The Drugs Controller General of India has approved ananti-COVID-19 drug developed by the Institute of Nuclear Medicine and AlliedSciences (INMAS) for emergency use, the Defence Ministry has said.
An anti-Covid-19 therapeutic application of the drug2-deoxy-D-glucose (2-DG) has been developed by INMAS, a lab of the DefenceResearch and Development Organisation (DRDO), in collaboration with Dr Reddy'sLaboratories (DRL), Hyderabad.
Clinical trial results have shown that this moleculehelps in faster recovery of hospitalised patients and reduces supplementaloxygen dependence.
A higher proportion of patients treated with 2-DG showedRT-PCR negative conversion in Covid patients. The drug will be of immensebenefit to the people suffering from Covid-19.
"Pursuing Prime Minister Narendra Modi's call forpreparedness against the pandemic, DRDO took the initiative of developinganti-COVID therapeutic application of 2-DG," the ministry said in astatement on Friday.
In April 2020, during the first wave of the pandemic,INMAS-DRDO scientists conducted laboratory experiments with the help of theCentre for Cellular and Molecular Biology (CCMB), Hyderabad and found that thismolecule works effectively against the SARS-CoV-2 virus and inhibits the viralgrowth.
Based on these results, the Drugs Controller General ofIndia's (DCGI) Central Drugs Standard Control Organization (CDSCO) permittedthe Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020.
The DRDO, along with its industry partner DRL, Hyderabad,started the clinical trials to test the safety and efficacy of the drug inCOVID-19 patients.
In Phase-II trials (including dose ranging) conductedduring May to October 2020, the drug was found to be safe in Covid-19 patientsand showed significant improvement in their recovery.
Phase-IIa was conducted in six hospitals and Phase IIb(dose ranging) clinical trial was conducted at 11 hospitals all over thecountry. The Phase-II trial was conducted on 110 patients.
In efficacy trends, the patients treated with 2-DG showedfaster symptomatic cure than Standard of Care (SoC) on various endpoints.
"A significantly favourable trend (2.5 daysdifference) was seen in terms of the median time to achieving normalisation ofspecific vital signs parameters when compared to SoC," the ministry said.
Based on successful results, the DCGI further permittedthe Phase-III clinical trials in November 2020.
The Phase-III clinical trial was conducted on 220patients 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 the Phase-IIIclinical trial was presented to the DCGI.
"In 2-DG arm, significantly higher proportion ofpatients improved symptomatically and became free from supplemental oxygendependence (42% vs 31%) by Day-3 in comparison to SoC, indicating an earlyrelief from Oxygen therapy/dependence," the ministry stated.
A similar trend was observed in patients aged more than65 years.
On May 1, 2021, the DCGI granted permission for EmergencyUse of this drug as adjunct therapy in moderate to severe COVID-19 patients.
Being a generic molecule and analogue of glucose, it canbe easily produced and made available in plenty in the country.
The drug comes in powder form in a sachet, which is takenorally by dissolving it in water.
It accumulates in the virus infected cells and preventsvirus growth by stopping viral synthesis and energy production. Its selectiveaccumulation in virally infected cells makes this drug unique.
In the ongoing second COVID-19 wave, a large number ofpatients are facing severe oxygen dependency and need hospitalisation.
"The drug is expected to save precious lives due tothe mechanism of operation of the drug in infected cells. This also reduces thehospital stay of COVID-19 patients," the ministry added.