Medicus Pharma (NASDAQ:MDCX) announced that the first patient has been treated in the United Arab Emirates (UAE) as part of its SKNJCT-004 Phase 2 clinical study evaluating a non-invasive treatment for basal cell carcinoma (BCC) of the skin.
The 36-participant study is being conducted across six sites in the UAE, with Cleveland Clinic Abu Dhabi (CCAD) serving as the principal investigator.
Additional sites expected to enroll patients include Sheikh Shakbout Medical City, Burjeel Medical City, Rashid Hospital, Clemenceau Medical Center, and American Hospital of Dubai.
Insights Research Organization and Solutions (IROS), a UAE-based contract research organization and a portfolio company of M42, is coordinating the clinical study.
The SKNJCT-004 trial is a randomized, double-blind, placebo-controlled, multi-center study designed to evaluate the efficacy of two dose levels of Medicus’ dissolvable Doxorubicin-containing microneedle arrays (D-MNA) compared to a placebo control.
Participants will be randomized in equal groups to receive either a placebo, a 100μg low dose, or a 200μg high dose of D-MNA.
The high-dose level was previously tested in Medicus’ Phase 1 safety and tolerability study (SKNJCT-001), completed in March 2021.
"Treating our first BCC patient at Cleveland Clinic Abu Dhabi is an important milestone in expanding our clinical study beyond the shores of the United States,” Medicus CEO Dr Raza Bokhari said in a statement.
"Non-melanoma skin diseases, especially BCC, are not just an American problem but a global challenge which we believe represents more than US$2 billion in potential market opportunity.”
Medicus is also conducting a separate Phase 2 clinical trial, SKNJCT-003, at nine sites across the United States, which began randomizing patients in August 2024.
In March 2025, the company reported a positively trending interim analysis showing over 60% clinical clearance, though it noted the findings were preliminary.
Following approval from an investigational review board in April 2025, the company expanded the US study to 90 participants and has since randomized more than 75% of them.
Additionally, in September 2025, Medicus received positive feedback from the US Food and Drug Administration (FDA) regarding its Type C meeting, indicating that the company may pursue a 505(b)(2) regulatory pathway for its Skinject product candidate.