Encouraging Interim Data for Innovative Skin Cancer Patch

By ValueTheMarkets

Mar 07, 2025

5 min read

Medicus Pharma’s SkinJect patch showed promising clinical clearance in Phase 2 interim data. Could this novel treatment be a game-changer in skin cancer care?

Hand in rubber glove handling test tubes of light pink liquid.

Medicus Pharma Ltd. (NASDAQ: MDCX) is delighted to announce a positively trending interim analysis for its SKNJCT-003 Phase 2 clinical study to non-invasively treat basal cell carcinoma (BCC) of the skin1. The interim analysis is extremely encouraging, showing complete clinical clearance of BCC lesions in more than 60% of the participants evaluated so far. The study has already randomized over half of the planned 60 participants.

BCC is the most widespread2 and fastest-growing cancer globally, with U.S. procedures expected to increase by 4% annually, reaching 6 million by 20303. This rising caseload underscores the urgent need for a more effective and scalable solution. With the U.S. market alone representing a $2 billion+ annual opportunity for Medicus Pharma3, its breakthrough treatment could transform how BCC is managed, improving patient outcomes while reducing the burden on healthcare systems.

Medicus Pharma’s Phase 2 study, conducted across nine U.S. clinical sites, is advancing steadily, with more than half of the planned 60 participants already randomized. The encouraging interim analysis represents a key milestone, providing early insights ahead of the full data release. The investigational product, SkinJect’s D-MNA patch, features microneedles that penetrate the skin and dissolve, delivering a chemotherapy agent directly into the cancerous tissue. This targeted approach helps minimize systemic side effects. Importantly, the interim analysis confirms a favorable safety profile at both 100-microgram and 200-microgram doses, with no dose-limiting toxicities or serious adverse events reported. Additionally, there were no significant abnormalities observed in laboratory parameters, vital signs, electrocardiograms, or physical examinations. This is all hugely encouraging for investors in the stock.

Building on these findings, Medicus Pharma plans to submit the interim data to the U.S. Food and Drug Administration (FDA) and request a Type C meeting in the second quarter of 2025. This meeting will allow the company to discuss the clinical development pathway and explore opportunities to accelerate the program. If granted a fast-track designation, the D-MNA patch could move more quickly toward regulatory approval and commercialization.

A faster path to market would shorten the time to potential revenue generation while positioning Medicus Pharma at the forefront of a growing multi-billion-dollar skin cancer treatment market. The strong safety data, combined with a targeted, non-invasive approach, highlights the D-MNA patch’s potential to disrupt traditional treatment methods and capture significant market share. If approved, this innovative therapy could set a new standard in basal cell carcinoma treatment, offering both strong commercial upside and meaningful patient impact.

#Redefining Skin Cancer Treatment

Medicus Pharma’s SKNJCT-003 trial is a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy of the SkinJect D-MNA patch at two dose levels compared to a placebo. Participants are evenly assigned to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100 micrograms of D-MNA, or a high-dose group receiving 200 micrograms of D-MNA.

The 200 microgram dose was previously tested in a Phase 1 safety study (SKNJCT-001) completed in 2021, which confirmed D-MNA was well tolerated with no serious adverse events. In that study, six participants had complete responses, meaning their BCC was fully cleared. All six had the nodular subtype of BCC.

Medicus Pharma’s SkinJect patch is designed as a non-invasive alternative to surgery for basal cell carcinoma (BCC), aiming to shorten recovery time, minimize scarring, and improve accessibility. The patch is painless and easy to administer in a doctor’s office. In fact, the SkinJect patch can be applied during three weekly 30-minute office visits over 2 weeks. By leveraging an innovative microneedle approach, the company is positioning itself as a leader in dermatological oncology, addressing a clear gap in the market with a patient-friendly solution.

#Addressing a Critical Need in BCC Treatment

The rising incidence of basal cell carcinoma3 is driving demand for less invasive treatment options. While Mohs surgery remains the standard, its availability is limited, and traditional surgical methods have cosmetic and functional drawbacks. With over 5 million BCC cases annually and only 870,000 Mohs procedures performed4, and hedgehog inhibitor drugs only used in advanced cases many patients rely on alternative treatments, highlighting the need for more accessible options.

Medicus Pharma’s SkinJect patch aims to fill this void by offering a non-surgical, targeted therapy that could improve patient outcomes while reducing healthcare costs. Beyond the U.S. market, the company has recently submitted its Phase 2 clinical design SKNJCT-004 to the UAE Department of Health5, marking a step toward regulatory review of its non-invasive basal cell carcinoma treatment. This extension of its U.S. Phase 2 study positions it for expansion in regions with rising healthcare investments and growing demand for accessible cancer treatments.

#Paving the Way for a Game-Changing BCC Therapy

These latest interim results mark a major milestone in the development of a novel, non-invasive treatment for BCC.

Medicus Pharma CEO Dr. Raza Bokhari expressed optimism:

“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”.

Interim data shows over 60% complete clinical clearance in the reviewed cohort, indicating positive study trends. To put this in context, even a 20%-25% complete response rate could create a major market opportunity, given the high cost and wait times for Mohs surgery6.

This strengthens confidence in the patch as a potential breakthrough for non-invasive BCC treatment. If final results confirm its efficacy, Medicus Pharma could become a leader in skin cancer therapeutics.

The data also de-risks the company’s clinical program, boosting investor confidence and potential valuation. With plans to engage the FDA in Q2 2025, fast-track approval could accelerate commercialization and revenue. Investors should follow the company's progress, with key milestones ahead:

  • Q2, 2025: Type C FDA meeting could expedite review for its novel, non-invasive BCC therapy.

  • Q3, 2025: Pivotal Trial, expand Phase 2 to between 200 and 400 patients.

  • Q1, 2027: File new drug application with FDA.

If approved, the SkinJect patch could provide patients with a safer, more convenient alternative to surgery, reinforcing Medicus Pharma’s competitive advantage in an expanding multi-billion-dollar market.

#A Breakthrough Worth Watching

  • First-in-class microneedle patch technology: Non-invasive, painless, and cost-effective alternative to Mohs surgery, the current standard of care.

  • Breakthrough treatment option: 5 million+ basal cell carcinoma (BCC) cases diagnosed annually in the U.S.

  • Large market opportunity: Targeting a $15 Billion+ annual market for BCC treatment.

  • Phase 2 trial progress: Over 50% of patients enrolled; positive interim data with 60% complete clinical clearance of the BCC lesions.

  • Regulatory pathway advantage: Potential FDA Fast-Track designation.

  • Strong financial position: No long-term debt, $16M raised in 2024, sufficient cash for Phase 2 completion.

  • Analyst confidence: Share price targets of $10 (Maxim Group) and $12 (Brookline Capital)4 - 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).

  • IP Protection: University-developed technology with patents secured through 2035.

#About Medicus Pharma

Medicus Pharma Ltd. (NASDAQ: MDCX) is a biotech and life sciences company focused on advancing novel therapeutic assets through clinical development and commercialization. Its wholly owned subsidiary, SkinJect, is developing a dissolvable microneedle patch to treat basal cell carcinoma (BCC), the most common skin cancer worldwide. With clinical patents secured through 2035 and a Phase 2 trial underway, Medicus aims to expand its pipeline through acquisitions and partnerships.

Explore the Medicus Pharma Story in Detail

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