OKAVA Pharmaceuticals Announces First Cat Dosed in MEOW-1 Study of OKV-119, the World's First Clinical-Stage GLP-1 Weight-Loss Therapy for Pets

SAN FRANCISCO - Amzeal -- OKAVA Pharmaceuticals is a clinical-stage company developing medicines to enable dogs and cats to live longer, healthier lives. Today, the company announced that the first cat has been successfully dosed in MEOW-1 (ManagEment of OverWeight cats with OKV-119), a landmark clinical study evaluating OKV-119, an investigational, first-in-class, ultra-long-acting GLP-1 implant being developed specifically for weight management in cats. Beyond weight loss, the implications of this pet-tailored GLP-1 solution for diabetes, kidney disease, and healthy aging and longevity may be profound.

By improving cardiometabolic health through continuous delivery of a GLP-1 receptor agonist, OKV-119 has the potential to enhance quality of life, promote healthy aging, and become the most impactful life-extending therapy available for cats.

OKV-119 leverages the NanoPortal™ technology platform developed by Vivani Medical. The novel drug-delivery system is designed to provide smooth and steady delivery of therapeutic molecules, including GLP-1 receptor agonists, over extended periods from a single implant. This "One-and-Done" hassle-free solution is designed to guarantee that cats remain adherent for up to six months with a single implant administered during a routine office visit.

MEOW-1 marks the first-ever GLP-1 weight-loss clinical trial in cats or dogs, a landmark moment for veterinary medicine. In human medicine, GLP-1 receptor agonists have revolutionized the management of obesity, diabetes, and cardiometabolic health, becoming one of the most important therapeutic breakthroughs of the 21st century. OKAVA is now working to bring this same transformational class of medicines to dogs and cats, with an ultra-long-acting solution specifically engineered for safe and effective use in companion animals.

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"Caloric restriction, or fasting, is one of the most well-established interventions for extending lifespan and improving metabolic health in cats," said Michael Klotsman, PhD, MBA, CEO of OKAVA. "But it's also one of the hardest to maintain. OKV-119 is designed to mimic many of the physiological effects of fasting — improved insulin sensitivity, reduced fat mass, and more efficient energy metabolism — without requiring significant changes in feeding routines or disrupting the human–animal bond that often centers around food."

The MEOW-1 study is being conducted under an FDA-CVM Investigational New Animal Drug (INAD) application and will evaluate the safety, tolerability, and weight-loss efficacy of OKV-119 in overweight or obese client-owned cats. Results from the study will inform future clinical development and regulatory filings and are expected to guide the initiation of similar studies in dogs. As part of its commitment to responsible, transparent clinical research, OKAVA has listed the MEOW-1 study in the American Veterinary Medical Association (AVMA) Clinical Trials Registry.

About OKV-119

OKV-119 is a miniature, subdermal exenatide implant designed to address the growing prevalence of obesity, diabetes and kidney disease in cats. The product utilizes Vivani Medical's NanoPortal™ technology platform. The implant can be inserted under the skin during a routine veterinary visit and is designed to deliver a steady dose of medication for up to six months.

OKV-119 is being developed by OKAVA in partnership with Vivani Medical under an exclusive veterinary licensing and collaboration agreement.

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About OKAVA Pharmaceuticals
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 breakthrough human technologies for the treatment of common diseases in household pets, the company has the potential to increase 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 OKAVA.com.

About Vivani Medical

Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence and improving patient tolerance to their medication. Vivani is developing a portfolio of GLP-1 based implants for metabolic diseases including obesity and type 2 diabetes. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. For more information, see www.vivani.com.

For inquiries, contact:

Michael Klotsman
info@okava.com
415.818.1808