Medicus Pharma Phase 2 BCC data show dose-response at Day 57
Medicus Pharma (NASDAQ: MDCX) has released expanded results from its Phase 2 SKNJCT-003 study of the Doxorubicin Microneedle Array (D-MNA) in nodular basal cell carcinoma, reporting a clear dose-response relationship that the company says supports a path toward registrational discussions with the FDA.
The pre-specified expanded analysis refined the study population to 69 participants confirmed by central pathology as nodular BCC — the most common subtype and the intended target population — from the 90 who were originally randomised. At Day 57, the high-dose 200µg D-MNA cohort achieved 64% clinical clearance and 55% histological clearance, compared with 29% clinical and 29% histological clearance in the device-only control arm. The low-dose 100µg cohort showed intermediate results, at 44% and 33% respectively, consistent with a dose-dependent effect. Importantly, clearance rates improved between Day 29 and Day 57 in the active arms, while the device-only group showed no comparable deepening of response over time.
No drug-related serious adverse events were recorded, and the company reports no evidence of systemic doxorubicin toxicity — a notable finding given that doxorubicin is a well-established cytotoxic agent associated with systemic cardiotoxicity at intravenous doses. The localised microneedle delivery format appears to confine drug activity to the treatment site.
Regulatory path
Medicus said it intends to seek an End-of-Phase 2 meeting with the FDA in the first half of 2026, with the refined 69-patient dataset serving as the primary basis for those discussions. Chairman and chief executive Raza Bokhari described the results as moving the programme "from proof-of-concept to a clear registrational path," though the company stopped short of committing to specific timelines or a Phase 3 design.
The study's principal investigator, Dr Babar Rao of Rutgers Robert Wood Johnson Medical School and Weill Cornell Medical College, stated independently that the dataset demonstrates clinically meaningful rapid-onset efficacy and clear differentiation between drug and device effect — observations that carry weight given the academic credentials of the reviewer, though they have not yet been subject to peer review.
Market context
Basal cell carcinoma is the most frequently diagnosed cancer globally by case volume, and nodular BCC represents the predominant subtype in clinical practice. Current non-surgical options — including topical imiquimod, photodynamic therapy, and the hedgehog pathway inhibitors vismodegib and sonidegib — carry limitations including treatment duration, systemic side-effect profiles, and variable clearance rates in deeper or nodular lesions. The hedgehog inhibitor class in particular is associated with significant tolerability issues on prolonged dosing, leaving room for a well-tolerated, lesion-directed intervention.
D-MNA's profile — local administration, short treatment-to-assessment interval, and a clean safety signal in Phase 2 — positions it as a potentially complementary or pre-surgical option. Medicus estimates the BCC market opportunity at approximately two billion dollars, inclusive of the rarer Gorlin syndrome indication, in which the company is also pursuing an expanded access programme. The competitive landscape is relatively undercrowded for interventional, non-surgical approaches in nodular BCC specifically, though several academic groups are investigating alternative intralesional and immunological strategies.
For investors, the key near-term catalyst is the EOP2 FDA meeting and any subsequent agreement on a registrational trial design, patient selection criteria, and primary endpoint. The company has not disclosed the size or structure of any planned pivotal study, nor has it named a commercial development partner.