Extensively studied in
human patients, we start
with well characterized FDA
approved medicines.
Published data demonstrate
that the human clinical
experience carries over to
dogs and cats.
OKAVA’s pet-specific
products are clinically and
meaningfully improved
CellCept® represents a human therapeutic success story. CellCept (or mycophenolate mofetil, MMF) possesses the unique combination of broad immunomodulating properties, coupled with a well-established safety profile. This impressive clinical profile led CellCept to become one of the first “steroid sparing” agents to reach $1B Blockbuster status. It remains one of the most commonly used therapeutic agents for treating human patients with immune-mediated inflammatory diseases.
Why hasn’t the value of MMF translated over into the veterinary setting? The key to that question, we believe, centers on its suboptimal and clinically limiting “immediate release” pharmacokinetic profile.
People and dogs share the same pathophysiologic inflammatory mechanisms underpinning atopic dermatitis and other inflammatory skin diseases. By extension, the broad immunomodulating properties of MMF have been well established in canines. Based on our experiences studying this medicine in dogs, we believe this therapeutic modality holds significant clinical value for treating dogs with a host of immune-mediated inflammatory diseases.
To unlock the therapeutic potential of the human originator product in canine patients, Okava developed a novel modified-release formulation with clinically meaningful benefits (OKV-1001).
Although the dog is often used as a preclinical species during human drug formulation development, advanced MR drug delivery technologies have not been widely adopted for orally administered companion animal products. OKV-1001 is one of the first modified release formulations ever developed for dogs.
Modified release (MR) oral dosage forms designed to improve the performance of immediate-release formulations (e.g., increase the therapeutic activity compared to the intensity of side effects, reduce the number of drug administrations required during treatment) are commonly developed for human applications. For example, an enteric coated formulation designed to improve the gastrointestinal (GI) tolerability of MPA has been developed.
Immune-mediated hemolytic anemia (IMHA), one of the most common immune-mediated diseases diagnosed in dogs, is a serious and life-threatening condition. It is estimated that up to 50% of dogs diagnosed with IMHA succumb to this disease. In dogs with IMHA, the immune system, which typically fights of invaders and infections, starts to attack its own red blood cells. This results in the red blood cells being destroyed, causing anemia, as well as system inflammation (damage) around your pet’s whole body.
To this day, generic steroid therapy is the most commonly prescribed medicine used to treat IMHA. While steroid therapy may be effective in some patients, the use of steroids are associated with serious adverse events. The lack of safe and effective “steroid sparing” agents represents an area of high unmet medical need. OKV-1001 will address this sizable market segment that is currently limited to chronic steroid use.
Okava was awarded a $500k grant from the FDA to develop OKV-1001 for IMHA. The clinical utility of OKV-1001 will also be investigated in other severe immune-mediated inflammatory diseases such as pemphigus, lupus, and myasthenia gravis.
In this review paper, the inventor of mycophenolate mofetil (MMF) describes the drug’s mechanism of action.
Immunopharmacology. 2000; 47(2-3):85-118.
With a long history in human medicine, the clinical utility of mycophenolic acid for treating inflammatory skin
disease (psoriasis) was initially published in the 1970’s.
The Journal of Investigative Dermatology. 1975; 65:537-542.
As demonstrated in this clinical study, MMF has been used to treat human patients with moderate-to-severe
atopic dermatitis that have a poor response to conventional treatment with steroids and cyclosporine.
Archives in Dermatology 2001. 137(7):870-873.
The increasing use of MMF in the treatment of patients with various autoimmune inflammatory diseases is
reviewed in this paper.
Clinical Pharmacokinetic. 2013. 52(5):303-31.
GLP-1 receptor agonists (GLP-1RAs) are now a cornerstone treatment of type 2 diabetes mellitus (DM) in human medicine, with exenatide being the first-in-class GLP-1RA to be approved. GLP-1RAs have also been shown to beneficially reduce body weight in non-diabetic obese people, without causing hypoglycemia or other serious adverse events (AEs). Weight-reducing effects are partly attributed to GLP-1 inhibitory effects on gastric emptying, postprandial glucagon release, and stimulation of hypothalamic satiety centers.
Emerging studies in cats demonstrate that GLP-1RAs generally have similar effects to those seen in human patients and might be useful as weight-loss agents and in treating feline diabetes. However, human GLP-1RAs remain out of reach for most feline patients.
The clinical use of human originator GLP-1RAs in veterinary medicine are limited by:
Our proprietary NanoPortal™ technology reimagines drug delivery. Imagine only having to give your pet medicine twice-a-year.
