Osteoarthritis (OA) is a world health epidemic with 80% of adults over the age of 60 exhibiting some clinical sign of the disease. There are no therapeutics that cure the disease so that pain and symptom management are the only current treatment options. Excessive cartilage matrix degradation with subsequent osteophyte formation is the major pathological event in OA. Our product is a small peptide that inhibits osteophyte formation and prevents matrix degradation, two main cellular disorders in OA.
Our molecule represents a novel, safe, effective and economical approach to management and reversal of the pathology associated with OA. Our company's strategy for developing this OA treatment is to target the veterinary market first for an early exit that will provide supporting clinical data for the human drug FDA application and financial support for the longer commercialization path necessitated by developing a human therapeutic.
Our current, primary objective is to demonstrate the safety and efficacy of a proprietary new treatment for osteoarthritis in dogs. We are expecting efficacy and safety to be similar to what we observed in the rat model of OA. This study will provide necessary safety and efficacy data for translation into an Investigational New Animal Drug (INAD) application. In addition, the data generated in this project can be used to support the subsequent initiation of clinical studies in humans, designed to show efficacy in this important patient population.
ProteaPex Therapeutics, LLC holds a broad-based patent application detailing a disruptive technology that can accommodate a platform of products to address many diseases.