Medicus Pharma (NASDAQ:MDCX) has reported additional results from a pre-specified expanded dataset analysis of its Phase 2 SKNJCT-003 trial, showing a positive dose-response relationship for its Doxorubicin Microneedle Array (D-MNA) in treating nodular basal cell carcinoma (BCC).
The analysis builds on previously disclosed topline results and incorporates biological, histologic, and safety data from a refined group of 69 patients whose diagnoses met the study’s intended inclusion criteria.
The company said the findings may support future regulatory discussions with the US Food and Drug Administration as it advances the program.
The randomized, double-blind, three-arm study evaluated two dose levels of D-MNA, 100 micrograms and 200 micrograms, against a device-only control in patients with nodular BCC. Participants were assessed at 29 and 57 days following treatment.
According to the expanded analysis, outcomes improved over time and showed a dose-dependent pattern. At Day 57, the 200 microgram group demonstrated the highest response rates, with clinical clearance observed in 64% of patients and histological clearance in 55%. This compared with 44% and 33%, respectively, in the 100 microgram group, and 29% for both measures in the device-only arm.
Earlier timepoint data at Day 29 showed more limited differentiation between groups, though the higher-dose cohort still recorded the strongest results. The company said the increasing separation by Day 57 supports a drug-driven therapeutic effect rather than a response attributable solely to the microneedle device.
Medicus stated that the expanded dataset reinforces trends seen in prior analyses, including earlier Phase 1 findings and interim Phase 2 data, suggesting reproducibility across studies.
The company added that the results provide a more precise view of treatment effect and may help guide future study design and endpoint selection ahead of end-of-Phase 2 regulatory discussions.
Safety findings remained consistent with earlier reports. The treatment was generally well tolerated, with no drug-related serious adverse events or evidence of systemic doxorubicin toxicity. Reported side effects were primarily mild, localized reactions at the treatment site.
The company noted that the device-only arm showed some early biological activity, potentially linked to a localized immune response, but did not demonstrate sustained improvement over time. In contrast, the higher-dose D-MNA cohort showed continued gains between Day 29 and Day 57 across both clinical and histological measures.
“We are encouraged by these additional findings in the expanded analysis, which we believe meaningfully strengthens the clinical and regulatory foundation of the SKNJCT-003 Program” Medicus CEO Dr Raza Bokhari said in a statement.
“We are confident that this dataset moves us from Proof-of-concept to a clear registrational path, and we believe Skinject has the potential to fundamentally change the current approach of treating patients with BCC, addressing a major un-met medical need."
An independent investigator involved in the study, Dr Babar Rao of Rutgers Robert Wood Johnson Medical School, said the dataset indicates rapid onset of efficacy and consistency across visual and pathological assessments, supporting further clinical development.
Shares of Medicus gained around 9.3% on the Nasdaq in early Wednesday trading.