OKV-119, roughly the size of commonly used tracking chips, is a state-of-the art “hassle free” drug delivery system. Easily inserted during routine clinic visits, each OKV-119 implant is designed to safely delivery exenatide for a 6-month duration.
This drug delivery system is composed of biocompatible materials commonly found in FDA approved products. Tunable drug release rates are achieved without any moving parts or electronics.
The technology benefits are well suited for pet owners (and feline patients):
In this review paper, the inventor of mycophenolate mofetil (MMF) describes the drug’s mechanism of action.
Immunopharmacology. 2000; 47(2-3):85-118.
With a long history in human medicine, the clinical utility of mycophenolic acid for treating inflammatory skin disease (psoriasis) was initially published in the 1970’s.
The Journal of Investigative Dermatology. 1975; 65:537-542.
As demonstrated in this clinical study, MMF has been used to treat human patients with moderate-to-severe atopic dermatitis that have a poor response to conventional treatment with steroids and cyclosporine.
Archives in Dermatology 2001. 137(7):870-873.
The increasing use of MMF in the treatment of patients with various autoimmune inflammatory diseases is reviewed in this paper.
Clinical Pharmacokinetic. 2013. 52(5):303-31.
The OKAVA teams reviews the emerging use of MMF to treat canine patients across a host immune-mediated disease.
Journal of Veterinary Pharmacology and Therapeutics. 2019; 42(2):127-138.
MMF is commonly used to treat human lupus patients. In these two papers, the successful use of MMF to treat a dogs with lupus is presented.
Veterinary Dermatology 2019; 30(4):350-e102
Veterinary Science 2021; 8(5):72
Recent consensus guidelines from ACVIM recommend MMF as an adjunctive agent for the treatment of immune-mediated hemolytic anemia.
Journal of Veterinary Internal Medicine 2019; 33(3):1141-1172
Although highly effective in canine patients, this OKAVA publication highlights the challenges of using the immediate release [human] formulation in dogs.
Journal of Veterinary Pharmacology and Therapeutics. 2021.
The Proof-of-Concept paper for OKV-1001 demonstrates that the modified release formulation is meaningfully differentiated over the originator [human] MMF immediate release formulation.
Frontiers in Veterinary Science. 2021.
This clinical trial replicates well-established studies in people and demonstrates that OKV 1001 is safe and effective in treating household dogs with chronic itch (or atopic dermatitis) who responded poorly to conventional treatment options.
Veterinary Dermatology 2024
A detailed overview of the multifaceted nature of glucagon-like peptide-1 (GLP-1), an important incretin hormone, and its therapeutic role in various diseases is reviewed in this paper.
Molecular Metabolism. 2019; 30:72-130.
The evolution and advancements of GLP-1 receptor agonists (GLP-1RAs), viewed through the lens of randomized clinical studies, have established GLP-1RAs as a cornerstone treatment for diabetes.
Diabetes Obesity and Metabolism 2018; 20(Suppl 1):22-33
Landmark studies demonstrating that GLP-1RAs are safe and effective weight-loss agents.
Diabetes Care. 2010;33(6):1255-61
New England Journal of Medicine 2021. 384:989-1002
The clinical importance of adherence and persistence, as well as the associated challenges of achieving good compliance in real-world settings, are well documented.
Scientific Reports. 2018; 8:12190
Diabetes Care 2017; 40(11): 1469-1478
Similar to data generated in people, the beneficial mechanistic effects of GLP-1 receptor agonists (GLP-1RAs) have been established in cats.
Domestic Animal Endocrinology. 2011; 41(1):42-9
Domestic Animal Endocrinology. 2015; 51:78-85
As highlighted in this review article, GLP-1 receptor agonists (GLP-1RAs) are attractive agents for treating feline diabetes.
Journal of Feline Medicine and Surgery. 2016; 18(9):733-43.
Initial clinical trials in household cats demonstrate that GLP-1 receptor agonists (GLP-1RAs) are safe and effective treatments for diabetes.
Journal of Veterinary Internal Medicine. 2016; 30(1):92-100
Domestic Animal Endocrinology. 2018; 65:80-89
Journal of Veterinary Internal Medicine. 2020; 34(6):2287-2295
The safety, tolerability, and weight-reducing effects of OKV-119 administered to cats are demonstrated in this Proof-of-Concept study.
Frontiers in Veterinary Science. 2021
The safe and effective weight-loss properties of a single OKV-119 implant
over a 112-day study period are demonstrated in this study.
BMC Veterinary Research 2024.
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