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Medicus Pharma Ltd. Provides Update on Doxorubicin Containing Novel Microneedle Array (D-MNA) Clinical Development Program for the Treatment of Basal Cell Carcinoma (BCC) of the Skin and Reports Second Quarter 2025 Financial Highlights
US Food and Drug Administration (FDA) has accepted the company's Type C meeting request and SKNJCT-003 Phase 2 study has randomized more than 75% of patients
About this update from Medicus Pharma Ltd.
[{"type":"text","content":"US Food and Drug Administration (FDA) has accepted the company's Type C meeting request and SKNJCT-003 Phase 2 study has randomized more than 75% of patients\nPhiladelphia, Pennsylvania--(Newsfile Corp. - August 21, 2025) - 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 therapeutic assets, is pleased to announce, following the acceptance of the Type C meeting request by the United States Food and Drug Administration (the \"FDA\"), the Company has submitted its queries in writing and expect to receive a response from the FDA before the end of Q3 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.\nThe Company also announced that its phase 2 clinical study to non-invasively treat BCC using novel D-MNA (SKNJCT-003) has now randomized more than seventy five percent (75%) of the ninety (90) participants expected to be randomized in the study.\nClinical Trial Design\nThe clinical study (SKNJCT-003) is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study originally enrolling up to sixty (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 200μg of D-MNA.\nThe high-dose, 200μg D-MNA, proposed in the study is the maximum dose that was used in the Company's Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021.\nSKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA, was well tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), or serious adverse events (SAEs). Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, EC...