A potential cancer treatment drug repurposed for Covid-19 treatment– 2-deoxy-D-glucose (2-DG) – has received the Drugs Controller General of India (DCGI) nod for emergency use as an adjunct therapy for hospitalized moderate to severe Covid-19 patients.
The anti-Covid-19 therapeutic application of the drug was developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a Defence Research and Development Organisation (DRDO) lab, in collaboration with pharma major Dr Reddy’s Laboratories.
The drug, which comes in a sachet in powder form has to be taken orally by dissolving it in water. The drug works by accumulating 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. A higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid-19 patients,” INMAS-DRDO said.
According to INMAS-DRDO, the clinical trial results showed that the molecule helps in faster recovery of hospitalised patients and reduces their dependence on supplemental oxygen.
“The INMAS-DRDO scientists had conducted laboratory experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad during the first wave of the pandemic in April 2020. It was found that this molecule works effectively against the SARS-CoV-2 virus and inhibits the viral growth,” the statement read.
The Centre informed that based on the preliminary analysis, the drug was permitted Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020 which was conducted over 110 subjects.
“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 6 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,” according to the data shared by the Centre.
“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 normalization of specific vital signs parameters when compared to SOC,” it added.
Based on phase II results, DCGI further permitted the Phase-III clinical trials in November 2020 which was studied over 220 subjects taken from 27 hospitals across the country.
“The Phase-III clinical trial was conducted on 220 patients during Dec 2020 to March 2021 on a large number of patients at 27 COVID hospitals situated in states of Delhi, UP, West Bengal, Gujrat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu,” the union health ministry informed.