Medicus Pharma (NASDAQ:MDCX, TSX-V:MDCX) announced that the Food and Drug Administration has granted Minor Use in Major Species (MUMS) designation for its Investigational New Animal Drug, a dissolvable Doxorubicin-containing microneedle array (D-MNA) patch targeting external squamous cell carcinoma in horses.
The MUMS designation, akin to the Orphan Drug status for human medicine, provides Medicus with a seven-year exclusive marketing period following product approval or conditional approval, contingent on meeting the program's requirements.
The company’s D-MNA patch is a patented transdermal treatment using cellulose-based microneedles tip-loaded with doxorubicin. Upon application, the microneedles create microchannels in the skin to deliver the drug directly into tumors, targeting and eradicating cancer cells.
Squamous cell carcinoma (SCC) primarily affects adult or aged horses with white or partially white coats, often occurring in minimally pigmented areas like the eyes, lips, or nose.
Current treatments include surgery, cryotherapy, chemotherapy injections, and topical or oral drugs.
Medicus aims to offer a non-invasive alternative to existing treatment options, Medicus CEO Dr Raza Bokhari highlighted.
“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,” Bokhari said.
“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.”