Medicus Pharma Achieves 55% Complete Response in Phase 2 BCC Trial, Advancing Toward FDA Registrational Discussions

A 55% histological complete response rate in the 200µg cohort at Day 57 positions Medicus Pharma's Doxorubicin Microneedle Array (D-MNA) as a credible candidate for End-of-Phase 2 (EOP2) discussions with the FDA, with the expanded dataset now providing the dose-response architecture regulators typically require before a registrational pathway is confirmed.

The data come from a pre-specified expanded analysis of 69 participants in the Phase 2 SKNJCT-003 study (NCT06608238), a randomized, double-blind, three-arm trial evaluating two dose levels of microneedle-mediated doxorubicin delivery against a device-only control in patients with nodular basal cell carcinoma. Central pathology reconciliation reduced the evaluable population from 90 randomized participants to 69 who met the nodular BCC inclusion criteria; 21 were reclassified as superficial or mixed subtype lesions.

Across the refined 69-patient cohort, the dose-response gradient sharpened between Day 29 and Day 57. The 200µg D-MNA arm recorded 64% clinical clearance and 55% histological clearance at Day 57, compared with 46% and 27% respectively at Day 29. The device-only control arm held at 29% histological clearance at Day 57, providing a measurable separation that distinguishes drug-driven efficacy from device-mediated biological activity, a distinction that will carry weight in regulatory review.

For development teams tracking novel delivery platforms, the consistency across studies is notable. Results align with Phase 1 observations from the SKNJCT-001 study (March 2021) and the SKNJCT-003 interim analysis reported in March 2025, reinforcing reproducibility across study populations and timepoints. Reproducibility of this kind is a standard regulatory expectation under ICH E9 statistical principles and will be scrutinized during EOP2 review.

The microneedle array delivery mechanism presents a distinct regulatory profile from conventional topical or systemic oncology formulations. Demonstrating dose-dependent response through a device-drug combination adds a layer of CMC and combination product complexity that regulatory affairs leads will need to address as the program moves toward a registrational design. The FDA's combination product framework will govern how the D-MNA is classified and reviewed, and early alignment on that designation will shape the submission strategy.

The company's next disclosed milestone is EOP2 engagement with the FDA, where the refined 69-patient dataset and dose-response evidence will form the core of the registrational discussion.

Source: Medicus Pharma Ltd. via GlobeNewswire, May 6, 2026.