Anti-COVID drug developed by DRDO for emergency use gets approved

An anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS).

INMAS, a Defence Research and Development Organisation (DRDO), has along with Dr Reddy’s Laboratories (DRL), Hyderabad have developed this drug, which already undergone clinical trials, in which this molecule helps in faster recovery of hospitalised patients. And this also helps in reducing supplemental oxygen dependence. The initiative to develop anti-therapeutic application of 2-DG was initiated after Prime Minister Narendra Modi’s call.

According to an official statement issued by the Ministry of Defence on Saturday (May 8, 2021), a large number of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients.

When did the process start?

It started last year in April during the first wave of the pandemic. The scientists from INMAS carried out experiments in the laboratories with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad.

During the experiments it was discovered that the molecule was working effectively against SARS-CoV-2 virus. And, also, inhibits the viral growth.

In May 2020, based on the experimental findings, Drugs Controller General of India’s (DCGI) Central Drugs Standard Control Organization (CDSCO) allowed the Phase-II clinical trial of 2-DG in COVID-19 patients.

With its industry partner DRL, Hyderabad, INMAS-DRDO started the clinical trials. These tests were carried out to test the safety and efficacy of the drug on the patients.

Phase II Trials

This phase included dose ranging and was conducted between May-October 2020. And, this drug was found to be safe, and there was improvement in the recovery of the patients.

The Ministry of Defence statement states that the Phase II(a) was conducted in six hospitals and Phase II (b ) (dose ranging) clinical trial was conducted at 11 hospitals across the country. And, in Phase-II trial 110 patients were involved.

Efficacy Trends

All the patients who were treated with this showed faster symptomatic cure compared to the Standard of Care (SoC) on various endpoints.

In terms of the median time to achieving normalisation of specific vital signs parameters when compared to SoC, a favourable trend was seen (2.5 days difference).

The Phase III clinical trials were allowed last November based on these results. And 220 patients were part of the trials between December 2020 to March 2021 at 27 COVID hospitals. These hospitals were located in Delhi, Maharashtra, Andhra Pradesh, Telangana, Karnataka, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, and Tamil Nadu. The data gathered was then presented to the DCGI.

The detailed data of phase-III clinical trials was presented to DCGI.

Giving details about the findings, the statement adds, “In 2-DG arm, a large number of patients improved symptomatically. And, they became free from supplemental oxygen dependence (42% vs 31%) by Day-3. This was in comparison to SoC, indicating an early relief from Oxygen therapy/dependence.

On patients above 65 years, a similar trend was observed. And, earlier this month, (May 01, 2021) permission has been given by the DCGI for `Emergency Use’ of this drug as adjunct therapy in moderate to severe COVID-19 patients.

Since it is a generic molecule and analogue of glucose, this can be easily produced and made available in bulk in the country.

Form of the Drug

It comes in powder form in a sachet and can be taken orally by dissolving in water.

How does it help?

According to DRDO, once it goes into the system it selectively accumulates in the virus infected cells and stops the growth of the virus by stopping energy production and viral synthesis.

Since in the second wave the patients are facing severe oxygen dependency, this drug will help.