Medicus Pharma Completes Phase 2 Enrollment of D-MNA Study to Non-Invasively Treat BCC

Medicus Pharma recently announced that it has completed enrollment of 90 US patients in its phase 2 study evaluating the safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to non-invasively treat nodular basal cell carcinoma (BCC). Medicus plans to release topline results from its phase 2 study, SKNJCT-003, in the first quarter of 2026 and also confirm an end-of-phase 2 FDA meeting in the first half of 2026.¹

“Successfully completing the US enrollment of 90 patients for SKNJCT-003 brings us one more step closer to bringing to market a non-invasive, patient friendly, cost effective, localized immune therapy to treat basal cell carcinoma of the skin which we believe represents ~$2 billion in potential market opportunity,” said Raza Bokhari, MD, Executive Chairman and CEO of Medicus, in the news release. “We are very hopeful that the clinical study report expected in H1 2026 will reaffirm the positively trending preliminary interim data analysis that the Company released earlier this year in Q1 2025 which showed more than 60% clinical clearance in 26 patients.”

The SKNJCT-003 clinical study is a randomized, double-blind, placebo-controlled (P-MNA), multi-center study evaluating the efficacy of 2 dose levels of D-MNA compared to a placebo control. The patients enrolled across 9 clinical sites will be randomized 1:1:1 to one of 3 groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA.¹

“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,” Bokhari previously told Dermatology Times.

According to the announcement, the high dose from phase 2 is the maximum dose that was originally used in the phase 1 safety and tolerability study that concluded in March 2021.¹

The phase 1 study achieved its primary end point, demonstrating an acceptable safety and tolerability profile. The investigational agent D-MNA was well tolerated at all administered dose levels among the 13 enrolled participants, with no reported dose-limiting toxicities or serious adverse events. In addition, no systemic effects or clinically meaningful abnormalities were observed in laboratory assessments, vital signs, electrocardiograms, or physical examination findings.^1,2

Efficacy outcomes were also reported, with complete responses observed in 6 participants. A complete response was defined as histologic absence of basal cell carcinoma on final excision at the end-of-study visit. Participants achieving complete responses represented a heterogeneous clinical profile; however, all 6 had nodular basal cell carcinoma.²

Future Outlook

The clinical and regulatory trajectory for SkinJect and D-MNA continues to progress across multiple programs. In March 2025, Medicus reported a positively trending interim analysis from the phase 2 SKNJCT-003 study, demonstrating greater than 60% clinical clearance. This analysis was conducted after more than 50% of the initially targeted 60 patients had been randomized. These findings remain preliminary, and final outcomes may differ once the study is fully completed.¹

Regulatory engagement advanced in September 2025, when Medicus received positive feedback from the FDA following a Type C meeting. The FDA indicated that the SkinJect program may be eligible to proceed under the 505(b)(2) regulatory pathway for the noninvasive treatment of BCC of the skin using dissolvable D-MNA.¹

Geographic expansion of clinical evaluation is also underway. In October 2025, the first patient was treated in SKNJCT-004, an ongoing study in the United Arab Emirates. The trial is expected to enroll 36 patients across 6 sites, with Cleveland Clinic Abu Dhabi serving as the principal investigator. The study is being coordinated by Insights Research Organization and Solutions, a UAE-based contract research organization within the M42 portfolio.¹

Further regulatory momentum was achieved in November 2025, when full approvals were granted in the United Kingdom to expand the phase 2 SKNJCT-003 study. These approvals were issued by the Medicines and Healthcare products Regulatory Agency, the Health Research Authority, and the Wales Research Ethics Committee, confirming compliance with UK Good Clinical Practice and National Health Service standards following comprehensive scientific and ethical review.¹

Patient access initiatives are also being incorporated into long-term strategy. In October 2025, Medicus announced a collaboration with the Gorlin Syndrome Alliance to pursue an Expanded Access IND program with the FDA, enabling physician-supervised access to SkinJect for patients with multiple, recurrent, or inoperable basal cell carcinomas while generating real-world safety and tolerability data.¹

References

1. Medicus Pharma Ltd. completes enrolment of ninety (90) patients for phase 2 clinical study (SKNJCT-003) to non-invasively treat basal cell carcinoma (BCC) of the skin. News release. Medicus Pharma. December 15, 2025. Accessed December 15, 2025. https://medicuspharma.com/medicus-pharma-ltd-completes-enrolment-of-ninety-90-patients-for-phase-2-clinical-study-sknjct-003-to-non-invasively-treat-basal-cell-carcinoma-bcc-of-the-skin/
2. Medicus Pharma Ltd publishes phase 1 clinical study report demonstrating safety & tolerability in all participants with basal cell carcinoma. News release. Medicus Pharma. February 15, 2024. Accessed December 15, 2025. https://medicuspharma.com/medicus-pharma-ltd-publishes-phase-1-clinical-study-report-demonstrating-safety-tolerability-in-all-participants-with-basal-cell-carcinoma/