NEW DELHI: The Drugs Controller General of India (DGCI) has granted emergency use approval to an anti-Covid drug 2-deoxy-D-glucose (2-DG) developed by the Defence Research and Development Organisation(DRDO) lab. This after a three-phase clinical trial of the drug had shown a faster recovery of hospitalised patients.
The Ministry of Defence on Saturday informed that "Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. A 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-19."
The anti-COVID-19 therapeutic application of the drug 2-DG has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of the Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy's Laboratories (DRL), Hyderabad.
The work on the drug began in April 2020, during the first wave of the pandemic. INMAS-DRDO scientists conducted laboratory experiments with the help of the Centre for Cellular and Molecular Biology (CCMB), Hyderabad. The final phase III trial of the drug was conducted from December 2020 to March this year and it was found that this molecule works effectively against SARS-CoV-2 virus and inhibits its growth.
Based on these results, the DCGI's Central Drugs Standard Control Organization (CDSCO) permitted a Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020.
The DRDO, along with its industry partner DRL, Hyderabad, started clinical trials to test the safety and efficacy of the drug in COVID-19 patients. In Phase-II trials (including dose-ranging) conducted from 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 six hospitals and Phase IIb (dose-ranging) clinical trials was conducted across 11 hospitals all over the country. Phase-II trial was conducted on 110 patients.
In efficacy trends, the MoD said 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.
The Phase-III clinical trial was conducted on 220 patients between December 2020 to March 2021 at 27 COVID hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu.
The detailed data of phase-III clinical trials was presented to the DCGI. It was found that a significantly higher proportion of patients given the drug improved symptomatically and became free from supplemental oxygen dependence (42% vs 31%) by Day 3, indicating an early relief from oxygen therapy/dependence.
The similar trend was observed in patients aged more than 65 years.
On May 1, 2021, DCGI granted permission for emergency use of this drug as adjunct therapy in moderate to severe COVID-19 patients. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country.
The drug comes in powder form in a sachet, which is taken orally by dissolving it in water. It accumulates in the virus-infected cells and prevents the growth of the virus by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique.
In the ongoing second COVID-19 wave, a large number of patients are facing severe oxygen dependency and need hospitalisation. The drug is expected to save precious lives due to the mechanism of operation of the drug in infected cells. This also reduces the hospital stay of COVID-19 patients.