San Francisco, June 12, 2019 – OKAVA Pharmaceuticals, Inc., a clinical stage research and development company focused on diseases of aging in dogs and cats, today announced that the company had a successful and encouraging pre-submission conference (PSC) with the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) regarding development of OKV-1001.

OKAVA requested the meeting to obtain the FDA’s feedback on the planned clinical development program for the company’s veterinary immunomodulating candidate OKV-1001 (modified release mycophenolate) with the intention to pursue full approval in the US. On a high level, the FDA agreed to OKAVA’s development strategies. The strategy is to perform a pilot study, to evaluate OKV-1001 in dogs with immune-mediated hemolytic anemia (IMHA), which is to be followed by a pivotal study. OKAVA plans to start the pilot study in the second half of 2021.

“We are encouraged by this successful pre-submission meeting with the FDA regarding OKV-1001” said Michael Klotsman, CEO of OKAVA. “There are no approved treatment options for dogs with IMHA, a condition that results in death in up to half of dogs diagnosed with this debilitating disease. Our plan to start clinical development of OKV-1001 is a critical first step to advancing this drug and expanding treatment options in this market.”

The company received advice on major technical sections Chemistry Manufacturing and Controls (CMC), Target Animal Safety (TAS), and Effectiveness. OKAVA has received MUMS (Minor Use/Minor Species) designation for OKV-1001.