Medicus Pharma Completes Phase 2 Enrollment for Novel Microneedle Basal Cell Carcinoma Treatment
核心洞察
Medicus Pharma has successfully enrolled 90 patients in its Phase 2 SKNJCT-003 trial evaluating a doxorubicin microneedle array for non-invasive treatment of nodular basal cell carcinoma (搜索).
The randomized, double-blind, placebo-controlled study compares two dose levels of the investigational treatment across nine clinical sites in the United States.
Interim analysis from March 2025 showed more than 60% clinical clearance in 26 patients, with topline results expected in Q1 2026.
Medicus Pharma Ltd (搜索). (NASDAQ: MDCX) has completed enrollment of 90 patients in its Phase 2 clinical trial evaluating a novel microneedle array system for treating basal cell carcinoma (搜索) (BCC) of the skin. The SKNJCT-003 study represents a significant milestone in developing what could become the first non-invasive treatment option for this common skin cancer.
The Philadelphia-based biotech company announced that its doxorubicin microneedle array (D-MNA) technology has reached full enrollment across nine clinical sites in the United States. The company expects to release topline results in the first quarter of 2026 and secure an end-of-phase 2 meeting with the FDA in the first half of 2026.
Promising Interim Results Drive Optimism
Dr. Raza Bokhari, Medicus's Executive Chairman and CEO, expressed confidence in the treatment's potential, citing encouraging preliminary data. "We are very hopeful that the clinical study report expected in H1 2026 will reaffirm the positively trending preliminary interim data analysis that the Company released earlier this year in Q1 2025 which showed more than 60% clinical clearance in 26 patients," Bokhari stated.
The interim analysis was conducted after more than 50% of the then-targeted 60 patients were randomized, though the company notes these findings are preliminary and may not correlate with final study results.
Innovative Trial Design and Dosing Strategy
The SKNJCT-003 study employs a randomized, double-blind, placebo-controlled design with participants allocated 1:1:1 across three treatment arms. Patients receive either a placebo microneedle array (P-MNA), a low-dose 100μg D-MNA, or a high-dose 200μg D-MNA treatment.
The maximum 200μg dose was previously validated in the company's Phase 1 safety study (SKNJCT-001), completed in March 2021. That earlier trial enrolled 13 participants and met its primary safety and tolerability objectives, with no dose-limiting toxicities or serious adverse events reported. Notably, six participants achieved complete responses, defined as histological disappearance of BCC in the final excision.
Strong Safety Profile Established
The Phase 1 study demonstrated that D-MNA was well tolerated across all dose levels, with no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, or physical examinations. All six participants who achieved complete responses had the nodular subtype of BCC, representing a diverse patient profile.
Regulatory Pathway and Market Opportunity
In September 2025, Medicus received positive feedback from the FDA regarding its Type C meeting, indicating the company may follow the FDA's 505(b)(2) regulatory pathway for developing the non-invasive BCC treatment. This pathway could potentially expedite the approval process by leveraging existing safety and efficacy data.
Bokhari emphasized the commercial potential, stating the treatment "represents ~$2 billion in potential market opportunity" as a "non-invasive, patient friendly, cost effective, localized immune therapy to treat basal cell carcinoma (搜索) of the skin."
Global Expansion and Strategic Partnerships
The company has expanded its clinical program internationally, receiving full regulatory and ethical approvals in the United Kingdom in November 2025 from the Medicines and Healthcare products Regulatory Agency (MHRA), Health Research Authority (HRA), and Wales Research Ethics Committee (WREC). Additionally, a separate Phase 2 study (SKNJCT-004) is underway in the United Arab Emirates, expected to randomize 36 patients across six sites with Cleveland Clinic Abu Dhabi as the principal investigator.
Medicus has also established a strategic collaboration with the Gorlin Syndrome Alliance (搜索) to advance compassionate access to SkinJect (搜索) for patients with Gorlin Syndrome (搜索), also known as nevoid basal cell carcinoma syndrome (搜索). This partnership aims to pursue an Expanded Access IND Program with the FDA for patients with multiple, recurrent, or inoperable BCCs.
Broader Pipeline Development
Beyond its skin cancer program, Medicus completed the acquisition of Antev Limited (搜索) in August 2025, adding Teverelix, a next-generation GnRH antagonist for cardiovascular high-risk advanced prostate cancer (搜索) patients. The company also entered a memorandum of understanding with Helix Nanotechnologies (搜索) to explore co-development of thermostable infectious disease vaccines using its microneedle platform.