Seeks DCGI nod for Phase 1 of 3-phase clinical trials of two SARS-CoV-2-neutralising monoclonal antibodies
Days after Roche India announced the launch of its Rs 59,750 per dose Antibody Cocktail for the treatment of mild to moderate Covid-19 in high risk patients, Zydus Cadila on Thursday said it is seeking permission from Drugs Controller General of India (DCGI) to initiate human clinical trials for its own monoclonal antibodies cocktail to treat Covid-19.
“Zydus is currently seeking permission to initiate Phase 1 of a three-phase human clinical trial from DCGI... ZRC-3308, a cocktail of two SARS-CoV-2-neutralising monoclonal antibodies (mAbs) can emerge as one of the main treatments for mild Covid,” Cadila Healthcare said in a regulatory filing.
Cadila Healthcare is the listed entity of the group.
ZRC-3308 has been found to be safe and well tolerated in animal toxicology studies.
Zydus said it is the only Indian company to have developed a neutralising monoclonal antibody-based cocktail for the treatment of Covid-19.
Dr Sharvil Patel, managing director, Cadila Healthcare Limited, said, “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 at options that can reduce patient’s suffering and discomfort.
“We believe ZRC-3308 has the potential to address these concerns and provide a safe treatment.”