Shanghai, January 12, 2024 – Coval Biopharma announced today that the first patient has been dosed in a Phase I clinical trial evaluating CA0678, a novel long-acting local drug for the treatment of osteoarthritis. The company secured early clinical approval from the U.S. Food and Drug Administration (FDA) in April 2023 to begin this study, which aims to assess the safety and efficacy of CA0678 in patients with mild-to-moderate osteoarthritis. Results from the trial are expected to provide a strong foundation for late-stage clinical development.
Dr. Zhang, CEO of Coval, expressed enthusiasm about the milestone: "This marks a pivotal moment for Coval as we advance our first clinical trial in the U.S. The enrollment of our first patient symbolizes the beginning of CA0678's clinical development and highlights our commitment to addressing the global burden of osteoarthritis. We aim to bring an innovative solution to patients worldwide suffering from this debilitating condition."
About Osteoarthritis
Osteoarthritis (OA) is among the most prevalent forms of arthritis, affecting approximately 302 million people globally. The disease poses a significant societal and economic burden. Existing treatments primarily focus on symptom relief and fail to halt or reverse disease progression. Challenges such as limited pain relief, short efficacy duration, adverse side effects, and poor patient compliance underscore the urgent need for a safer, more effective, and long-acting therapy.
About CA0678
CA0678 is a groundbreaking treatment for osteoarthritis developed using Coval's proprietary Molecular Assembling Technology platform (MolecularX™). This technology chemically links active small molecules with endogenous macromolecules, creating a novel chemical entity. Delivered through intra-articular injection, CA0678 gradually releases active molecules under physiological conditions, offering prolonged inflammation inhibition and pain relief. Additionally, it leverages the physiological benefits of endogenous macromolecules, aiming to enhance patients' quality of life.
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.