Category: News

Published in Frontiers in Veterinary Research, the Feasibility of Long-Term Drug Delivery of the GLP-1 Exenatide is Demonstrated in this Study Conducted in Cats

San Francisco, California – May 11, 2021 – OKAVA Pharmaceuticals, Inc., a clinical stage research and development company focused on diseases of aging in dogs and cats, today announced the publication of a proof-of-concept study in Frontiers in Veterinary Research, a leading peer-reviewed open access scientific journal. The publication demonstrates that long-term drug delivery can be achieved with the NanoPortal™ drug delivery system in cats.

“Obesity and diabetes are arguably the biggest challenges in feline medicine today,” said Michael Klotsman, PhD, MBA, the CEO of OKAVA. “Existing human therapeutics are of limited use in cats because oral dosing in cats is a major barrier to treatment. OKV-119 is a ‘one-and-done’ solution that holds the potential of revolutionizing treatments in cats and extending their lifespans.”

This study demonstrates that long-term drug delivery in cats can be achieved with a single OKV-119 implant. This study also provides evidence that OKV-119 is safe and can be conveniently inserted under the skin during routine veterinary visits.

About OKV-119

OKV-119 is a miniature, subdermal, exenatide drug implant designed to treat the growing number of clinically obese cats and feline diabetes. This device can be conveniently inserted under the skin during routine veterinary visits and is designed to provide steady doses of medication for up to six months.

OKV-119 is being developed under a partnership with Vivani Medical, Inc.

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.

About Vivani Medical, Inc.

Leveraging its proprietary NanoPortal™ platform, Vivani Medical develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve tolerance to their medication. NPM’s lead program NPM-119 is a miniaturized, 6-month GLP-1 implant under investigation for the treatment of patients with type 2 diabetes and is also under consideration for the treatment of obesity. NPM-119 is designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables. 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. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason why type 2 diabetes treatments face significant challenges in achieving positive real-world effectiveness.

For More Information:
Michael Klotsman, PhD, MBA Chief Executive Officer at OKAVA
Phone: 415.818.1808
E-mail: info@okavapharma.com

Vivani Contact:
Donald Dwyer
Chief Business Officer
info@vivani.com
(415) 506-8462

Vivani Investor Relations Contact:
Brigid A. Makes
Chief Financial Officer
investors@vivani.com
(415) 506-8462

Published in Frontiers in Veterinary Research, This Proof-of-Concept Study Demonstrates the Clinical Advantages of OKV-1001 Over Immediate-Release CellCept®

San Francisco, California – January 28, 2021 – OKAVA Pharmaceuticals, Inc., a clinical stage research and development company focused on diseases of aging in dogs and cats, today announced the publication of a proof-of-concept study in Frontiers in Veterinary Research, a leading peer-reviewed open access scientific journal. The publication details the clinical benefits of using advanced modified release drug delivery technology in dogs.

“OKAVA is the first company to utilize advanced drug delivery technologies for use in companion animals. This study demonstrates that meaningful clinical benefits of drug delivery, which have been available for decades in people, can also be applied to dogs,” said Michael Klotsman, PhD, MBA, the CEO of OKAVA. “It is our belief that by leveraging drug delivery technologies, we can unlock the clinical potential of existing human therapeutics to advance the well-being of pets.”

The laboratory-based study, performed in healthy Beagles, benchmarked the performance of OKV-1001 against immediate release (IR) CellCept®. Compared to CellCept®, approved for use in people by the FDA, the data generated shows that once-daily administration of OKV-1001 is more efficacious and better tolerated by dogs.

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.

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

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

MUMS Designation Places OKV-1001 on an Accelerated Conditional Approval Pathway and Demonstrates That the FDA Considers OKV-1001 To Be an Innovative Product That Addresses High Unmet Medical Need

San Francisco, California – November 8, 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 was granted a Minor Use/Minor Species (MUMS) Drug Designation for OKV-1001 by the FDA. OKV-1001 is a modified release mycophenolate that is being developed for immune-mediated hemolytic anemia in dogs.

The Center for Veterinary Medicine (CVM), a division of U.S. Food and Drug Administration, Minor Use/Minor Species (MUMS) program was developed to support new animal drugs intended for uncommon or undertreated diseases such as IMHA.

“IMHA is a debilitating disease with no approved treatment options,” said Michael Klotsman, PhD, MBA, the chief executive officer of OKAVA. “IMHA has been ignored by far too long by the established animal health companies. Given the success of treating human IMHA patients with mycophenolate, we believe OKV-1001 has the potential to tackle this disease in dogs.”

The MUMS Drug Designation is modeled on the “Orphan Drug Act” for humans. It grants OKAVA seven years of exclusive market rights, which means that OKAVA will face no competition during that time period. The designation also makes OKV-1001 eligible for conditional approval. Accelerated conditional approval, once received, will allow OKAVA to market the drug and will then have up to five years to submit additional data for full approval.

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 (MR) mycophenolate formulation, is the first-ever product candidate to leverage advanced MR 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

Collaboration Leverages NanoPortal™, A Best-in-Class Drug-Device Technology Developed by Nano Precision Medical, For Use in Feline Obesity and Diabetes

San Francisco, California. – October 19, 2019 – OKAVA Pharmaceuticals, Inc., a clinical stage research and development company focused on diseases of aging in dogs and cats, announced today entering into a strategic partnership with Nano Prescison Medical, Inc. (NPM). This collaboration if focused on the development of miniaturized, long-term biopharmaceutical implants for feline obesity and diabetes with the goal of guaranteeing adherence, and potentially to improve tolerance to this medication. The proprietary, novel drug-device combination product (OKV-119) utilizes industry-leading drug delivery technology, NanoPortal™, to develop months long drug release of the GLP-1 exenatide for veterinary use.

“An alarming percentage of pet owners are unable to medicate their dogs and cats because of the challenges associated with drug administration. By leveraging NPM’s NanoPortal technology, we can overcome the challenges of medication non-adherence,” said Michael Klotsman, PhD, chief executive of OKAVA. “By adopting state-of-the-art human technologies, our goal is to bring next generation veterinary therapeutics, with superior product profiles at affordable prices, to the market in order to address unmet medical needs of household pets.”

About OKV-119

OKV-119 is a miniature, subdermal, exenatide drug implant designed to treat the growing number of clinically obese cats and feline diabetes. This device can be conveniently inserted under the skin during routine veterinary visits and is designed to provide steady doses of medication for up to six months.

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.

About NanoPrecision Medical, Inc.

Leveraging its proprietary NanoPortal™ platform, NanoPrecision Medical develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve tolerance to their medication. NPM’s lead program NPM-119 is a miniaturized, 6-month GLP-1 implant under investigation for the treatment of patients with type 2 diabetes and is also under consideration for the treatment of obesity. NPM-119 is designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables. 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. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason why type 2 diabetes treatments face significant challenges in achieving positive real-world effectiveness.

For More Information:
Michael Klotsman, PhD, MBA Chief Executive Officer at OKAVA
Phone: 415.818.1808
E-mail: info@okavapharma.com

NPM Contact:
Donald Dwyer
Chief Business Officer
info@vivani.com
(415) 506-8462

NPM Investor Relations Contact:
Brigid A. Makes
Chief Financial Officer
investors@vivani.com
(415) 506-8462

A Clear Path to Regulatory Approval Has Been Established For the Use Of OKV- 1001 in IMHA

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.

About immune-mediated hemolytic anemia (IMHA) in dogs

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.

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
E-mail: info@okavapharma.com