PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) reported additional Phase 2 trial data showing higher-dose treatment with its experimental SkinJect therapy produced stronger response rates in patients with nodular basal cell carcinoma, as the company prepares for regulatory discussions with the U.S. Food and Drug Administration.
The expanded analysis from the SKNJCT-003 study found patients receiving the 200-microgram dose of the company’s doxorubicin microneedle array achieved a 55% complete response rate at Day 57, outperforming lower-dose and device-only treatment groups.
The randomized, double-blind Phase 2 study enrolled 90 patients with nodular basal cell carcinoma, the most common form of skin cancer. Participants were divided into three groups receiving either a device-only microneedle array, a 100-microgram dose or a 200-microgram dose.
A subsequent central pathology review determined 69 patients met the intended nodular basal cell carcinoma inclusion criteria, while 21 patients were found to have superficial or mixed-subtype lesions.
According to the company, the refined dataset showed response rates improved between Day 29 and Day 57, with the strongest efficacy signal emerging in the 200-microgram cohort.
The analysis also indicated clearer differentiation between the therapeutic effect of the drug and biological activity associated with the microneedle delivery device itself.
Medicus stated the treatment was generally well tolerated, with no drug-related serious adverse events or evidence of systemic doxorubicin toxicity reported during the study. Most side effects involved mild localized treatment-site reactions.
Chairman and Chief Executive Officer Raza Bokhari said the additional data could support future registration-focused discussions with regulators.
“We believe this dataset moves us from proof-of-concept to a clear registrational path,” Bokhari said in a statement.
The company said the findings could help shape future late-stage studies, including dose selection, lesion targeting and treatment timing.
Independent investigator Babar Rao, a dermatologist and pathology professor at Rutgers Robert Wood Johnson Medical School, reviewed the data and concluded the results demonstrated “clinically meaningful” anti-tumor activity and supported continued development of the therapy, according to Medicus.
SkinJect uses a microneedle-based delivery system to administer doxorubicin directly into skin lesions as a potential non-surgical treatment option for basal cell carcinoma.
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