Zydus Cadila gets DCGI nod for Phase I trial of new drug aimed to treat rheumatoid arthritis

Pharmaceutical major Zydus Cadila on Tuesday said it has received approval from the Drug Controller General of India (DCGI) to initiate Phase I clinical trials for a new drug entity intended to treat Rheumatoid Arthritis.

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."