PHILADELPHIA, PA — May 6, 2026 — Leads & Copy — Medicus Pharma Ltd. (NASDAQ: MDCX) has announced positive results from an expanded dataset analysis of its Phase 2 SKNJCT-003 study, which evaluated the safety and efficacy of Doxorubicin Microneedle Array (D-MNA) for treating nodular basal cell carcinoma (BCC) of the skin.
The analysis demonstrated a positive dose response, building upon previously reported topline results. The additional analysis provides expanded biological, histologic, and safety insights.
Dr. Raza Bokhari, Chairman and CEO of Medicus, stated that the findings strengthen the clinical and regulatory foundation of the SKNJCT-003 Program and move the company from proof-of-concept to a clear registrational path.
The findings are consistent with prior Phase 1 clinical observations in the SKNJCT-001 study in March 2021, and interim analysis of SKNJCT-003 in March 2025.
The SKNJCT-003 clinical study (NCT06608238) was a randomized, double-blind, three-arm Phase 2 study evaluating two dose levels of microneedle-mediated delivery of doxorubicin compared with a device-only control in patients with nodular basal cell carcinoma. The multi-center study was designed to enroll 90 participants presenting with nodular type basal cell carcinoma, who were randomized 1:1:1 into three groups:
Device-controlled group receiving P-MNA
Low-dose group receiving 100µg of D-MNA
High-dose group receiving 200µg of D-MNA
Expanded central pathology reconciliation demonstrated that 69 participants met intended nodular BCC inclusion criteria, while 21 participants were identified as superficial or mixed subtype lesions.
The expanded analysis of the 69 participants demonstrated a progressive and dose-dependent improvement, with the strongest separation emerging at Day 57.
The topline dataset showed that:
The 200µg cohort achieved the highest observed activity at Day 57
Clearance rates improved from Day 29 to Day 57, consistent with continued biological activity over time
The pre-specified expanded dataset analysis builds on this foundation by:
Revealing a clear and consistent dose-response relationship across endpoints
Demonstrating stronger separation between the 200µg cohort and control, particularly at Day 57
Strengthens differentiation between drug-driven efficacy and device-only biological activity
The 200µg cohort at Day 57 emerged as the leading dose with the most robust and consistent efficacy signal.
According to Medicus Pharma, the findings suggest that many treated lesions may in the future be able to avoid immediate surgical intervention. The company also stated that D-MNA continued to demonstrate a favorable safety and tolerability profile, with no drug-related serious adverse events or evidence of systemic doxorubicin toxicity.
The device-only arm demonstrated early biological activity, but it did not show sustained or deepening efficacy over time. The 200µg D-MNA cohort demonstrated progressive improvement from Day 29 to Day 57, resulting in clear separation across both clinical and histological endpoints.
Dr. Babar K. Rao, MD, FAAD, Principal Investigator of the SKNJCT-003 study, believes the dataset demonstrates a clinically meaningful rapid onset efficacy, clear differentiation between drug and device effect and a profile that supports continued development and regulatory progress. Dr. Rao noted the consistency between visual, histologic, and central pathology findings is highly encouraging and provides growing confidence that SkinJect® is producing meaningful biologic anti-tumor effects.
Medicus Pharma Ltd. is focused on accelerating the clinical development programs of therapeutics assets. The company is engaged in multiple countries across three continents.
The company’s key therapeutics assets are:
SkinJect™, a localized immuno-oncology precision product focused on non-melanoma skin diseases.
Teverelix®, a next generation GnRH antagonist for cardiovascular high-risk advanced prostate cancer patients and patients with acute urinary retention relapse.
Medicus Pharma is also engaged in collaborations including one with Helix Nanotechnologies, Inc. for the co-development of thermostable infectious disease vaccines, a strategic collaboration with the Gorlin Syndrome Alliance to advance compassionate access to SkinJect for patients suffering from Gorlin Syndrome, and a collaboration with Reliant AI Inc. to develop an AI-driven clinical data analytics platform.
Source: Medicus Pharma Ltd.
