Medicus Pharma Provides Additional Phase 2 Data for SkinJect Cancer Therapy

Why It Matters

The therapy promises to replace invasive Mohs surgery for most basal cell carcinoma patients, creating a sizable market shift and reducing healthcare costs, while accelerating Medicus Pharma’s path to commercialization.

Key Takeaways

• Phase 2 shows 75% avoid Mohs surgery in patients
• 200 µg microneedle cohort achieved 73% visual clearance at day 57
• Active microneedle placebo demonstrates inherent biological activity in treatment
• FDA end‑of‑phase‑2 meeting slated for mid‑2024 to discuss pivotal study
• Company seeks strategic partner for co‑development and commercialization

Summary

Medicus Pharma presented additional Phase 2 results for its SkinJect microneedle therapy, aimed at treating basal cell carcinoma without surgery. The data, discussed by CEO Dr. Raza Bokhari, focus on a non‑invasive approach that could alleviate the roughly one‑million annual Mohs procedures performed in the United States.

In the 200‑microgram cohort, 73% of lesions showed visual clearance by day 57, and three out of four patients were unlikely to require subsequent Mohs surgery. The trial also featured an active placebo—microneedle arrays without doxorubicin—that exhibited modest biological activity, underscoring the platform’s intrinsic therapeutic effect. Histological clearance differences were narrower, leaving the FDA to define acceptable thresholds.

Dr. Bokhari highlighted the significance, stating, “Three out of four treated patients would not need Mohs surgery… this is a blockbuster in the making.” He also emphasized the patented microneedle composition and the strategic timing of an end‑of‑Phase 2 meeting with the FDA, expected by mid‑2024.

If the FDA grants favorable guidance, SkinJect could dramatically reduce surgical backlogs, cut patient morbidity, and open a sizable market for non‑surgical skin cancer treatment. The company is already courting strategic partners to co‑develop and commercialize the therapy, positioning itself for rapid scale‑up.

Original Description

Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to provide additional details from the company’s Phase 2 clinical study (SKNJCT-003) evaluating the safety and efficacy of its Doxorubicin Microneedle Array (D-MNA) for the non-invasive treatment of Basal Cell Carcinoma.

The data showed the strongest treatment response in the 200-microgram cohort, which achieved 73% clinical clearance and 40% histological clearance at Day 57. The results highlight the therapeutic potential of the company’s SkinJect platform, which uses microneedle technology to deliver chemotherapy directly into skin lesions without surgery.

According to Medicus Pharma, the findings are particularly notable given the device-based mechanism of SkinJect. The microneedle delivery process itself may produce biological activity, which can contribute to responses even in the placebo arm of the trial. In this study, the placebo microneedle array (P-MNA) was not tip-loaded with the chemotherapeutic agent but could still stimulate a biological response due to the mechanical action of the device.

The company noted that active placebo arms are not uncommon in device-drug combination trials and can be considered an acceptable regulatory data point. Importantly, the results demonstrated a clear separation in treatment response between the D-MNA therapy arm and the placebo microneedle arm in the 200-µg cohort, with clinical clearance rates of 73% and 38% respectively.

Management believes the dataset represents decision-grade evidence supporting the continued advancement of the SkinJect program as a potential non-surgical treatment option for patients with basal cell carcinoma. The company plans to move forward with an End-of-Phase-2 meeting with the U.S. Food and Drug Administration to determine the optimal registrational development pathway and explore.

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