Updated: June 8, 2021 10:05:39 am
The national drug regulator, Drugs Controller General of India (DCGI), had cleared the formulation on May 1 for emergency use as an adjunct therapy in moderate to severe Covid-19 patients.
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2-DG has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), New Delhi, a lab of the Defence Research and Development Organisation (DRDO), in collaboration with Hyderabad-based pharma company Dr Reddy’s Laboratories (DRL), the Ministry of Defence had said in a release earlier this month.
How it works
According to the government release, clinical trial data show that the molecule helps in faster recovery of patients hospitalised with Covid-19, and reduces their dependence on supplemental oxygen.
The drug accumulates in 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, the release said.
“The drug will be of immense benefit to the people suffering from Covid-19,” it said.
During the first wave of the pandemic in April 2020, laboratory experiments carried out by scientists of INMAS-DRDO in collaboration with the Centre for Cellular and Molecular Biology (CCMB), Hyderabad, found that this molecule works effectively against SARS-CoV-2, the coronavirus that causes the Covid-19 disease, and inhibits viral growth.
In May 2020, the Central Drugs Standard Control Organization (CDSCO) of the DCGI permitted phase 2 clinical trials of 2-DG in Covid-19 patients.
DRDO and its industry partner, DRL, conducted phase 2 trials on 110 patients between May and October last year, the government said. Phase 2a was conducted in six hospitals, and phase 2b (dose ranging) was conducted at 11 hospitals across the country.
On the basis of successful phase 2 clinical trials data, DCGI permitted phase 3 clinical trials in November 2020. Between December 2020 and March 2021, late stage trials were carried out on 220 patients admitted to 27 Covid hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu, the government said.
The phase 2 clinical trials were carried out to test the safety and efficacy of the drug in Covid-19 patients. 2-DG was found to be safe in Covid-19 patients, and showed significant improvement in their recovery, the government release said.
In efficacy trends, “the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints”, the release said.
“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.”
Data from the phase 3 clinical trial showed that 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”, the government said.
A similar trend was observed in patients aged more than 65 years.
According to the government, 2-DG being a generic molecule and an analogue of glucose, it can be easily produced and made available in large quantities.
The drug is available in powder form in a sachet, and can be taken orally after dissolving in water.
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