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Medicus Pharma Reports Positive Phase 2 SKNJCT-003 Topline Data Observing 73% Clinical Clearance and 40% Histological Clearance (CR) at Day 57 in 200μg Cohort
The Company is expected to finalize the Clinical Study Report (CSR) in Q2 2026 to support planned end of Phase 2 (EOP2) meeting with the FDA PHILADELPHIA,
About this update from Medicus Pharma Ltd.
[{"type":"text","content":"The Company is expected to finalize the Clinical Study Report (CSR) in Q2 2026 to support planned end of Phase 2 (EOP2) meeting with the FDA\nPHILADELPHIA, March 05, 2026 (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 topline results from its Phase 2 clinical study (SKNJCT-003) evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin. The Company believes the topline results are not only positive but decision-grade that should support an end of phase 2 (EOP2) meeting with the FDA in the first half of 2026 as well as accelerate partnering readiness. SKNJCT-003 Clinical Trial Design and Topline Results: The SKNJCT-003 clinical study was designed as a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling 90 patients presenting with nodular type BCC of the skin. The study evaluated the safety and efficacy of two dose levels of D-MNA compared to placebo control. Participants were randomized 1:1:1 into three groups: Placebo-controlled group receiving P-MNALow-dose group receiving 100μg of D-MNAHigh-dose group receiving 200μg of D-MNA The primary endpoint for treatment of BCC is a binary, multi-component endpoint defined as achieving both clinical and histological clearance (i.e. the proportion of patients demonstrating both clinical (visual) clearance and histological clearance (CR) at a prespecified post-treatment timepoint. The prespecified post-treatment timepoints at the end of the study were: Day 29 for 47 patientsDay 57 for 43 patients The Topline results are tabulated below: Dose# of patients(n)Day 29 post-treatment# of patients(n)Day 57 post-treatment 47Clinical ClearanceHistological Clearance (CR)43Clinical ClearanceHistological Clearance (CR)Placebo15 33% 20%16 38%38%100ug D-MNA1747%24%1242%33%200ug D-MNA1540%27%1573%40% The dataset demonstrates that clearance rates increased between Day 29 and Day 57, consistent with continued biological activity over time. The 200µg cohort demonstrated the highest observed activity at Day 57, achieving 73% Clinical Clearance and 40% Histological Clearance (CR). “We are extremely ...