Medicus Pharma Updates on SKNJCT-003 Phase 2 Study for Nodular BCC Treatment

Medicus Pharma Ltd. has announced significant progress in its phase 2 clinical trial, known as SKNJCT-003, which is actively being conducted at nine locations across the United States. The study has now randomized over half of the expected 60 participants, marking a crucial milestone in the trial's timeline. The trial is designed to assess the efficacy and safety of D-MNA, a novel investigational product, in treating basal cell carcinoma (BCC) of the skin.

The company plans to conduct an interim data analysis before the conclusion of the first quarter of 2025. This analysis will be a pivotal step as Medicus intends to present the findings to the United States Food and Drug Administration (FDA). The goal is to request a Type C meeting with the FDA in the second quarter of 2025, aiming to align on the clinical development pathway and potentially fast-track the program.

The SKNJCT-003 study is structured as a randomized, double-blind, placebo-controlled, multi-center trial involving up to 60 patients with BCC. Participants are divided into three groups: one receiving a placebo (P-MNA), another receiving a low dose (100μg) of D-MNA, and the last group receiving a higher dose (200μg) of D-MNA. The high-dose level was the maximum used in a previous Phase 1 safety and tolerability study (SKNJCT-001), completed in March 2021.

In the earlier Phase 1 trial, SKNJCT-001, D-MNA demonstrated a satisfactory safety and tolerability profile across all administered doses. None of the 13 participants experienced dose-limiting toxicities or serious adverse events. Additionally, there were no significant systemic effects or abnormal findings in laboratory tests, vital signs, ECGs, or physical examinations. The trial also noted the investigational product’s efficacy, as six participants exhibited complete responses, defined by the histological disappearance of BCC in the final excision. All participants who showed complete responses had the nodular subtype of BCC.

Medicus Pharma Ltd., listed on NASDAQ as MDCX, is a biotech company dedicated to advancing the clinical development of innovative therapeutic assets. Its subsidiary, SkinJect Inc., focuses on developing and commercializing a novel, non-invasive treatment for basal cell skin cancer. This treatment utilizes a patented dissolvable microneedle patch designed to deliver a chemotherapeutic agent directly to tumor cells.

The phase 2 study underway builds upon the encouraging results of the phase 1 trial. The randomized, controlled, double-blind, multicenter phase 2 study seeks to further validate the efficacy of D-MNA in nodular BCC patients. Medicus expects to randomize up to 60 patients, with recruitment progressing at multiple sites in the U.S. This study represents a critical component of Medicus's broader strategy to bring innovative cancer treatments to market efficiently.

As Medicus advances its clinical program, the upcoming interim analysis and the anticipated Type C meeting with the FDA could significantly influence the future trajectory of D-MNA’s development. With a focus on streamlining the clinical pathway, Medicus aims to deliver disruptive therapeutic solutions for skin cancer patients, addressing a critical need in the oncology field.