Medicus Pharma Ltd. (NASDAQ: MDCX) is making significant strides in the development of SKNJCT, a novel non-invasive treatment for basal cell carcinoma (BCC), the most common skin cancer. The company's Phase 2 clinical trial, SKNJCT-003, is currently underway across nine sites in the United States and has randomized over 50% of the targeted 60 patients.
Clinical Trial Progress
The Phase 2 study is designed as a randomized, double-blind, placebo-controlled, multi-center trial. Participants are being randomized in a 1:1:1 ratio to receive either a placebo (P-MNA), a low dose (100μg) of D-MNA, or a high dose (200μg) of D-MNA. The primary endpoint is to evaluate the efficacy of the two dose levels of D-MNA compared to placebo in subjects with nodular BCC.
Medicus Pharma is on track to complete an interim data analysis by the end of Q1 2025. Following this analysis, the company plans to submit its findings to the U.S. Food and Drug Administration (FDA) as part of a package seeking a Type C meeting in Q2 2025. The goal of this meeting is to discuss product development and gain alignment on the clinical pathway, with the aim of securing a fast-track designation for the clinical development program.
Asia-Pacific Expansion
To further expand the reach of its clinical trials, Medicus Pharma has entered into a collaboration agreement with Swanielle Inc., a healthcare consulting firm, to explore the expansion of the Phase 2 study into the Asia-Pacific region. This collaboration aims to identify potential partners in Southeast Asia to facilitate the study's expansion, particularly in regions where access to surgical options for BCC treatment is limited.
According to Medicus Pharma CEO Dr. Raza Bokhari, the collaboration with Swanielle will help gather useful efficacy and safety data, strengthening the analysis of the pivotal trial planned for the future. The agreement with Swanielle has an initial term of one year, with Swanielle receiving a retainer fee and a success fee dependent on the execution of a definitive agreement with a qualifying partner.
Promising Phase 1 Results
The Phase 2 study builds upon the positive results from the company's Phase 1 safety and tolerability study (SKNJCT-001), completed in March 2021. The Phase 1 study met its primary objective of safety and tolerability, with D-MNA being well-tolerated across all dose levels. Notably, six of the thirteen participants in the Phase 1 study experienced complete responses, defined as the disappearance of BCC histologically in the final excision.
Dr. Bokhari expressed confidence in the potential of SKNJCT, stating that the company aims to secure a fast-track designation from the FDA, expand the trial to a pivotal study involving up to 400 patients, and clarify the regulatory pathway to commercialization. The company's goal is to bring a commercially viable product to market before the end of 2027, offering a non-invasive, cost-effective, and aesthetically pleasing alternative to surgical intervention for basal cell carcinoma.
