Zydus applies for DCGI approval to undertake clinical trials for its monoclonal antibodies cocktail ‘ZRC-3308’
Biznextindia : Indian pharmaceutical major Zydus Cadila has applied for Drug Controller General of India (DCGI) approval to undertake phase 1-3 clinical trials for its monoclonal antibodies cocktail ZRC-3308. The company has claimed that the cocktail can neutralize COVID infection.
ZRC-3308 is a cocktail of two monoclonal antibodies targeting two unique epitopes on the spike protein of SARSCoV-2. The monoclonal antibodies of ZRC-3308 have been specifically designed to provide protection for a much longer period of time than the currently approved products. The enhanced design would also help in preventing any further tissue damage and thereby reducing the risk of severe disease. ZRC-3308 has demonstrated the ability to neutralize SARS-CoV-2 both in vitro and in animal studies. In animal studies ZRC-3308 reduced damage to the lungs in bothprophylactic and therapeutic settings. ZRC-3308 has been found to be safe and well tolerated inanimal toxicology studies.
“At this juncture, there is a critical need to explore safer and more efficacious treatments to combat COVID. It is important to look at different stages of the disease progression and look at options that can reduce patient’s suffering and discomfort. We believe that ZRC-3308 has the potential to address these concerns and provide a safe treatment” Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said.