PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) reported additional Phase 2 trial data showing a dose-response relationship for its SkinJect treatment candidate for nodular basal cell carcinoma, with the highest-dose cohort achieving a 55% complete response rate at Day 57.
The expanded analysis came from the company’s SKNJCT-003 Phase 2 study evaluating Doxorubicin Microneedle Array, or D-MNA, for the treatment of nodular basal cell carcinoma, the most common form of skin cancer. Medicus said the findings are expected to support future discussions with the U.S. Food and Drug Administration regarding a potential registrational pathway.
The randomized, double-blind, three-arm study enrolled 90 participants across multiple centers. Patients were assigned to receive either a device-only control, a 100-microgram dose of D-MNA, or a 200-microgram dose.
A subsequent central pathology review determined that 69 participants met the intended nodular basal cell carcinoma inclusion criteria, while 21 participants were found to have superficial or mixed subtype lesions.
According to the company, the refined 69-patient analysis showed progressively stronger treatment responses with higher dosing, with the 200-microgram cohort demonstrating the strongest efficacy signal at Day 57.
Medicus said the higher-dose group showed continued improvement between Day 29 and Day 57, while the device-only control arm demonstrated early biological activity that did not deepen over time.
“The 200µg cohort at Day 57” emerged as “the leading dose with the most robust and consistent efficacy signal,” the company said.
The company said the findings may support future registration-intent or new drug application-enabling discussions with regulators, including decisions related to dose regimen, patient selection, lesion subtype, and treatment timing.
Medicus Chairman and Chief Executive Officer Dr. Raza Bokhari said the expanded dataset “meaningfully strengthens the clinical and regulatory foundation” of the program and moves the company “from proof-of-concept to a clear registrational path.”
The company also reported that D-MNA was generally well tolerated, with no drug-related serious adverse events or evidence of systemic doxorubicin toxicity observed during the study. Reported side effects were primarily mild localized treatment-site reactions.
Independent review of the dataset was provided by Dr. Babar K. Rao, principal investigator of the SKNJCT-003 study and professor of dermatology and pathology at Rutgers Robert Wood Johnson Medical School.
According to Medicus, Rao said the data demonstrated “clinically meaningful rapid onset efficacy” and differentiated between drug-driven effects and device-only activity. The company said he also cited consistency between visual assessments, histologic findings, and central pathology reviews.
Basal cell carcinoma is commonly treated through surgical excision. Medicus said the trial data suggest some lesions treated with the therapy may potentially avoid immediate surgery if future studies confirm the findings.
The company said the data will help guide future study design, including endpoint selection, lesion targeting, and treatment assessment timing.
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