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Medicus Pharma Ltd. Announces Submission of Type C Meeting Request to the Food and Drug Administration (FDA)
The Company's aim is to seek FDA consent to fast track the Clinical Development Program to treat Basal Cell Carcinoma (BCC) of the skin using Dissolvable
About this update from Medicus Pharma Ltd.
[{"type":"text","content":"The Company's aim is to seek FDA consent to fast track the Clinical Development Program to treat Basal Cell Carcinoma (BCC) of the skin using Dissolvable Doxorubicin-containing Microneedle Arrays (D-MNA)\nPhiladelphia, Pennsylvania--(Newsfile Corp. - July 8, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) (\"Medicus\" or the \"Company\") is pleased to announce submission of a comprehensive package to the United States Food and Drug Administration (the \"FDA\") seeking a Type C meeting with the FDA during the week of October 6th, 2025.\nThe purpose of the Type C meeting is to formally discuss the D-MNA product development and gain further alignment on the clinical pathway. The Company's aim is to gain the FDA's consent to fast-track the clinical development program and seek feedback on future clinical plans for the D-MNA development program. More specifically, a list of draft questions and key topics seeking the FDA's feedback are:\n\n\nBased on the robust systemic safety margin (when considering the relative bioavailability of the topical patch as compared to traditional parenteral routes), the Company has chosen to explore doses that provide the greatest possibility of efficacy. Does the FDA agree with the doses selected for future study?\n\n\nDoes the FDA agree that complete histological clearance at 6 weeks post-treatment is an appropriate primary endpoint for the next study?\n\n\nDoes the FDA agree with the proposed patient population definition, including tumor size limits, location restrictions, and histological confirmation requirements?\n\n\nDoes the FDA agree that a randomized, double-blind, vehicle-controlled study design is appropriate for future studies that are intended to demonstrate the effectiveness of D-MNA in treating BCC?\n\n\nDoes the FDA agree that the current safety assessments are adequate for the proposed future study(ies)?\n\n\nClinical Trial Design\nThe clinical study (SKNJCT-003) is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 60 subjects presenting with BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to a placebo control. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving ...