EOP2) WITH THE FOOD AND DRUG ADMINISTRATION (FDA) IN H1 2026 PHILADELPHIA, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (\"Medicus\" or the \"Company\"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that its Phase 2 clinical study (SKNJCT-003) evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to non-invasively treat nodular basal cell carcinoma (BCC) of the skin, has successfully completed enrolment of ninety (90) patients in the United States. The phase 2 clinical study (SKNJCT-003) is currently underway in nine (9) clinical sites in United States. The company expects to release topline results for SKNJCT-003 in the first quarter of 2026 and secure an end of phase 2 (EOP2) meeting with the FDA in the first half of 2026. “Successfully completing the U.S. enrollment of 90 patients for SKNJCT-003 brings us one more step closer to bringing to market a non-invasive, patient friendly, cost effective, localized immune therapy to treat basal cell carcinoma of the skin which we believe represents ~$2 billion in potential market opportunity” stated Dr. Raza Bokhari, Medicus’s Executive Chairman & CEO. “We are very hopeful that the clinical study report expected in H1 2026 will reaffirm the positively trending preliminary interim data analysis that the Company released earlier this year in Q1 2025 which showed more than 60% clinical clearance in 26 patients.” SKNJCT-003 Clinical Trial Design The SKNJCT-003 clinical study is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 90 subjects presenting with BCC of the skin. The study evaluates the efficacy of two dose levels of D-MNA compared to a placebo control. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA. The high-dose, 200μg D-MNA, in the study is the maximum dose that was used in the Company’s Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021. SKNJCT-001 me...