First UAE Patient Enrolled in Medicus' Trial for Noninvasive BCC Therapy

Medicus Pharma has announced the treatment of the first patient in the United Arab Emirates (UAE) as part of its SKNJCT-004 phase 2 clinical trial.¹ The study investigates a novel, noninvasive treatment approach for basal cell carcinoma (BCC) of the skin using dissolvable doxorubicin-containing microneedle arrays (D-MNAs).

Global Clinical Expansion

This milestone marks Medicus Pharma’s first international patient enrollment, further expanding its global clinical footprint beyond the United States. The randomized, double-blind, placebo-controlled, multicenter trial will include 36 participants. It is taking place at several sites, including Cleveland Clinic Abu Dhabi, Sheikh Shakhbout Medical City, Burjeel Medical City, Rashid Hospital, Clemenceau Medical Center, and American Hospital of Dubai. The study is being coordinated by Insights Research Organization and Solutions, a UAE-based contract research organization and a portfolio company of M42, a prominent health-tech group.

"Treating our first patient [with BCC] at Cleveland Clinic Abu Dhabi is an important milestone in expanding our clinical study beyond the shores of [the] United States," Raza Bokhari, MD, Medicus executive chairman and CEO, said in a statement. "Nonmelanoma skin diseases, especially BCC, [are] not just an American problem but a global challenge, which we believe represents more than $2 billion [USD] in potential market opportunity."¹

Study Design

Patients will be randomly assigned to 1 of 3 groups: a placebo group, a low-dose group (100 μg of D-MNA), or a high-dose group (200 μg of D-MNA). The high dose was the maximum dose in the 2021 phase 1 safety and tolerability trial (SKNJCT-001; NCT03646188), 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. The trial was initiated in September.²

SKNJCT-003 Trial in the US

Parallel to the UAE study, Medicus is conducting a similar phase 2 trial across 9 sites in the United States. This trial began enrolling patients in August 2024 and is also designed as a randomized, double-blind, placebo-controlled study to assess the efficacy of D-MNA in treating BCC noninvasively.

A positive interim analysis announced in March 2025 reported more than 60% clinical clearance among randomized participants. These results, although promising, were based on data from more than half of the initially targeted 60 patients and are considered preliminary. No systemic effects or clinically significant abnormalities were observed in laboratory parameters, vital signs, electrocardiograms, or physical examinations. Following this, the study was expanded in April 2025 to include up to 90 participants. More than 75% of the expanded cohort has been enrolled.

Next Steps

Medicus received favorable guidance from the US FDA in September 2025 following a Type C meeting. The FDA indicated that the company may pursue a 505(b)(2) regulatory pathway for its SkinJect product, which may streamline the approval process for the D-MNA technology. Medicus is also looking to expand into a pivotal trial that will include between 200 and 400 patients, as well as explore some research opportunities in Europe.

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

References

1. Medicus Pharma Ltd announces first patient treated in United Arab Emirates (UAE) Sknjct-004 phase 2 clinical study to non-invasively treat basal cell carcinoma (BCC) of the skin. News release. Morningstar. October 22, 2025. Accessed October 22, 2025. https://www.morningstar.com/news/accesswire/1090419msn/medicus-pharma-ltd-announces-first-patient-treated-in-united-arab-emirates-uae-sknjct-004-phase-2-clinical-study-to-non-invasively-treat-basal-cell-carcinoma-bcc-of-the-skin

2. 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. September 8, 2025. Accessed October 22, 2025. https://finance.yahoo.com/news/medicus-pharma-ltd-provides-united-113000400.html