Medicus Pharma Ltd. Announces Submission Of Product Development Plan To The Food And Drug Administration (FDA) To Treat External Squamous Cell Carcinoma (SCC) In Horses

(MENAFN- Newsfile Corp) Philadelphia, Pennsylvania--(Newsfile Corp. - June 9, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce submission of a comprehensive product development plan to treat external squamous cell carcinoma (SCC) under Investigational New Animal Drug (INAD File No.013880).

The Company, in December 2024, received a Minor Use in Major Species Designation (MUMS) for its dissolvable Doxorubin-containing microneedle array (D-MNA) to treat external squamous cell carcinoma (SCC) in horses. The product development plan is designed to seek concurrence of the FDA under MUMS designation.

MUMS is a status similar to Orphan Drug status for human drugs. It entitles the Company to an extended 7-year period of exclusive marketing following approval or conditional approval, provided that the Company meets all requirements for maintaining the designation.

Doxorubicin-containing microneedle array (D-MNA) is a patent protected dissovable transdermal patch with cellulose based microneedle arrays that are tip-loaded with doxorubicin. After application, the microneedles function by penetrating the strateum corneum layer of the skin, create a temporary microchannel, penetrate the tumor, dissolve and release doxorubicin into the target tumor, and eradicate the cancer cells.

"In Veterinary Medicine, where there are only a handful of approved oncology drugs, we believe developing a non-invasive treatment for equine SCC represents an untapped and unmet market opportunity potentially in the range of $250 million," stated Dr. Raza Bokhari, Executive Chairman & CEO. "The submission to the FDA of a novel product development program may provide us a first mover advantage and sets the stage to consider other companion animal species and types of cancer."

Squamous Cell Carcinoma (SCC) in Horses

SCC is a mucocutaneous skin tumor in horses, primarily affecting adult or aged horses with white or partially white coats. Breeds like Appaloosa, Belgian, American Paint, and Pinto are particularly susceptible. SCC often develops in areas with minimal pigmentation and sparse hair, notably around mucous membranes. More specifically, tumors are mainly seen around the eyes, lips, nose, anus, and external genitalia. The overall incidence of SCC is 2-3% and recent estimates of the US horse population range from 6.6 to 7.25 million horses.

Current treatment includes surgery to remove the largest mass, cryotherapy of the smaller mass, and local injection of a chemotherapy drug. In some cases, a topical chemotherapeutic drug will be prescribed in the form of drops (tumors near the eye) or cream (tumors in other parts of body). Additionally, some horses are put on an oral drug called piroxicam that may slow the return of the cancerous cells.

Product Development Plan

The clinical study, SKNJCT-004, is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 50 horses presenting with external SCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to a placebo control. The horses will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA. The horses will be assessed for outcomes over six (6) months from index dose. The primary effectiveness variable will be a veterinarian's assessment for complete clinical response of the target tumor at day 90 according to RECIST.

The high-dose, 200μg D-MNA, proposed in the study is the maximum dose that was used in the Company's Phase 1 safety and tolerability human study (SKNJCT-001) completed in March 2021.

SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA, was well tolerated across all dose levels in all 13 participants enrolled in the study, with no dose-limiting toxicities (DLTs), or serious adverse events (SAEs). Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The study also describes the efficacy of the investigational product, D-MNA, with 6 participants experiencing complete responses. The complete response is defined as the disappearance of BCC histologically in the final excision at the end of study visit. The participants profile demonstrating complete responses was diverse, and all participants (6/6) had nodular subtype of BCC.

The Company also has SKNJCT-003 Phase 2 clinical study currently underway in nine (9) clinical sites across 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 the 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 increased the number of participants in SKNJCT-003 to Ninety (90) subjects. The Company also announced expanding clinical trial sites in Europe.

The Company also has a clinical design (SKNJCT-004) currently underway in United Arab Emirates (UAE). The study is expected to randomize 36 patients in four sites in UAE. Cleveland Clinic Abu Dhabi (CCAD) is the principal investigator, along with Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), 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 April 2025, the Company announced entering into a binding letter of intent to acquire Antev Ltd. (" Antev "), a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as 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.

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