Interim Data Update from Medicus Pharma’s Phase 2 Clinical Trial

By Mark Sheridan

Mar 06, 2025

3 min read

Medicus Pharma reports a positive trend in its interim Phase 2 trial analysis for a revolutionary skin cancer treatment. Key details on this major 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.

Medicus Pharma’s Executive Chairman & CEO is thrilled with the trial’s progress:

“We are immensely encouraged by the positively trending interim analysis. This brings us one step closer to delivering a novel, non-invasive treatment for BCC”.

BCC is the most common2 and fastest-growing cancer globally, with U.S. procedures projected to grow at 4% annually, reaching 6 million by 20303. This expansion represents a $2B+ annual market opportunity in the U.S. alone.

Medicus Pharma’s non-invasive SkinJect microneedle patch is designed to provide a non-invasive treatment for basal cell carcinoma, a condition that currently requires surgical intervention in most cases3.

The company’s reassuring interim analysis also shows the investigational product, D-MNA was well tolerated for both dose levels trialed. This includes a low-dose group receiving 100 micrograms of D-MNA and a high-dose group receiving 200 micrograms of D-MNA. In all participants so far enrolled in the study, the results show no dose-limiting toxicities (DLTs) or serious adverse events (SAEs). Additionally, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examination. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed.

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The Company intends to submit its interim analysis results to the United States Food and Drug Administration (FDA) as part of a package seeking a Type C meeting with the FDA in Q2 2025. Securing a Type C meeting would be a significant milestone in the Phase 2 trial, providing the company with a formal platform to discuss product development and refine its clinical strategy with regulatory input. The company's ultimate goal is to secure FDA consent to accelerate its clinical development program.

The randomized, double-blind, placebo-controlled study divides participants into 3 groups: a placebo group, a low-dose group receiving 100 micrograms of D-MNA, and a high-dose group receiving 200 micrograms of D-MNA—the maximum dose previously tested in a Phase 1 study.

The earlier trial, SKNJCT-001, completed in March 2021, successfully met its primary goal of demonstrating safety and tolerability, paving the way for this next phase of development.

Incidentally, the company has also submitted a request to expand its Phase 2 trial in the UAE4. Its submission to the UAE Department of Health marks an important step in gaining regulatory approval and market entry in a high-growth region.

Investors will be watching closely as the company advances its clinical program, aiming to bring an innovative skin cancer treatment to market.

To discover the Full Potential of Medicus Pharma – Read our In-Depth Report Now!

#Why is this Important to Retail Investors?

  • First-in-Class Microneedle Patch Technology: Non-invasive, painless, and cost-effective alternative to Mohs surgery, the current standard of care.

  • Encouraging Clinical Results: Interim analysis shows over 60% complete clinical clearance, reinforcing optimism about Medicus Pharma’s non-invasive treatment approach.

  • Strong Market Potential: Basal cell carcinoma (BCC) is the most common2 and fastest-growing cancer worldwide. Medicus is targeting a $7B+ annual market for BCC treatment.

  • Regulatory Milestones Ahead: The company plans to submit results to the FDA for a Type C meeting, a crucial step toward securing regulatory alignment and accelerating development.

  • Expansion into High-Growth Markets: A request to expand the Phase 2 trial to the UAE signals potential for international market entry, broadening future revenue opportunities.

  • Proven Safety Profile: With no dose-limiting toxicities or serious adverse events reported, the company has a strong safety foundation from its previous Phase 1 trial, increasing confidence in its clinical progress.

  • Analyst confidence: Share price targets of $10 (Maxim Group) and $12 (Brookline Capital)5 - more than 240% to 300% upside based on a $2.90 closing price on 4 March 2025.
    (Note: Analyst targets are based on projections and assumptions that may not materialize).

To discover the Full Potential of Medicus Pharma – Read our In-Depth Report Now!

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