Shanghai, April 21, 2023 – Coval Biopharma announced today that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application for CA0678, a novel long-acting local treatment for osteoarthritis. This milestone officially transitions Coval into a clinical-stage company, marking a significant step in its mission to address the unmet medical needs of osteoarthritis patients.
About CA0678
CA0678 is an innovative treatment for osteoarthritis, developed using Coval's proprietary Molecular Assembling Technology platform (MolecularX™). This platform chemically bonds active small molecules with endogenous macromolecules to create a novel chemical entity. Delivered via intra-articular injection, CA0678 enables the controlled release of active molecules under physiological conditions, providing ultra-long-acting inflammation inhibition and pain relief. Additionally, the drug enhances patients' quality of life by leveraging the physiological benefits of endogenous macromolecules.
About Osteoarthritis
Osteoarthritis (OA) is a degenerative joint disease characterized by cartilage deterioration, subchondral bone changes, synovial inflammation, and muscle atrophy, leading to joint pain and reduced mobility. Primarily affecting the middle-aged and elderly, OA is highly prevalent:
>Over 50% of individuals aged 65+ with knee pain suffer from OA, increasing to 80% among those aged 75+.
>In China, symptomatic knee OA affects 8.1% of adults aged 45+ according to the China Health and Aging Tracking Study.
>In the U.S., an estimated 32.5 million adults (14% of the population) experienced symptomatic knee OA between 2008 and 2014.
>Globally, radiologically confirmed symptomatic knee OA affects approximately 3.8% of the population, rising to over 10% in individuals aged 60+.
Coval's CA0678 offers the potential to transform the treatment landscape for osteoarthritis, addressing both the symptoms and underlying inflammation with a long-acting and localized approach.
About Coval Biopharma
Coval Biopharma was co-founded by a team of seasoned global pharmaceutical executives and focuses on the discovery and development of novel chemical entities to address chronic inflammatory diseases. Leveraging its proprietary MolecularX™ platform, the company has built a promising pipeline of locally delivered immune modulators aimed at suppressing inflammation in targeted tissues while minimizing systemic side effects. Coval's lead programs include JAK inhibitor conjugates for osteoarthritis, psoriasis, and hand arthritis, with several currently in Phase I/II clinical trials in the U.S. and Australia.