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Modified-Release for Canine Immuno-Inflammatory Diseases
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.
Immediate-release profile limits utility in dogs: Mechanistically, MMF unquestionably offers clinical benefit. However, the immediate-release PK profile limits its clinical utility. With its narrow therapeutic index, dogs administered MMF are typically either underdosed (i.e., lack of efficacy) or overdosed (i.e., G.I. side-effects).
Improve the
gastrointestinal (GI)
tolerability
Enhanced efficacy
signal
Convenient 1x daily
dosing
Meaningfully better
than human
originator
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.
Immediate-release profile limits utility in dogs Mechanistically, MMF unquestionably offers clinical benefit. However, the immediate-release PK profile limits its clinical utility. With its narrow therapeutic index, dogs administered MMF are typically either underdosed (i.e., lack of efficacy) or overdosed (i.e., G.I. side-effects).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.
The itchy-scratchy dog (or atopic dermatitis) is the number one reason for veterinary visits. There are a variety of underlying causes to allergic itch. Food allergy, exposure to allergens such as dust mites, pollen, household cleaners, shampoos, or plants are all common causes of AD.
Common signs of AD include frequent scratching, licking, biting, or chewing. Treatment to alleviate your dog’s symptoms are often needed to restore your dog’s comfort and happiness.
For decades, mycophenolate mofetil (MMF) has been used to treat human atopic dermatitis patients. This medicine has been particularly useful in human patients who experienced poor itch control while receiving conventional treatment with systemic glucocorticoids or cyclosporine.
Based on our proprietary market research and understanding of the existing clinical needs, there remains a market need for agents with “broad inflammation‐targeting ability”. In particular, alternative treatment options are needed to help manage dogs with chronic, moderate-to-severe AD. No different than MMF’s use in human AD, OKV-1001 will be uniquely positioned to meet the needs of moderate-to-severe patients.
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 off 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.
OKV-1001: Targeting a broad commercial landscape
In human medicine, immunomodulators represent one of the most important (and lucrative) therapeutic categories. To this day, this cornerstone therapeutic arena ($100B+ in sales fo people) remains vastly underdeveloped. We continue to pump our dogs and cats full of steroids, which come with a host of side effects.
“Steroid-sparing” treatment options for dogs with immune-mediated diseases are desperately needed. OKV-1001 is being developed to meet this market need. OKV-1001 is on an accelerated approval pathway and OKAVA has received FDA grant funding to support development of this product.
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