The Company Reported 73% Clinical Clearance in the 200-µg cohort at Day 57PHILADELPHIA, March 09, 2026 (GLOBE NEWSWIRE) -- 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 ...

Core Insights - Medicus Pharma Ltd. has announced positive topline results from its Phase 2 clinical study (SKNJCT-003) evaluating the safety and efficacy of Doxorubicin Microneedle Array (D-MNA) for treating basal cell carcinoma (BCC) of the skin, with plans to finalize the Clinical Study Report (CSR) by Q2 2026 to support an end of Phase 2 meeting with the FDA [1][2][7] Clinical Study Overview - The SKNJCT-003 study was a randomized, double-blind, placebo-controlled trial involving 90 patients with nodular type BCC, assessing two dose levels of D-MNA against a placebo [3] - The primary endpoint was defined as achieving both clinical and histological clearance at a specified post-treatment timepoint [3] Topline Results - At Day 29 post-treatment, the clinical clearance rates were 33% for placebo, 47% for the 100µg D-MNA group, and 40% for the 200µg D-MNA group; histological clearance rates were 20%, 24%, and 27% respectively [4] - At Day 57, the 200µg cohort showed the highest activity with 73% clinical clearance and 40% histological clearance [4][6] Management Commentary - The CEO of Medicus expressed encouragement regarding the topline results, viewing them as decision-grade evidence of clinical activity, particularly at the 200µg dose level [5] - The increase in clearance rates at Day 57 supports the sustained biological activity of the treatment and strengthens the company's position in potential partnerships [6][7] Regulatory and Strategic Focus - The final CSR, including full safety analyses, is expected to be completed by Q2 2026, with no anticipated material changes to the reported efficacy findings [7] - The company aims to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships for late-stage development and commercialization [9]

Core Insights - Medicus Pharma Ltd. announced positive topline results from its Phase 2 clinical study (SKNJCT-003) for Doxorubicin Microneedle Array (D-MNA) aimed at treating basal cell carcinoma (BCC) of the skin, indicating potential for FDA engagement and partnership readiness [1][2] Clinical Study Design and Results - The SKNJCT-003 study was a randomized, double-blind, placebo-controlled trial involving 90 patients with nodular BCC, assessing two dose levels of D-MNA against a placebo [3] - The primary endpoint was defined as achieving both clinical and histological clearance at a specified post-treatment timepoint [3] - Topline results showed that at Day 29, the clinical clearance rates were 33% for placebo, 47% for 100µg D-MNA, and 40% for 200µg D-MNA; at Day 57, the rates improved to 38% for placebo, 42% for 100µg D-MNA, and 73% for 200µg D-MNA, with histological clearance rates of 20%, 24%, and 27% respectively at Day 29, and 38%, 33%, and 40% at Day 57 [4] Management Commentary - The CEO of Medicus expressed strong encouragement regarding the topline results, viewing them as decision-grade evidence of clinical activity, particularly at the 200µg dose level [5] - The increase in clearance rates at Day 57 supports the sustained biological activity of the treatment and enhances the company's position in potential partnership discussions [6] Regulatory and Strategic Focus - The final Clinical Study Report (CSR) is expected to be completed in Q2 2026, with no anticipated material changes to the reported efficacy findings [7] - The study was not powered for registrational endpoints, and no conclusions regarding regulatory approval can be drawn at this time [8] - Medicus aims to advance select programs through Phase 2 proof-of-concept and pursue strategic partnerships for late-stage development and commercialization [9]

Core Insights - Medicus Pharma Ltd. has announced that its abstract on Teverelix has been accepted for presentation at the AACE Annual Meeting 2026, highlighting the company's focus on advancing clinical development programs for innovative therapeutics [1][2] Group 1: Teverelix Clinical Data - The accepted abstract titled "Evaluation of Teverelix, a Long-Acting GnRH Antagonist" presents results from two Phase 1 studies involving 48 healthy premenopausal women, assessing pharmacokinetics, pharmacodynamics, bone turnover, and safety [2] - Key findings indicate rapid and reversible hormone suppression with stable bone markers, demonstrating the potential of Teverelix in women's health, particularly for conditions like endometriosis affecting approximately 10% of women of reproductive age [3][7] - The studies showed that Teverelix achieved dose-dependent estradiol suppression, with levels reaching the clinically relevant Barbieri window (30–50 pg/mL), and sustained hormone suppression lasting up to two to three weeks post-injection [7] Group 2: Mechanism and Safety Profile - Teverelix operates as a long-acting injectable GnRH antagonist, providing immediate receptor antagonism and rapid suppression of LH, FSH, and downstream sex hormones without an initial surge [4][16] - The drug has not shown significant cardiovascular safety signals in prior studies, which is particularly relevant for advanced prostate cancer patients with elevated cardiovascular risk [5] Group 3: Development Strategy - Medicus aims to advance select programs through Phase 2 proof-of-concept studies and pursue strategic partnerships for late-stage development and commercialization [8] - The company is also advancing its SkinJect™ program for non-invasive treatment of basal cell carcinoma, with topline data expected in Q1 2026 [9][22] Group 4: Regulatory and Strategic Collaborations - Medicus has received regulatory approvals in the UK for expanding its Phase 2 study evaluating Doxorubicin Microneedle Array for basal cell carcinoma [21] - The company has entered a non-binding memorandum of understanding with Helix Nanotechnologies to explore collaboration on mRNA platform development [13]