Cadila Healthcare Receives DCGI Nod For Clinical Trials

Cadila Healthcare on Tuesday said it received permission from the Drug Controller General of India (DCGI) to initiate Phase I clinical trials for a new chemical entity.

The company has received an approval from DCGI to initiate Phase I clinical trials for its Investigational New Drug (IND) ZYBK2, a New Chemical Entity (NCE) intended to treat Rheumatoid Arthritis (RA).

RA 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. While its most visible hallmarks are pain, stiffness, inflammation and eventual deterioration of joints, patients also are at heightened risk for cardiovascular disease and other inflammatory complications. Nearly 13 million are estimated to stiffer from the disease in India.

Speaking on the development, Pankaj Patel, chairman, Zydus Group said, “There is significant unmet medical needs among patients with Rheumatoid Arthritis (RA). Unlike other therapeutic strategies for managing RA, targeting upstream molecular interactions with ZYBK2 is less likely to cause adverse events. This clinical trial will seek to find answers if inhibiting HLA-DRB 1-mediated effects could provide a safe remedy for treating this debilitating disease.”

Shares of Cadila Healthcare were down 0.28% at Rs 249. Meanwhile, the S&P BSE Sensex was up 195.01 points or 0.51% at 38,339.03.

On a consolidated basis, the drug maker’s net profit fell 26.5% to Rs 375.18 crore on a 0.5% increase in net sales to Rs 3,534.50 crore in Q3 December 2019 Q3 December 2018.

Cadila Healthcare is an pharmaceutical company based in India.-Business Standard