Interim data from Medicus Pharma’s skin cancer program showed more than 60% clinical clearance in the first 26 randomized patients in its ongoing Phase 2 study of a doxorubicin microneedle array (D-MNA) for nodular basal cell carcinoma (BCC), following a Phase 1 safety study in 13 participants that reported no serious adverse events and six histologic complete responses at excision. The Phase 2 design randomizes patients 1:1:1 to placebo microneedle, 100 μg D-MNA, or 200 μg D-MNA, with histologic clearance as the key readout.
The core update is operational: Medicus has completed U.S. enrollment of 90 patients across nine sites for SKNJCT-003, set topline data for Q1 2026, and plans an End-of-Phase 2 meeting with FDA in H1 2026. The company has MHRA, HRA, and WREC approvals to expand the study footprint into the United Kingdom, and it initiated a separate 36-patient, six-site randomized study (SKNJCT-004) in the United Arab Emirates, coordinated by IROS with Cleveland Clinic Abu Dhabi as the PI site. FDA Type C feedback indicates D-MNA may proceed via a 505(b)(2) pathway, leveraging doxorubicin’s prior safety knowledge while assessing the novel microneedle delivery system.
Strategically, Medicus is pursuing a de-risked regulatory route in a large, procedure-dominated market. A localized cytotoxic patch directly competes with standard excision and Mohs surgery, topical agents, and destructive modalities. The 505(b)(2) signal suggests the focus will be on local tolerability, device-drug performance, and durable histologic clearance rather than systemic safety, with combination product coordination likely to shape CMC and human factors expectations. UK authorization broadens regulatory dialogue and may position the program for future multi-region registration planning, while the UAE trial extends operational breadth and supports external validation of site training and procedure reproducibility.
For sites, this is a dermatology-friendly model that could shift certain BCC cases from the OR to the clinic if efficacy and recurrence data hold, with implications for staffing, scheduling, and pathology workflows. The protocol’s end-of-study excision to confirm histologic outcomes imposes logistics around specimen processing and central reads; success here would ease future adoption. CROs and vendors should anticipate device accountability, chain-of-custody, and microneedle application training to be central. Regulators will likely scrutinize dose-response, margin-negative equivalence to surgery in appropriate risk classes, cosmetic outcomes, and 6–12 month recurrence. The Gorlin Syndrome expanded access collaboration aims to seed real-world safety and usability data in a high-need subpopulation, potentially informing label strategy and payer discussions.
The next inflection comes with Q1 2026 topline data. Beyond headline clearance rates, durability, blinded histologic confirmation, and a clear dose gradient will determine whether SKNJCT-003 can support a pivotal pivot or require another efficacy study. Comparator strategy for Phase 3 remains an open question: surgery, an active topical, or risk-stratified designs could shape regulatory and commercial trajectories. Manufacturing scale-up of consistent microneedle arrays and combination product quality controls will be gating factors. Watch for EOP2 feedback on endpoint selection, recurrence follow-up requirements, and human factors validation. Also worth monitoring is portfolio focus: recent moves into prostate cancer (Antev) and a non-binding mRNA MoU add optionality but could dilute execution unless the skin franchise advances decisively on its 2026 timeline.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
