Medicus Pharma Ltd. to Expand Phase 2 Clinical Study in Asia Pacific through Collaboration

Medicus Pharma Ltd. has announced a significant development in its ongoing efforts to combat Nodular Basal Cell Carcinoma (BCC). The company has entered into a new agreement with Swanielle Inc., a healthcare consulting firm, to explore expanding their current Phase 2 clinical study into the Asia-Pacific region. The objective is to identify potential pharmaceutical or biotech partners in Southeast Asia that could collaborate with Medicus to facilitate this expansion.

The Phase 2 clinical study, designated as SKNJCT-003, is currently active across nine clinical sites in the United States. To date, over 25% of the targeted 60 patients have been enrolled in the study. Medicus plans to conduct an interim data analysis in the first quarter of 2025. The results from this analysis will be submitted to the United States Food and Drug Administration (FDA) to request a Type C meeting in the second quarter of 2025. The purpose of this meeting is to discuss the development pathway of the product and align further steps for its clinical development. The company aims to accelerate the clinical development program and transition the SKNJCT-003 study from an exploratory phase to a pivotal clinical trial.

SKNJCT-003 is structured as a randomized, double-blind, placebo-controlled, multi-center study involving up to 60 patients diagnosed with BCC. The study aims to compare the efficacy of two different doses of D-MNA (100µg and 200µg) against a placebo control. Participants are randomly assigned 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.

The higher dose of 200µg D-MNA used in the Phase 2 study was previously tested in Medicus's Phase 1 safety and tolerability study (SKNJCT-001), which was completed in March 2021. The Phase 1 study met its primary objectives, demonstrating that D-MNA was well-tolerated across all dosage levels without any dose-limiting toxicities or serious adverse events. Thirteen participants were enrolled in the Phase 1 study, and no significant abnormalities were observed in laboratory parameters, vital signs, ECGs, or physical examinations. Furthermore, the investigational product’s efficacy was noted, as six participants experienced complete responses, defined as the total disappearance of BCC in final histological examination.

Dr. Raza Bokhari, Executive Chairman and CEO of Medicus, expressed enthusiasm about the progress made in the clinical development of their non-invasive treatment for BCC, the most common type of cancer globally. He highlighted that the collaboration with Swanielle to explore the study's expansion into Southeast Asia could provide additional efficacy and safety data. This data would strengthen the analysis of the pivotal trial they plan to launch shortly.

The agreement with Swanielle began on December 1, 2024, and has an initial term of one year. Under the terms, Swanielle will receive a retainer fee of $22,500, and a success fee ranging from 1% to 5% based on the completion of a definitive agreement with a qualifying partner.

Medicus Pharma Ltd. is a biotech and life sciences company dedicated to the rapid development of groundbreaking therapeutic assets. Its subsidiary, SkinJect Inc., focuses on commercializing non-invasive treatments for basal cell skin cancer using a patented microneedle patch to deliver a chemotherapeutic agent directly to tumor cells. Medicus’s Phase 2 clinical trial (SKNJCT-003) is underway, and patient recruitment is ongoing at nine sites across the United States.