New Delhi: On Monday, the first batch of anti-COVID drug 2-DG, developed by the DRDO, will be released by Defence Minister Rajnath Singh and Health Minister Harsh Vardhan. Around 10,000 doses will be distributed to some hospitals in the national capital.
The drug developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS) which is a lab of the Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy's Laboratories (DRL), Hyderabad.
Earlier this month, the defence ministry said, the DGCI approved the oral drug, drug 2-deoxy-D-glucose (2-DG), for emergency use as an adjunct therapy in moderate to severe coronavirus patients. The approval of the drug came at a time when India is grappling with a record-breaking wave of the coronavirus pandemic that has stretched the country's healthcare infrastructure to its limit.
On May 8, the defence ministry said the clinical trials of the drug, 2-deoxy-D-glucose (2-DG), showed that it helps in a faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
The drug is in a powder form in a sachet, which is taken orally by dissolving it in water. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country.
How the drug 2-deoxy-D-glucose works
It accumulates in the virus infected cells and prevents virus growth by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique.
"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 ministry stated according to IANS. Similar trend was observed in patients aged more than 65 years.
Drug trials began in 2020
In April 2020, INMAS-DRDO scientists conducted laboratory experiments with the help of the Centre for Cellular and Molecular Biology (CCMB), Hyderabad and found that this molecule works effectively against the SARS-CoV-2 virus and inhibits the viral growth.
Based on the experiment's results, the DCGI's Central Drugs Standard Control Organization (CDSCO) permitted the Phase-II clinical trial in COVID-19 patients in May 2020.
The Phase-II trial was conducted on 110 patients between May & October 2020. Phase-IIa was conducted in six hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country, during which it was found to be safe in Covid-19 patients and showed significant improvement in their recovery. In the efficacy trends the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints.
Between December 2020 to March 2021 the Phase-III clinical trial was conducted on 220 patients at 27 Covid hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu. The detailed data of the Phase-III clinical trial was presented to the DCGI.