Medicus Moves Forward in UAE Trial for Novel, Non-Invasive BCC Therapy

After receiving approval from the United Arab Emirates (UAE) Department of Health in May, Medicus Pharma has begun patient recruitment for its phase 2 clinical study of a non-invasive treatment for basal cell carcinoma (BCC).¹ The therapy, D-MNA, is a novel treatment that aims to be an alternative to Mohs surgery. The trial, SKNJCT-004, is being coordinated in collaboration with Insights Research Organization and Solutions (IROS), a UAE-based contract research organization.

The randomized, double-blind, placebo-controlled, multi-center study will include 36 participants. It is taking place at several sites: Cleveland Clinic Abu Dhabi (CCAD), Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), Rashid Hospital (RH), Clemenceau Medical Center (CMC), and American Hospital of Dubai (AHD). Patients will be randomized into either a placebo group, a low-dose group (100μg of D-MNA), or a high-dose group (200μg of D-MNA). The high dosage was the maximum dose in the 2021 phase 1 safety and tolerability trial (SKNJCT-001), which showed no significant concerns in 13 patients. Researchers reported that 6 participants exhibited complete histological clearance of BCC, all of whom had the nodular subtype.

“Our clinical development program is focusing on the nodular type of BCC, which is the most common subtype, representing 70% of the nearly 5 million new cases in the United States each year. If we can treat the nodular type, we are confident that we will also be able to treat the superficial type as well,” Raza Bokhari, MD, Executive Chairman & CEO of Medicus, said in an interview with Dermatology Times.²

Medicus is also currently conducting a phase 2 US trial (SKNJCT-003), which began at 9 sites in August 2024. Promising interim results were shared in March of this year.² Over 60% of participants reached complete clinical clearance with no dose-limiting toxicities or serious adverse events. Additionally, no systemic effects or clinically significant abnormalities were observed in laboratory parameters, vital signs, ECGs, or physical examinations.

“BCC is not just an American problem but a global problem; especially in regions where Mohs surgeons are not readily available,” Bokhari stated. “We are excited to see our study expand beyond the shores of the United States.”²

With these findings, Medicus seeks the US Food and Drug Administration (FDA)’s guidance on advancing the development program with a new drug application and/or a fast-track designation. They are also looking to expand to a pivotal trial that includes between 200 and 400 patients.

“Our interim findings confirm that our novel therapy is a viable commercial product in development that can become the first in class as well as the best-in-class non-invasive treatment alternative for BCC,” Bokhari said.²

Since then, the investigational review board increased the number of participants in SKNJCT-003 to 90. Last month, Medicus announced that the trial has now randomized more than 75% of the 90 participants expected to be randomized in the study. The company is also looking to expand this research into European programs.

"Commencing patient recruitment in the SKNJCT-004 clinical study at Cleveland Clinic Abu Dhabi is a promising step forward towards our goal to bring to market a first-in-class novel non-invasive alternative to treat BCC,” Bokhari said in a recent statement. "We have already randomized more than 75% of the 90 participants expected to be randomized in our AI-powered SKNJCT-003 study, in the United States, which we believe represents more than US $2 billion in potential market opportunity.”¹

References

1. Medicus Pharma Ltd. Provides Update on United Arab Emirates (UAE) SKNJCT-004 Phase 2 Clinical Study to Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC). News release. Access Newswire. Published September 8, 2025. Accessed September 8, 2025. https://finance.yahoo.com/news/medicus-pharma-ltd-provides-united-113000400.html

2. Medicus pharma ltd announces positively trending interim analysis for SKNJCT-003 phase 2 clinical study to non-invasively treat basal cell carcinoma of the skin (BCC). News release. Medicus Pharma. Published March 6, 2025. Accessed March 7, 2025. https://medicuspharma.com/medicus-pharma-ltd-announces-positively-trending-interim-analysis-for-sknjct-003-phase-2-clinical-study-to-non-invasively-treat-basal-cell-carcinoma-of-the-skin-bcc/