Ahmedabad-based Zydus Cadila has become one of the first in the world to develop a new chemical entity (NCE) drug candidate to control COVID-19.
Zydus today said it has filed an Investigational New Drug (IND) application for 'ZYIL1', an oral drug candidate, that has found to be effective in pre-clinic studies to control inflammation in COVID-19 related diseases. The IND application filed with the Drug Controller General of India (DCGI) is to request permission for further studies with three phases of human clinical trials. Zydus has secured patents for the innovation in multiple countries.
ZYIL1 is a novel oral small molecule having 'NLRP3 inhibitor' properties. SARS-CoV-2 has been reported to activate the innate immune signalling sensor 'NLRP3 inflammasome', which causes 'Cytokine Storm', a condition in which the immune system attacks its own cells in COVID-19 patients and causing Acute Respiratory Distress Syndrome (ARDS) complications like organ failures, and death in severe cases.
Pharmaceutical scientists are trying ways to find a solution to tame the NLRP3 inflammasome, the root cause of severity and death among COVID-19 patients. So far, repurposed inflammatory drugs like Remdesivir, Favipiravir, Hydroxycholoroquine and Dexamethasone are being used to treat Covid-19 cases.
ZYIL1 has demonstrated promising efficacy in a number of validated pre-clinical models of Inflammatory Bowel Disease (IBD), Multiple Sclerosis (MS), Sepsis and acute lung injury models of Acute Respiratory Distress Syndrome (ARDS). The studies have demonstrated that ZYIL1 can selectively suppress inflammation caused by the NLRP3 inflammasome, said Zydus.
"We are at the forefront of targeting the innate immune system through novel NLRP3 inflammasome inhibitors candidates with deep understanding of the inflammasome biology. We are committed to developing these pioneering novel treatments to the clinic for the patients in need," said Pankaj R. Patel, Chairman, Cadila Healthcare.
Zydus is also developing two vaccines for COVID-19 and one of that, a DNA plasmid vaccine candidate, is undergoing Phase II trials and will soon move to Phase III final trials in India. The second vaccine is now in pre-clinical studies in Italy. Zydus is also one the largest manufacturers of Hydroxychloroquine and Dexamethasone in the world. It is also developing a biologic, interferon alfa treatment for COVID-19, which is currently undergoing trials in Mexico. Zydus also made India's first indigenously developed antigen test for COVID-19, 'Covid Kavach Elisa,' developed by ICMR-NIV, Pune.