An anti-COVID-19 oral drug developed by the DRDO has been approved by the Drugs Controller General of India (DCGI) for emergency use as an adjunct therapy in moderate to severe coronavirus patients, the defence ministry said on Saturday.
Clinical trials of the drug 2-deoxy-D-glucose (2-DG) showed that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence, it said.
The approval to the drug has come at a time when India has been grappling with a record-breaking wave of coronavirus pandemic that has stretched the country's healthcare infrastructure to its limit. "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," the ministry said.
It said the anti-COVID-19 therapeutic application of 2-DG drug has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy's Laboratories (DRL) in Hyderabad.
"On May 01, 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 ministry said in a statement.
Adjunctive therapy is a treatment used together with the primary treatment to assist it. The drug comes in powder form in a sachet and 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," the ministry said.
In terms of efficacy trends, the ministry said, patients treated with 2-DG showed faster symptomatic cure than the 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," it said.
"Clinical trial results of the drug have shown that it 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," it added.
The ministry said the drug will be of immense benefit to the people suffering from COVID-19.
It said the DRDO started work on the project following Prime Minister Narendra Modi's call for preparedness against the pandemic early last year.
"In April 2020, during the first wave of the pandemic, INMAS-DRDO scientists conducted laboratory experiments with the help of Centre for Cellular and Molecular Biology, Hyderabad and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth," the ministry said.
Based on these results, the DCGI's Central Drugs Standard Control Organisation (CDSCO) permitted Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020.
The ministry said the DRDO, along with DRL started the clinical trials to test the safety and efficacy of the drug in COVID-19 patients.
"In Phase-II trials conducted during May to October 2020, the drug was found to be safe in COVID-19 patients and showed significant improvement in their recovery," it said. "Phase II 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," it said.
The ministry said based on successful results, DCGI further permitted the Phase-III clinical trial in November 2020.
It said 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 trial was presented to DCGI. In 2-DG arm, a significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42 percent vs 31 per cent) by Day-3 in comparison to SoC, indicating an early relief from Oxygen therapy/dependence," the ministry said.
"The similar trend was observed in patients aged more than 65 years," it said.