Medus Pharma宣布FDA获得C类会议的积极反馈;目标是完成第四季度SKNJCT-003招聘和2026年第一季度EOP 2会议

The FDA agrees that the Company may follow 505(b)(2) regulatory pathway to non-invasively treat basal cell carcinoma (BCC) of the skin using dissolvable Doxorubicin-containing Microneedle arrays (D-MNA) representing ~$2 billion in potential market opportunity

The Company plans to complete patient recruitment for SKNJCT-003 before the end of Q4 2025 and to request End-of-Phase 2 (EOP2) with the FDA in Q1 2026

PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / September 29, 2025 / Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce positive feedback from Type C meeting with United States Food and Drug Administration (FDA).

The purpose of the Type C meeting was to discuss the design, endpoints, and other key protocol elements for the clinical development of doxorubicin containing microneedle array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin.

The FDA provided clarity and further alignment that a relative bioavailability study with the Company's D-MNA product to treat BCC administered under certain conditions could provide support towards establishing a clinical bridge for the 505(b)(2) regulatory pathway as well as help satisfy the bioavailability requirement of the Company's D-MNA product as stated in 21CFR320.21. More specifically, the FDA provided positive and constructive feedback on a number of topics for the continued development of Skinject including, but not limited to: the appropriate primary endpoint for the next study; proposed patient population definition, including tumor size limits, location restrictions, and histological confirmation requirements; proposed randomized, double-blind, placebo-controlled, study design for future studies that are intended to demonstrate the effectiveness of D-MNA in treating BCC; and current safety assessments for the proposed study.

In anticipation of future pivotal studies, the FDA also provided recommendations to continue to optimize formulation and microneedle design, integrate an adhesive layer to affix the microneedle system to the body, and incorporate the use of an applicator to consistently apply the product to the application site.

"Establishing 505(b)(2) as a regulatory pathway to bring to market our novel, non-invasive Skinject D-MNA treatment to cure BCC of the skin, is a game changer" stated Dr. Raza Bokhari, Medicus's Executive Chairman & CEO, "by leveraging existing doxorubicin safety data, we will not only realize substantial drug development cost savings but also time savings compared to a traditional full development program. As we plan to complete patient recruitment for SKNJCT-003 before the end this year and request an EOP2 meeting with the FDA in Q1 2026, our confidence is increasing that Skinject may become commercially viable sometime in 2027".

The Company is currently conducting a Phase 2 clinical study for SKNJCT-003 in nine (9) clinical sites across the United States which commenced randomizing patients in August 2024. In March 2025, the Company also announced a positively trending interim analysis for SKNJCT-003 demonstrating more than 60% clinical clearance. The interim analysis was conducted after more than 50% of the then-targeted 60 patients in the study were randomized. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed. In April 2025, the investigational review board approved to increase the number of participants in SKNJCT-003 to ninety (90) subjects. The Company is expanding its trial sites in Europe and has randomized more than 75% of the ninety (90) participants expected to be randomized in the study.

The Company also has a clinical study (SKNJCT-004) currently underway in the United Arab Emirates (UAE). The study is expected to randomize thirty-six (36) patients in six (6) sites in the UAE. Cleveland Clinic Abu Dhabi (CCAD) is the principal investigator, along with Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), Rashid Hospital (RH), Clemenceau Medical Center (CMC) and American Hospital of Dubai (AHD). Insights Research Organization and Solutions (IROS), a UAE-based contract research organization, is coordinating the clinical study for the Company. IROS is a M42 portfolio company.

In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.

Antev's flagship drug candidate is Teverelix trifluoroacetate (Teverelix TFA), a long-acting gonadotrophin-releasing hormone (GnRH) antagonist. Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.