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Medicus Pharma Ltd. to Present at Biotech Showcase 2026 as SkinJect Phase 2 Clinical Data Approaches Readout and Partnering Readiness Accelerates
Globenewswire· 2026-01-05 12:30
Core Insights - Medicus Pharma Ltd. is set to present at the Biotech Showcase 2026, highlighting its focus on advancing clinical development programs for innovative therapeutics [1][2] Company Strategy - The company's strategy involves advancing select programs through Phase 2 proof-of-concept and pursuing licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization [5] - Medicus aims to assemble decision-grade clinical, regulatory, and operational data packages aligned with its out-licensing strategy as data matures across its programs [5] Clinical Development Updates - The SkinJect™ Phase 2 program, designed to non-invasively treat basal cell carcinoma (BCC), has achieved execution milestones, including the completion of enrollment of 90 patients in a randomized, double-blind, placebo-controlled study [6][7] - Topline decision-grade Phase 2 results are expected to be reported in the first quarter of 2026, with plans for an End-of-Phase 2 meeting with the FDA in the first half of 2026 [8][31] - Interim findings from the study indicated greater than 60% clinical clearance in an exploratory analysis [9] Regulatory and Geographic Expansion - Medicus has expanded the clinical and regulatory footprint of SkinJect™ to support development and partnering readiness, including approvals in the UK and the UAE for ongoing studies [10][30] - The FDA provided positive feedback regarding the potential use of the 505(b)(2) regulatory pathway for SkinJect™ [11] Collaboration and Partnerships - Medicus has entered a non-binding letter of intent with Reliant AI Inc. to develop an AI-driven clinical data analytics platform aimed at supporting capital-efficient clinical development [15][32] - The company is exploring co-development opportunities with Helix Nanotechnologies for thermostable infectious disease vaccines [17][23] Pipeline Expansion - The acquisition of Antev Limited has added Teverelix, a next-generation GnRH antagonist targeting advanced prostate cancer patients, to Medicus's pipeline [18][24] - Teverelix has shown promising results in previous clinical trials, including a Phase 2a study demonstrating a 97.5% probability of achieving castration levels of testosterone suppression [26] Patient Access Initiatives - Medicus is collaborating with the Gorlin Syndrome Alliance to pursue an Expanded Access IND program for SkinJect™, aiming to provide access to patients with multiple or inoperable BCCs [19][29]