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Medicus Pharma Ltd. Receives Full United Kingdom Regulatory and Ethical Approvals To Expand Phase 2 Clinical Study (SKNJCT-003) To Non-Invasively Treat Basal Cell Carcinoma (BCC) of the Skin
THE SKNJCT-003 CLINICAL STUDY EXPANSION INTO THE UNITED KINGDOM TO FURTHER ENABLE GLOBAL PATIENT RECRUITMENT AND CLINICAL DATASET TOWARD A PIVOTAL STUDY
About this update from Medicus Pharma Ltd.
[{"type":"text","content":"THE SKNJCT-003 CLINICAL STUDY EXPANSION INTO THE UNITED KINGDOM TO FURTHER ENABLE GLOBAL PATIENT RECRUITMENT AND CLINICAL DATASET TOWARD A PIVOTAL STUDY PROGRAM PHILADELPHIA, PA / ACCESS Newswire / November 13, 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 therapeutics assets, is pleased to announce that it has received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin.The phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States can now expand into additional sites in United Kingdom.The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study wide governance approval, confirming compliance with U.K. Good Clinical Practice and National Health Service (NHS) capacity and capability standards.\"The United Kingdom regulatory and ethical approval is another major step forward in establishing a global footprint of our novel, non-invasive treatment for BCC of the skin, which we believe represents more than $2 billion in potential market opportunity,\" stated Dr. Raza Bokhari, Medicus's Executive Chairman & CEO. \"With clinical development programs now active across United States, Europe, and the Middle East, we are enhancing global patient recruitment and clinical dataset which, among other things, would assist us in designing a robust pivotal program\".SKNJCT-003 Clinical Trial DesignThe SKNJCT-003 clinical study is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 90 subjects presenting with BCC of the skin. The study evaluates 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 re...