Medicus Reports Promising Interim Results for Non-Invasive BCC Treatment

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This week, Medicus reported a positively trending interim analysis for its SKNJCT-003 phase 2 clinical study. The study is focused on evaluating a non-invasive treatment for basal cell carcinoma (BCC) using the investigational product D-MNA. Conducted at 9 clinical sites across the United States, the study aims to enroll 60 participants, with an interim analysis completed after over 50% of the target enrollment was achieved.¹

In addition to a news release from the company, Dermatology Times spoke with Raza Bokhari, MD, CEO pf Medicus Pharma, to gain further insights into the clinical data.

“D-MNA is a novel non-invasive treatment alternative for BCC. The current standard of care is surgical intervention (Mohs Surgery), which is effective, but painful, expensive and aesthetically not very pleasing,” Bokhari said. “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.”

Interim Analysis Findings

The interim data suggests a promising trend, with over 60% of enrolled subjects achieving complete clinical clearance. Additionally, D-MNA has demonstrated a favorable safety profile across both dosage groups—100μg and 200μg. No dose-limiting toxicities (DLTs) or serious adverse events have been reported, and no systemic effects or clinically significant abnormalities were observed in laboratory parameters, vital signs, ECGs, or physical examinations. These findings, while encouraging, remain preliminary and may not necessarily predict final study outcomes.

“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 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 noted.

Clinical Trial Design

The SKNJCT-003 trial is a randomized, double-blind, placebo-controlled, multi-center study. Participants are divided into three 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. The high-dose level aligns with the maximum dosage tested in Medicus Pharma’s phase 1 safety study (SKNJCT-001), which concluded in March 2021.

Previous Research and Safety Profile

The earlier phase 1 trial (SKNJCT-001) demonstrated that D-MNA was well tolerated in 13 participants, with no significant safety concerns. Notably, researchers reported 6 participants exhibited complete histological clearance of BCC, all of whom had the nodular subtype. These findings provided the basis for advancing to the current phase 2 study.²

Regulatory Pathway and Future Steps

Medicus Pharma said it plans to submit the interim analysis findings to the US FDA in Q2 2025, seeking a type C meeting to discuss further clinical development. The objective is to align with the FDA on the pathway for potential fast-track designation.

“We seek to secure the FDA’s guidance to the registration pathway for new drug application as we advance our clinical development program. We believe it should 505(b)2 pathway bringing to market a new indication of doxorubicin, which is well studied and is already approved for other cancer therapies,” Bokhari said on the topic. “We also believe we qualify for a fast-track designation by the FDA. We also seek guidance from the FDA on the design of our pivotal trial would be limited to 200-400 patients.”

Additionally, Medicus has proposed a similar clinical study (SKNJCT-004) to the Department of Health in the United Arab Emirates (UAE). This study is expected to randomize 36 patients across four medical institutions, including Cleveland Clinic Abu Dhabi and American Hospital of Dubai.

“BCC is not just an American problem but a global problem; especially in regions where Mohs surgeons are not readily available,” Bokhari stated. “Our clinical study in UAE will be conducted, amongst other clinical sites, at the Cleveland clinic Abu Dhabi and American Hospital in Dubai, complying to comparable protocols accepted by the FDA. We are excited to see our study expand beyond the shores of United States.”

Conclusion

The company stated the interim findings of the SKNJCT-003 study suggest a potentially effective and well-tolerated non-invasive treatment for BCC. While the results are promising, further data from the completed trial will be necessary to confirm these trends. The company’s ongoing regulatory engagements and additional studies in the UAE highlight its commitment to advancing non-invasive treatment options for skin cancer.

“The phase 2 study is ongoing in 9 sites across the United States. We believe that a comprehensive clinical study report covering 60 patients will become available sometime before the end of this year,” Bokhari noted.

References

1. 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/
2. Medicus pharma ltd publishes phase 1 clinical study report demonstrating safety & tolerability in all participants with basal cell carcinoma. News release. Medicus Pharma. Published February 15, 2024. Accessed March 7, 2025. https://medicuspharma.com/medicus-pharma-ltd-publishes-phase-1-clinical-study-report-demonstrating-safety-tolerability-in-all-participants-with-basal-cell-carcinoma/