PharmAust (ASX:PAA) has announced positive top-line data from its Phase 2 veterinary clinical study of monepantel (MPL) for the treatment of canine B-Cell lymphoma.
The company said it plans to use this data to open an Investigational New Animal Drug (INAD) application with the US FDA Center for Veterinary Medicine (CVM) and proceed with pivotal studies in 2024 to support product registration.
CEO Dr Michael Thurn said, “The potential for PharmAust to achieve a major value inflexion point by advancing MPL through to product registration with the Center of Veterinary Medicine makes good business sense.
"The minor investment to conduct the pivotal registration studies could release significant shareholder value through receiving conditional approval for MPL from the CVM. LAVERDIA, the most recently approved treatment for B-cell and T-Cell Lymphoma, was acquired by Dechra Pharmaceuticals for US$64.5 million in 2022.
"As our MPL tablet has a comparable efficacy profile to LAVERDIA and offers significant advantages in quality of life and safety for both the dog and the owner, we are confident in the commercialisation of MPL for canine cancer.”
This company said the Phase 2, open-label, single-arm, dose-finding study was conducted at nine sites in Australia, New Zealand, and the US. Its objective was to determine a clinically safe and efficacious dose of MPL for the treatment of dogs with B-cell lymphoma whilst maintaining quality of life (QoL).
Dogs received a once-daily treatment of MPL at home for 28 days.
The company said that overall the treatment was regarded as safe and well-tolerated. Of the 40 dogs evaluable for efficacy, partial response to treatment was observed in two dogs, stable disease in 12, and progressive disease in 26. None of the dogs in this study achieved a complete response. The overall response rate was achieved in two.