DRDO’s Covid drug gets DGCI nod
An oral drug developed by the Defence Research and Development Organisation (DRDO) has been approved by the Drugs Controller General of India (DCGI) for emergency use as an adjunct therapy in moderate to severe Covid-19 patients, the defence ministry said on Saturday.
Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence, it was stated.
The drug was developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of the DRDO, in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad, based on a chemical chain known as 2-deoxy-D-glucose (2-DG).
According to the DRDO, higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid patients. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country, the DRDO stated. It comes in powder form in a sachet, and is taken orally by dissolving it in water. It accumulates in the virusinfected cells and prevents virus growth by stopping viral synthesis and energy production.
In April 2020, during the first wave of the pandemic, INMAS scientists conducted laboratory experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad. They found that this molecule works effectively against SARSCoV-2, which causes Covid-19, and inhibits viral growth.
Based on these results, DCGI Central Drugs Standard Control Organization (CDSCO) permitted PhaseII clinical trial of 2-DG in Covid-19 patients in May 2020.
DRDO along with its industry partner DRL 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, and showed significant improvement in their recovery. Phase IIa was conducted in six 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 normalisation of specific vital signs parameters when compared to SOC. Based on successful results, DCGI further permitted the Phase-III clinical trials in November 2020. This was conducted on 220 patients from December 2020 to March 2021 on a large number of patients at 27 Covid hospitals in Delhi, UP, West Bengal, Gujrat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu.
The detailed data of Phase-III clinical trial was presented to DCGI. It was found that a significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42 per cent vs 31 per cent) by Day-3.