The DCGI has approved conducting test on a limited number of patients for investigational new drug ZYBK2, which is a new chemical entity (NCE), the company said in a regulatory filing.
ZYBK2 has been specifically designed to inhibit a particular genetic sequence -- HLA-DRBI shared epitope (SE) -- that determines susceptibility of a person to develop Rheumatoid Arthritis (RA). The vast majority of RA patients carry this genetic sequence, it added.
The molecule addresses high unmet medical need and has a large market potential for treatment of the disease.
Commenting on the development, Zydus Group Chairman Pankaj Patel said, "There is significant unmet medical needs among patients with Rheumatoid Arthritis. Unlike other therapeutic strategies for managing RA, targeting upstream molecular interactions with ZYBK2 is less likely to cause adverse events."
He further said: "This clinical trial will seek to find answers if inhibiting HLA-DRBl-mediated effects could provide a safe remedy for treating this debilitating disease."
The company said nearly 13 million people are estimated to suffer from RA, which is a progressive, systemic autoimmune disease that affects at least 1 in every 100 people worldwide.
Autoimmune diseases cause the body's immune system to mistakenly attack one's own healthy normal tissues. In case of RA, the body's own immune system attacks the lining of joints and can affect other body organs as well, it added. RKL SHWSHW