PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) issued a clarification of previously reported Phase 2 trial results for its SkinJect therapy in nodular basal cell carcinoma, the company said.
The clarification addresses how topline data released in March should be interpreted, particularly regarding a device-only study arm that does not contain active drug, according to the company.
Medicus said the device-only arm was included for scientific context but is not relevant to the therapy’s clinical development or regulatory pathway. The company stated its focus remains on active treatment arms using doxorubicin delivered via a microneedle array.
In the Phase 2 study, patients receiving active treatment at doses of 100 micrograms and 200 micrograms showed measurable clinical activity, forming the basis for future development decisions, the company said.
The 200-microgram dose demonstrated the highest level of activity, with continued improvement observed through 57 days following treatment, according to the topline dataset.
The company described the trial as a proof-of-concept study focused on clinical clearance of tumors and said further analysis will be included in a forthcoming clinical study report.
Medicus said that report will emphasize results from the active treatment groups, including clinical and histological outcomes and dose-response data, while treating the device-only arm as supportive information.
The company said it plans to advance development using the 200-microgram dose and will refine study design, endpoints, and treatment protocols in consultation with regulators at a planned end-of-Phase 2 meeting.
“We believe the positive topline results from 200 ug cohort at day 57 support the therapeutic value of SkinJect,” Chief Executive Officer Raza Bokhari said.
SkinJect is an investigational drug-device therapy designed to deliver chemotherapy directly into tumors using a microneedle array as a potential non-surgical treatment for basal cell carcinoma, the company said.
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