Monday, June 21, 2021

DGCI gives emergency approval of DRDO-developed anti-Covid drug

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The drug has been developed by Institute of Nuclear Medicine and Allied Sciences, a lab of DRDO, in collaboration with Dr Reddy’s Laboratories, Hyderabad. Clinical trial results have shown that this molecule helps in faster recovery of hospitalized patients and reduces supplemental oxygen dependence.

An anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of DRDO, in collaboration with Dr Reddy’s Laboratories, Hyderabad. Clinical trial results have shown that this molecule helps in faster recovery of hospitalized patients and reduces supplemental oxygen dependence. Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients. The drug will be of immense benefit to the people suffering from COVID in the ongoing pandemic.

Pursuing the Hon’ble Prime Minister’s call for preparedness against the pandemic, DRDO took the initiative of developing anti-COVID therapeutic application of 2-DG. In April 2020, during the first wave of pandemic INMAS-DRDO scientists conducted laboratory experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth. Based on these results, Drugs Controller General of India’s (DCGI) Central Drugs Standard Control Organization (CDSCO) permitted Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020.

DRDO along with its industry partner Dr Reddy’s Laboratories (DRL, Hyderabad) started the clinical trials to test the safety and efficacy of the drug in COVID-19 patients. In Phase-II trials (including dose ranging) conducted during May to October 2020, the drug was found to be safe in COVID-19 patients, and showed significant improvement in their recovery. Phase IIa was conducted in 6 hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients. In efficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints. A significantly favourable trend (2.5 days difference) was seen in terms of the median time to achieving normalization of specific vital signs parameters when compared to SOC.

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