Medicus Pharma (TSX-V:MDCX, NASDAQ:MDCX) announced it has entered into an agreement with healthcare consulting firm Swanielle to explore expanding its Phase 2 clinical study for treating basal cell carcinoma (BCC) into the Asia-Pacific region.
The collaboration aims to identify potential pharmaceutical or biotech partners in Southeast Asia to facilitate this expansion.
Medicus also announced that the Phase 2 study (SKNJCT-003) is currently being conducted at nine clinical sites in the United States, with over 25% of the 60 patients already enrolled.
An interim data analysis is planned for Q1 2025, and Medicus intends to submit these findings to the US Food and Drug Administration (FDA) to request a Type C meeting in Q2 2025.
The meeting aims to align on the clinical pathway and potentially transition the exploratory trial into a pivotal clinical trial to fast-track the program.
The SKNJCT-003 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of investigational product D-MNA at two dose levels (100μg and 200μg) compared to a placebo.
The maximum dose aligns with the dose used in Medicus’ Phase 1 study (SKNJCT-001), completed in March 2021, which demonstrated safety, tolerability, and promising efficacy.
“We are delighted with the progress we have made in advancing the clinical development program of our novel, non-invasive treatment to cure the most common cancer in the world,” Medicus CEO Dr Raza Bokhari said in a statement.
“The collaboration with Swanielle to explore expansion of our clinical study to treat BCC in Southeast Asia will help us gather useful efficacy and safety data which will strengthen the analysis of the pivotal trial that we plan to commence in not-so-distant future.”
The agreement with Swanielle is set for an initial one-year term starting December 1, 2024.
Swanielle will receive a retainer fee of $22,500 and a success fee of 1% to 5%, contingent on securing a qualifying partner.
Swanielle has no financial or securities interests in Medicus.