Medicus Pharma completes enrollment in Phase 2 skin cancer microneedle study

Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to announce another major clinical milestone for the company, confirming that enrollment has been successfully completed in its Phase 2 clinical study evaluating the safety and efficacy of its Doxorubicin Microneedle Array (D-MNA), also known as SKNJCT-003, for the non-invasive treatment of nodular basal cell carcinoma (BCC) of the skin. The Phase 2 study has enrolled a total of 90 patients across nine clinical sites in the United States and is currently underway. Completion of enrollment represents a key step forward in Medicus Pharma’s development strategy, positioning the company to advance discussions with regulators and accelerate progress toward later-stage trials. Dr. Bokhari explained that the company expects to report topline results from the SKNJCT-003 study in the first quarter of 2026. Following the release of these data, Medicus Pharma plans to pursue an end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration in the first half of 2026 to discuss the next steps in the clinical and regulatory pathway. SKNJCT-003 is a randomized, double-blind, placebo-controlled, multi-center study designed to evaluate two dose levels of the Doxorubicin Microneedle Array compared with a placebo microneedle array (P-MNA). Participants are randomized on a 1:1:1 basis into three treatment arms: a placebo group receiving P-MNA, a low-dose group receiving 100 micrograms of D-MNA, and a high-dose group receiving 200 micrograms of D-MNA. The high-dose 200 microgram D-MNA represents the maximum dose previously tested in the company’s Phase 1 safety and tolerability study, SKNJCT-001, which was successfully completed in March 2021. The Phase 2 trial builds on that foundation, aiming to further validate both safety and therapeutic effectiveness in a larger patient population. Medicus Pharma’s microneedle-based approach is designed to deliver chemotherapy directly into skin lesions while avoiding the need for invasive surgery, offering the potential for improved patient comfort, cosmetic outcomes, and treatment accessibility. The successful completion of enrollment marks a critical inflection point as the company advances toward potential late-stage development and regulatory engagement. #proactiveinvestors #nasdaq #mdcx #tsxv #mdcx #pharma #Biotech #CancerTreatment #ClinicalTrials #FDAApproval #SkinCancer #HealthcareInnovation #Investing #MedicalResearch #SkinCancer #BasalCellCarcinoma #BiotechNews #CancerResearch #GorlinSyndrome #BasalCellCarcinoma #CompassionateUse #FDAApproval #RareDiseaseTreatment #NoninvasiveTherapy #BiotechNews