Zydus seeks DCGI approval for clinical trial of monoclonal antibodies cocktail

by IANS |

New Delhi, May 27 (IANS) Zydus Cadila on Thursday announced that its biological therapy ZRC-3308, a cocktail of two SARS-CoV-2-neutralizing monoclonal antibodies (mAbs) can emerge as one of the main treatments for mild COVID-19.

SARS-CoV-2 spike protein targeted, neutralizing monoclonal antibody based treatments have received emergency use authorization in mild COVID cases in the US, Europe and in India because they significantly reduced viral load in mild patients and their rate of hospitalization.

Two of these products are cocktail based products comprising of two mAbs binding to two different epitopes on the spike protein of SARS-CoV-2 virus. Cocktail of 2 mAbs based products are better equipped to deal with variants than single mAb based products which have a tendency of losing their efficacy with rapidly generating variants.

Zydus is the only Indian company to have developed a neutralizing monoclonal antibody based cocktail for the treatment of COVID-19.

Sharvil Patel, Managing Director, Cadila Healthcare Ltd, 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 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."

Recently, the US FDA withdrew the emergency use authorization of a mAb product after new variants emerged in the country that were not being neutralized by the product. 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 both prophylactic and therapeutic settings. ZRC-3308 has been found to be safe and well tolerated in animal toxicology studies. Zydus is currently seeking permission to initiate phase 1/3 human clinical trials from the DCGI.

Latest News
SIT officers acting like agents of Siddaramaiah & Shivakumar, says Kumaraswamy Tue, May 07, 2024, 04:08 PM
Lalu Prasad bats for Muslim reservation, Samrat Choudhary hits back Tue, May 07, 2024, 03:49 PM
Chikkodi leads as polling picks up pace in Karnataka's 14 LS seats Tue, May 07, 2024, 03:32 PM
Excise policy case: Delhi court extends CM Kejriwal's judicial custody till May 20 Tue, May 07, 2024, 03:30 PM
Truecaller's net sales up 8 pc in India with over 234 million daily active users Tue, May 07, 2024, 03:28 PM
AWS to invest additional $9 bn in Singapore to grow its cloud infrastructure Tue, May 07, 2024, 03:13 PM
Sex videos: Court adjourns bail plea of JD(S) MLA Revanna in victim abduction case Tue, May 07, 2024, 03:04 PM
Ending Pakistan's long wait, Saudi Crown Prince could visit Islamabad next week Tue, May 07, 2024, 03:01 PM
Israeli army takes control of Rafah crossing in Gaza Tue, May 07, 2024, 02:55 PM
Rafah crossing from Egyptian side closed indefinitely for aid, individual passage: Source Tue, May 07, 2024, 02:34 PM
IDF takes control of Rafah border crossing in Gaza Tue, May 07, 2024, 02:33 PM
J&K Police attaches properties of 7 Pak-based militant handlers in Baramulla Tue, May 07, 2024, 02:22 PM
Constituency Watch: Amid Maratha quota stir, election in Beed is more about caste politics than national issues Tue, May 07, 2024, 02:13 PM
Your one vote will make India third largest economy, says PM Modi in Madhya Pradesh Tue, May 07, 2024, 01:54 PM
Ex-CM Basavaraj Bommai casts vote, appeals to people to vote in record numbers Tue, May 07, 2024, 01:12 PM