Medicus Pharma (NASDAQ:MDCX) earlier this week announced the submission of a veterinary clinical development program to the FDA targeting squamous cell carcinoma in horses.
The move follows the company’s receipt of an orphan drug designation for the condition from the veterinary division of the agency.
The company told investors that this program marks its entry into veterinary oncology. It said the disease, which often presents under the eyelids of aging horses, is currently treated via surgery — an approach that is frequently impractical. Medicus highlighted that its noninvasive microneedle array technology could offer a viable alternative.
The platform is already in use for a 90-patient Phase II trial for human skin cancer, which includes a study site at Cleveland Clinic Abu Dhabi. Medicus said the same technology is being repurposed for animals, representing a new market opportunity it estimated at around US$250 million.
CEO Raza Bokhari said the study design was guided by minutes from a pre-IND meeting with the FDA. He explained that a 30-day period is now in effect, after which the study could begin if no further input is received. Up to 50 horses are expected to be enrolled in the trial.
Bokhari also updated on company finances. He said Medicus had raised about US$35 million, including US$4 million of his own capital. He added that the company was well-positioned to advance its development programs without requiring further major dilutive funding.