OKAVA Awarded $500,000 Grant by the FDA for Clinical Trial of OKV-1001 for the Treatment Blood Disorder

The Competitive Grant Awarded to OKAVA Demonstrates That the FDA Considers OKV-1001 To Be an Innovative Product That Addresses High Unmet Medical Need

San Francisco, California – May 5, 2020 – OKAVA Pharmaceuticals, Inc., a clinical stage research and development company focused on diseases of aging in dogs and cats, today announced that the company was awarded a $500,000 grant to continue research for the use of OKV-1001 (modified release mycophenolate) for the treatment of canine immune-mediated hemolytic anemia (IMHA).

The grant was received from the U.S. Food and Drug Administration as part of the agency’s Minor Use/Minor Species program, developed to support new animal drugs intended for uncommon or undertreated diseases such as IMHA. OKAVA is one of the only companies to receive this grant for a non-oncology study in dogs.

“We are honored to be a recipient of this grant from the FDA,” said Michael Klotsman, PhD, MBA, the chief executive officer of OKAVA. “These funds will enable us to study the use of OKV-1001 in IMHA, a deadly disease with no approved therapeutic agents.”

OKAVA is collaborating with leading veterinary clinicians at Cornell University and Louisiana State University and will soon start enrolling patients for a prospective, randomized, placebo-controlled, double-masked, multi-site field safety and effectiveness study of OKV-1001 in dogs with IMHA. The study will include up to 60 dogs.

About Canine Immune-Mediated Hemolytic Anemia (IMHA)

Immune-Mediated Hemolytic Anemia (IMHA) is an autoimmune disease in dogs in which the body attacks its own red blood cells. IMHA is one of the more commonly encountered causes of anemia in dogs. Anemia is a medical term referring to a reduced number of circulating red blood cells (RBCs), hemoglobin (Hb), or both. Dogs with anemia will be listless and will tire more easily; these symptoms occur because there are not enough red blood cells to carry oxygen to the tissues. The dog may faint or appear disoriented due to low oxygen levels in the brain. To compensate for the lack of oxygen to the tissues, heart rate and respiration (breathing) rate will increase. Up to 50% of dogs diagnosed with IMHA succumb to the disease.

About OKV-1001

OKV-1001, a patented modified-release mycophenolate formulation, is the first-ever product candidate to leverage advanced drug delivery technologies to meet the unique needs of dogs. OKV-1001 is a MUMS-designated product that is under development for immune-mediated inflammatory conditions. In people, mycophenolate is an FDA-approved medicine used across a host of immune-mediated inflammatory diseases including atopic dermatitis, immune-mediated hemolytic anemia, and lupus.

OKAVA’s proprietary OKV-1001 formulation is a once-daily oral product designed to unlock the therapeutic potential of mycophenolate by improving the ease-of-use, safety, and efficacy of this drug.

About OKAVA Pharmaceuticals, Inc.

OKAVA is a clinical-stage research and development company that develops new treatment options for dogs and cats suffering from chronic diseases of aging. OKAVA is building a portfolio of products to transform and humanize standards of care in veterinary medicine. By harnessing human technologies for the treatment of common diseases in household pets, the company has the potential of increasing the lifespans of dogs and cats by an average of 1 to 3 years. OKAVA is a private company headquartered in San Francisco, California. For more information, see OKAVApharma.com.

For More Information:
Michael Klotsman, PhD, MBA Chief Executive Officer at OKAVA
Phone: 415.818.1808