COVID-19: Zydus Cadila seeks DCGI approval for clinical trials for monoclonal antibody therapy
Zydus Cadila is the only Indian company that has been able to develop a neutralizing monoclonal antibody-based cocktail to neutralize COVID-19. Read what is monoclonal antibody therapy?
Zydus Cadila announced on May 26, 2021, that the company is seeking approval from the Drugs Controller General of India (DCGI) to conduct clinical trials of its monoclonal antibody therapy ZRC-3308 (COVIMAB) that can neutralize COVID-19.
Dr Sharvil Patel, Managing Director, Cadila Healthcare in a statement informed that the biological therapy ZRC-3308, a cocktail of two anti-SARS-CoV-2-neutralizing monoclonal antibodies (mAbs) has the potential to address concerns about the progression of the COVID-19 infection.
The company stated in a tweet further said that at this point, we should be exploring more safer and efficacious treatments to fight COVID-19 to reduce patients' discomfort and suffering.
Zydus seeks DCGI approval to undertake clinical trials for monoclonal antibodies cocktail that can neutralise COVID infection. #biologicaltherapy #IndiaFightsCorona #innovation #innovateindia #zydus #Zyduscadila #cadila #makeinindia #covid19 #corona #Atmanirbharbharat pic.twitter.com/fmvLLNjNrR— Zydus Cadila (@ZydusUniverse) May 27, 2021
What is COVIMAB?
•COVIMAB, a cocktail of two anti-SARS-CoV-2-neutralizing monoclonal antibodies (mAbs) therapy ZRC-3308 has been designed by Zydus Cadila, an Ahmedabad-based pharmaceutical company in India.
•Zydus Cadila is the only Indian company that has been able to develop a neutralizing monoclonal antibody-based cocktail to neutralize COVID-19.
•The biological therapy ZRC-3308, a cocktail of two SARS-CoV-2-neutralizing monoclonal antibodies (mAbs) that has the potential to neutralize COVID-19 infection.
What is monoclonal antibody (mAb) therapy?
•SARS-CoV-2’s spike protein facilitates the virus in entering into the body’s cells. Monoclonal antibodies (mAbs) target epitopes of SARS-CoV-2’s spike protein.
•Single Monoclonal antibody (mAb) therapy targeting SARS-CoV-2’s spike protein has been approved for emergency use in Europe, India, and the US. However, the US FDA had recently withdrawn the authorization when the single mAb-based therapy was found ineffective on the variants.
•In the case of COVIMAB, a cocktail of two monoclonal antibodies (mAbs), the antibodies will target two unique epitopes of SARS-CoV-2’s spike protein. Two mAbs based products have better efficacy at fighting variants compared to single mAb-based products.
•A press release by Zydus Cadila stated that the biological therapy ZRC-3308 has been specifically devised in a way that provides protection for a long time than the currently approved treatments for COVID-19.
Zydus Cadila: COVID-19 Vaccine
•Ahmedabad-based pharmaceutical company Zydus Cadila is also seeking approval for its COVID-19 vaccine ZyCoV-D from the central government. It is expecting to get the authorization by June 2021.