First batch of DRDO's anti Covid-19 drug 2-DG released
2-DG helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence
The first batch of the 2-deoxy-D-glucose (2-DG) drug developed by the Defence Research and Development Organisation (DRDO) for treatment of Covid-19 was released on Monday.
The first and second batch of the drug, formally released by Defence Minister Rajnath Singh, will be used in a limited manner and will be available in all hospitals from June onwards.
2-DG had received clearance for Emergency Use 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 moderate to severe COVID-19.
The drug, developed by DRDO in collaboration with Dr Reddy's Laboratories (DRL), 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 virus growth 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.
Defence Minister Singh expressed his confidence in the effective use of the drug. He said that the drug is a big example of India’s scientific prowess; he congratulated DRDO and the research and development department of the drug.
Further, Singh said that the 2-DG drug is like a ray of hope amid the second wave of the pandemic; however, he said that the country should still keep up with its preparation and not rely solely on this drug.
The Defence Minister handed over the drug to Union Health Minister Harsh Vardhan Singh who in turn handed it over to Delhi AIIMS Director Randeep Guleria.
"This drug may be our first indigenous research based outcome to fight against the pandemic. It will reduce the recovery time and oxygen dependency,” Vardhan said.
“Not just for India but I hope it serves in the fight against the pandemic globally in the coming days," he added.
One year of development and clinical trials
DRDO took the initiative of developing anti-COVID therapeutic application of 2-DG during the first wave of the pandemic.
In April last year, INMAS-DRDO scientists 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 viral growth.
Based on these results, the Drugs Controller General of India's (DCGI) Central Drugs Standard Control Organization (CDSCO) permitted Phase-II clinical trials 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 COVID-19 patients. 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 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.
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 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 per cent vs 31 per cent) 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.
On May 1 this year, 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.