Medicus Pharma has announced the commencement of the Phase II SKNJCT-004 trial for non-invasive treatment of basal cell carcinoma (BCC) of the skin following approval from the UAE’s Department of Health (DOH) to proceed with the study.
The multi-centre study will assess the efficacy of two dose levels of D-MNA compared to a placebo control.
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It is a double-blind, placebo-controlled (P-MNA) trial and aims to enrol up to 36 subjects with this condition.
The study will randomise these subjects at four sites in the UAE, including the Cleveland Clinic Abu Dhabi, Burjeel Medical City, American Hospital of Dubai, and Sheikh Shakbout Medical City.
It will be coordinated by the UAE-based Insights Research Organization and Solutions.
Subjects will be randomised into three groups: a placebo group, a low-dose group, and a high-dose group receiving P-MNA,100μg and 200μg of D-MNA, respectively.
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By GlobalDataThe proposed high-dose D-MNA is based on the maximum dose utilised in Medicus Pharma’s Phase I tolerability and safety study, SKNJCT-001, completed in March 2021.
This study met its primary objective, with D-MNA tolerated well across all dose levels in all 13 subjects, without any serious adverse events or dose-limiting toxicities reported.
Furthermore, six subjects experienced complete responses, defined as the absence of BCC histologically at the study’s conclusion.
Additionally, Medicus is conducting a Phase II clinical trial, SKNJCT-003, across nine clinical sites in the US, which began subject randomisation last August.
A positively trending interim analysis for SKNJCT-003, conducted in March 2025, showed over 60% clinical clearance after over half of the targeted 60 subjects were randomised.
Following the interim analysis, the investigational review board approved an increase in the participant number to 90 in April.
Medicus also announced the expansion of clinical trial sites into Europe.
In December 2024, the company partnered with Japanese healthcare consultancy Swanielle to extend its Phase II clinical trial for BCC treatment into the Asia-Pacific region.
