Medicus Pharma (NASDAQ:MDCX) said on Monday it has submitted a comprehensive product development plan to the US Food and Drug Administration (FDA) to advance its investigational treatment for external squamous cell carcinoma (SCC) in horses.
The plan was submitted under the company’s existing Investigational New Animal Drug file and follows the FDA’s Minor Use in Major Species designation, which Medicus received in December 2024 for its dissolvable doxorubicin-containing microneedle array (D-MNA).
The designation, similar to orphan drug status for human therapies, entitles Medicus to seven years of exclusive marketing rights upon product approval, provided regulatory requirements are met.
The company’s D-MNA therapy uses cellulose-based microneedles that dissolve after penetrating the skin and tumor site, releasing the chemotherapy drug doxorubicin directly into the cancerous tissue.
“In veterinary medicine, where only a few oncology drugs are approved, we believe a non-invasive treatment for equine SCC represents an unmet market opportunity potentially worth $250 million,” said Dr Raza Bokhari, Executive Chairman and CEO of Medicus. "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."
The planned clinical study, SKNJCT-004, will be a randomized, double-blind, placebo-controlled, multi-center trial enrolling up to 50 horses with external SCC. Participants will be assigned to one of three groups: placebo, low-dose (100μg D-MNA), or high-dose (200μg D-MNA), with outcomes evaluated over six months. The primary endpoint will be the complete clinical response of the target tumor at day 90, as assessed by a veterinarian using RECIST criteria.
The 200μg high dose proposed in the equine study was previously evaluated in a Phase 1 human safety study completed in March 2021 and met its safety and tolerability goals.