Dr. Raza Bokhari reports

MEDICUS PHARMA LTD. ANNOUNCES MINOR USE (MUMS) DESIGNATION FROM THE FDA FOR DOXORUBICIN-CONTAINING MICRONEEDLE ARRAY (D-MNA) PATCH

Medicus Pharma Ltd.'s investigational new animal drug (INAD file No. 013880) has received minor use in major species designation (MUMS) from the United States Food and Drug Administration (FDA) for its dissolvable Doxorubin-containing microneedle array (D-MNA) to treat external squamous cell carcinoma (SCC) in horses. The company received a notification from the FDA on Dec. 9, 2024.

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

"In a relatively short period of time, we have made remarkable progress with the FDA in advancing the clinical development program of the veterinary application of our novel D-MNA patch in treating SCC in horses," stated Dr. Raza Bokhari, executive chairman and chief executive officer. "Developing a non-invasive treatment for equine SCC represents an untapped market opportunity that we are excited to pursue. The MUMS designation is an important catalyst to provide us a first-mover advantage and also position us to possibly have a commercially viable product as early as 2026."

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 tumour, dissolve and release doxorubicin into the target tumour, and eradicate the cancer cells.

Squamous cell carcinoma (SCC) in horses

SCC is a mucocutaneous skin tumour 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, tumours are mainly seen around the eyes, lips, nose, anus and external genitalia. The overall incidence of SCC is 2 to 3 per cent and recent estimates of the United States horse population range from 6.6 million 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 (tumours near the eye) or cream (tumours 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.

About Medicus Pharma Ltd.

Medicus is a biotech/life science company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets.

SkinJect Inc., a wholly owned subsidiary of Medicus, is a development-stage, life science company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumour cells. The company has completed a phase 1 safety and tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six participants experiencing complete response on histological examination of the resected lesion. The company submitted a phase 2 investigational new drug clinical protocol to the FDA in January, 2024, for a randomized, controlled, double-blind, multicentre clinical study (SKNJCT-003) that is expected to randomize up to 60 patients. The study is designed to evaluate the efficacy of two doses of two-dose levels (100 and 200 micrograms) of D-MNA compared with placebo (P-MNA) in subjects with nodular BCC. Patient recruitment is currently under way in nine sites across the United States.

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