Shanghai, October 27, 2023 – Coval Biopharma announced today that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application for CA7026, a novel topical ointment for the treatment of mild to moderate psoriasis. This achievement follows the approval of Coval's osteoarthritis (OA) program in April 2023 and its successful clinical launch in the United States, marking another key milestone for the company. With two lead programs independently developed using its Molecular Assembling Technology (MolecularX™) platform, Coval continues to earn recognition from international regulatory authorities.
About CA7026
CA7026 is an innovative topical ointment designed to treat mild to moderate psoriasis. Developed using Coval's proprietary MolecularX™ platform, the treatment combines two active small molecules chemically bonded to form a new chemical entity. The unique physicochemical properties of CA7026 allow the drug to diffuse into the stratum corneum (SC) and release active molecules directly into the epidermis and dermis, ensuring targeted and effective delivery.
About Psoriasis
Psoriasis is a chronic autoimmune disease characterized by systemic inflammation and abnormal skin cell production. It arises from an overactive immune response, causing skin cells to multiply rapidly and accumulate on the surface, resulting in red, pink, or purple scaly patches that are dry, itchy, and often painful. These patches commonly appear on the scalp, elbows, and knees but can affect other areas as well. Psoriasis affects millions worldwide, significantly impacting patients' quality of life and necessitating new therapeutic options.
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.