FAQs on Medicus Pharma's Interim Data Update - 6 March 2025

By Mark Sheridan

Mar 06, 2025

4 min read

Medicus Pharma reports a positive trend in its interim Phase 2 trial analysis for a novel skin cancer treatment. Here are FAQs explaining this breakthrough.

Medicus Pharma Reports Positive Trial Data

Medicus Pharma Ltd. (NASDAQ: MDCX) has reported1 encouraging interim analysis from its latest clinical trial, SKNJCT-003 Phase 2, highlighting positive progress in non-invasively treating basal cell carcinoma (BCC) of the skin. The interim data released today demonstrated complete clinical clearance of more than 60% in the cohort of participants reviewed, indicating a positive trend in the study and reinforcing optimism about the treatment’s potential.

The SKNJCT-003 clinical study is making excellent progress across nine sites in the United States, with a target to enroll 60 patients. With over half of the target group already randomized, this strongly positive interim analysis has now been completed, marking a key milestone in the study’s advancement.

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#Frequently Asked Questions (FAQs)

Company and Study Overview

1. What is Medicus Pharma Ltd. developing?

Through its subsidiary SkinJect, Medicus Pharma Ltd. is advancing a non-invasive treatment for basal cell carcinoma (BCC). Its investigational product, D-MNA is a first-in-class, non-invasive microneedle patch designed to revolutionize BCC treatment. The ongoing SKNJCT-003 Phase 2 clinical study in the United States evaluates the efficacy and safety of this treatment.

2. What is the significance of the interim analysis?

The interim analysis indicates a positive trend, with more than 60% of treated patients achieving complete clinical clearance of BCC. It also confirms that the SkinJect D-MNA patch is well tolerated at both dose levels without serious adverse events or systemic effects.

This provides an early indicator of the SkinJect D-MNA patch’s potential as a breakthrough treatment for basal cell carcinoma (BCC). A 60% complete clinical clearance rate suggests strong efficacy, which, if confirmed in final trial results, could position Medicus Pharma as a leader in non-invasive skin cancer treatments.

It also represents a key milestone that de-risks the company's clinical development program. Positive interim data can increase investor confidence, attract institutional interest, and potentially enhance the company’s valuation.

Additionally, the company’s plan to engage with the FDA for regulatory alignment in Q2 2025 signals a clear development pathway. If the FDA grants fast-track status, it could shorten the timeline to commercialization, accelerating revenue potential.

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3. How does the SKNJCT-003 study work?

This is a randomized, double-blind, placebo-controlled, multi-center study involving 60 patients. It is currently underway in nine (9) clinical sites across the United States. Participants are divided into three groups: one receiving a placebo (P-MNA), one receiving 100 micrograms of D-MNA, and one receiving 200 micrograms of D-MNA.

#Investor and Market Impact

4. Why is this interim analysis important for investors?

The results support the potential for the SkinJect D-MNA patch as a breakthrough non-invasive therapy for BCC. Strong clinical data could lead to regulatory alignment, fast-track development, and increased market potential.

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5. How large is the market for BCC treatments?

Basal cell carcinoma is the most common type of skin cancer, with millions of cases diagnosed annually. Existing treatments are invasive, making a non-invasive alternative a significant opportunity.

6. What are the competitive advantages of the SkinJect D-MNA patch?

The SkinJect D-MNA patch aims to offer a non-surgical treatment option for BCC, reducing patient discomfort and healthcare costs. If successful, it could become a preferred alternative to traditional surgical methods.

Regulatory and Development Pathway

7. What are the next regulatory steps?

Medicus Pharma plans to submit the interim analysis to the FDA and request a Type C meeting in Q2 2025 to discuss the clinical development pathway and potential fast-tracking of the program.

8. What does a Type C meeting with the FDA mean?

A Type C meeting provides an opportunity for Medicus Pharma to discuss development plans with the FDA and seek guidance on regulatory strategy, which could help accelerate approval timelines.

Clinical and Safety Profile

9. What are the safety findings from the study?

The SkinJect D-MNA patch has been well tolerated at both dose levels, with no dose-limiting toxicities, serious adverse events, or systemic side effects observed in the study so far.

10. How does this study compare to previous trials?

The Phase 1 SKNJCT-001 study, completed in March 2021, demonstrated safety and tolerability, with six participants achieving complete BCC clearance. These results laid the foundation for the current Phase 2 trial.

#Expansion and Future Plans

11. Is Medicus Pharma expanding its clinical studies internationally?

Yes, the company has submitted a clinical design (SKNJCT-004) to the UAE Department of Health. This study will randomize 36 patients across four major medical centers in the UAE.

12. What are the long-term goals for the SkinJect D-MNA patch?

Medicus Pharma aims to complete Phase 2 trials, secure FDA alignment for further development, and position the SkinJect D-MNA patch as a commercially viable non-invasive treatment for BCC.

13. When can investors expect the next update?

The company will provide further updates following the Type C meeting with the FDA in Q2 2025 and as additional trial milestones are achieved.

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