New Delhi: Defence Minister Rajnath Singh and Health Minister Dr Harsh Vardhan on Monday released the first batch of the developed anti- COVID-19 drug, 2-deoxy-D-glucose (2-DG). Drugs Controller General of India (DCGI), the national drug regulator, had cleared the formulation on May 1 for emergency use as an adjunct therapy in moderate to severe COVID-19 patients.
The Ministry of Defence had said in a release earlier this month that 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 Dr Reddy's Laboratories.
As per the government release, the molecule helps in the faster recovery of patients hospitalised with COVID-19 and reduces their dependence on supplemental oxygen.
The release said that 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 drug will be of immense benefit to the people suffering from COVID-19," it said.
In April 2020, during the first wave of the pandemic, 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 patients.
The government said that DRDO and its industry partner, DRL, conducted phase 2 trials on 110 patients between May and October last year. 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.
The government further stated that 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.
2-DG was found to be safe in COVID-19 patients and showed significant improvement in their recovery.
The release said that 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," the release added.
The government also said that 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 by Day 3 in comparison to SoC, indicating an early relief from oxygen therapy/dependence.
It is to be mentioned that a similar trend was observed in patients aged more than 65 years.
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