Zydus Cadila shines post approval for clinical trial

Zydus Cadila announced that it has received an approval from Drug Controller General of India (DCGI) in order to initiate Phase 1 clinical trials for its Investigational New Drug (IND) ZYBK2.

Investigational New Drug (IND) ZYBK2 which is a New Chemical Entity (NCE) is intended to treat Rheumatoid Arthritis (RA). RA is considered as a progressive, systemic autoimmune disease that causes the body’s immune system to mistakenly attack the person’s own healthy normal tissues.

ZYBK2 is designed to inhibit HLA-DRBI Shared Epitope (SE) which determines susceptibility of a person to develop rheumatoid arthritis. The vast majority of RA patients carry this genetic sequence. ZYBK2 inhibits this SE and calreticulin interaction.

Thus, the molecule addresses high unmet medical need and has a large market potential for treatment of RA. Pankaj Patel, Chairman of Zydus Group commented that the clinical trial will seek to find answers if inhibiting HLA—DRBl-mediated effects could provide a safe remedy for treating this debilitating disease. Zydus has acquired the rights for this molecule and has conducted all the development work including IND enabling non-clinical studies at Zydus Research Centre, the R&D hub of Zydus Group.

Reacting to the news, on Tuesday, the stock of Cadila Healthcare closed at Rs 260.50, up by 4.33 per cent or Rs 10.80 per share. The 52-week high is Rs 352.30 and 52-week low is Rs 206.45 on BSE.