Medicus Pharma has officially launched the Phase II SKNJCT-004 trial aimed at exploring a non-invasive treatment for basal cell carcinoma (BCC) of the skin after receiving authorization from the UAE’s Department of Health (DOH).
This multi-center research project will evaluate the effectiveness of two different dosage levels of D-MNA in comparison to a placebo.
Designed as a double-blind, placebo-controlled trial, the study plans to recruit up to 36 participants suffering from this condition.
The participant recruitment will occur at four locations in the UAE, which include Cleveland Clinic Abu Dhabi, Burjeel Medical City, American Hospital of Dubai, and Sheikh Shakbout Medical City.
The oversight of this trial will be managed by Insights Research Organization and Solutions, situated in the UAE.
Participants will be divided into three categories: a placebo group, a low-dose group, and a high-dose group receiving 100μg and 200μg of D-MNA, respectively.
The proposed high dosage of D-MNA is derived from the maximum dosage utilized in Medicus Pharma’s earlier Phase I safety and tolerability study, SKNJCT-001, which was completed in March 2021.
This initial study successfully met its primary goal, showing that D-MNA was well tolerated at all dosage levels among the 13 participants, without any serious adverse effects or dose-related toxicities reported.
Moreover, six of the participants demonstrated complete responses, noted as the absence of BCC histologically at the study’s end.
In addition, Medicus is proceeding with another Phase II trial, SKNJCT-003, which spans nine clinical sites across the United States and commenced participant randomization last August.
As of a positive interim analysis for SKNJCT-003 reported in March 2025, more than 60% of participants exhibited clinical clearance after randomizing more than half of the targeted enrollment of 60 subjects.
In response to the interim findings, the investigational review board approved an increase in participant enrollment to 90 in April.
Medicus has also revealed plans to expand its clinical trial efforts into Europe.
In December 2024, the company established a partnership with the Japanese healthcare consultancy Swanielle to broaden its Phase II trial for BCC treatment into the Asia-Pacific region.