Zydus seeks DCGI’s approval

Zydus seeks DCGI’s approval for COVID-19 biological therapy

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Zydus seeks DCGI’s approval for conducting clinical trials of its COVID-19 biological therapy :

Zydus Cadila has recently sought the DCGI’s[1] approval for conducting clinical trials of its new COVID-19 treatment. This is a monoclonal antibody (mAb) based cocktail that can neutralize COVID-19 infection. 1

The pharma firm stated that the antibodies are made by cloning unique white blood cells. This biological therapy, called ZRC-3308, is specially developed by Zydus using two SARS-CoV-2[2] neutralizing monoclonal antibodies. It is expected to be mainly used for treating mild COVID-19.

EUA[3] is often granted in the US, Europe, and India for treatments that target the SARS-CoV-2 spike protein or are based on neutralizing mAbs. This is attributed to the fact that such treatments reduce the viral load and decrease the risk of hospitalization.

Variant strains can be better handled using cocktails of two mAbs rather than a single-mAb based product. This is because the latter tends to lose its efficacy when exposed to rapidly generating variants.

Zydus seeks DCGI’s approval.

The company’s Managing Director revealed that ZRC-3308 is a safe treatment option. He firmly believes that this combination would reduce the patient’s suffering and discomfort.

ZRC – 3308 targets two unique epitopes on the spike protein of the SARS-CoV-2. The mAbs of this therapy are designed to provide much longer protection than the currently approved products. The company also stated that this design reduces the risk of severe disease by preventing the progression of tissue damage.

In 2020, Biocon’s mAb Itolizumab was granted “restricted emergency use” by DCGI to treat COVID – 19. This antibody was originally used to cure psoriasis. The USFDA[4], too, granted the EUA to Eli Lilly’s bamlanivimab (LY – CoV555) to treat mild to moderate COVID – 19 patients. It was also permitted for use in some pediatric patients. This authorization was revoked later on as it was ineffective against the variants of the virus.

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