Over 10,000 doses of the 2-DG drug, which comes in powder form and is taken orally by dissolving it in water, were launched on Monday.
The anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad.
It was approved for emergency use as an adjunct therapy in moderate to severe COVID-19 patients by the Drugs Controller General of India (DCGI) on May 1.
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.
Back in April 2020, during the first wave of the coronavirus in India, the 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 these results, the DCGI Central Drugs Standard Control Organization (CDSCO) permitted Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020.
The DRDO, along with its industry partner DRL, Hyderabad, started the clinical trials to test the safety and efficacy of the drug in coronavirus patients and during 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.
This is to be noted that 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.
According to the Ministry of Defence, in efficacy trends, the patients treated with the 2-DG drug 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 which 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.
Subsequently, the detailed data of the phase-III clinical trial was presented to DCGI.
In the 2-DG arm, a 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.
A similar trend was observed in patients aged more than 65 years.
“Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country,” the Ministry of Defence stated on May 8.
The drug 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.
2-deoxy-D-glucose also reduces the hospital stay of COVID-19 patients and is likely to play a key role in India’s fight against the second wave of COVID-19.