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Medicus Provides Addl Context On Topline Dataset From Phase 2 SKNJCT-003 Study Evaluating SkinJect Microneedle Delivery Of D-MNA And P-MNA For BCC; Dataset Shows 73% Clinical Clearance And 40% Histological Clearance In 200-µg Treatment Cohort At Day 57

Benzinga Newsdesk 8 months ago

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Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, today

Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, today provided additional context regarding the recently reported topline dataset from the Phase 2 SKNJCT-003 study evaluating SkinJect® microneedle delivery of D-MNA and P-MNA for basal cell carcinoma (BCC).

The dataset demonstrated 73% clinical clearance and 40% histological clearance in the 200-µg treatment cohort at Day 57, representing the strongest treatment response observed in the study.

We believe that these findings are particularly notable given the device-based mechanism of SkinJect, where microneedle delivery itself may produce biological activity that can contribute to responses observed even in placebo active arm (P-MNA), that was not tip-loaded with the chemotherapeutic agent.

Active placebo arms are not uncommon in device-drug combination trials and can be an acceptable regulatory data point.

The study results demonstrate clear separation in clinical response between the D-MNA treatment arm (73%) and P-MNA treatment arm (38%) in the 200-µg cohort, supporting the continued development of SkinJect as a potential non-surgical treatment option for patients with basal cell carcinoma.

The Company believes the dataset represents decision-grade evidence supporting advancement of the SkinJect program toward regulatory discussions and potential strategic partnerships.

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