The Drugs Controller General of India (DCGI) has approved the emergency use of drug 2-deoxy-D-glucose (2-DG) as an adjunct therapy in moderate to severe Covid-19 patients.
The Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRDO), has developed the drug, 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. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty. Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid patients,” DRDO said in an official statement on Saturday.
In April 2020, during the first wave of Covid-19, INMAS-DRDO scientists had 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, DCGI Central Drugs Standard Control Organization (CDSCO) gave permission for phase-II clinical trial of 2-DG in Covid-19 patients in May 2020.
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.
“In efficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints. The drug comes in powder form in sachet, which is taken orally by dissolving it in water. It accumulates in the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production,” the statement added.
Based on successful results, DCGI further permitted the phase-III clinical trials in November 2020. The Phase-III clinical trial was conducted on 220 patients during December 2020 to March 2021 at 27 Covid-1 hospitals situated in states of Delhi, UP, West Bengal, Gujrat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu.
In 2-DG arm, significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42% vs 31%) by day-3 in comparison to SOC, indicating an early relief from oxygen therapy/dependence, the statement said.
Source: India Today