By Apollo 24/7, Published on - 24 May 2021
On 17th May 2021, the first batch of an indigenously developed anti-COVID-19 therapeutic drug 2-DG was formally released for emergency use in India. The launch of the drug has come at a time when the entire country is battling a deadly second wave of the pandemic. According to experts, the new anti-COVID-19 drug has the potential to be a game-changer in the fight against the virus.
Although the launch of the 2-DG drug is a welcome respite for the country, a lot of misinformation about it is circulating on social media. The article below shares all the fact-checked information that you need to know about the new anti-COVID-19 drug.
2-DG is an oral anti-viral formulation that has been given emergency approval by the Drug Controller General of India. It is an anti-COVID-19 therapeutic application of drug 2-Deoxy-D-glucose that has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a laboratory of the Defence Research and Development Organisation (DRDO), in cooperation with Dr. Reddy’s Laboratories (DRL), Hyderabad.
2-DG can only be administered upon prescription to hospitalized moderate-to-severe COVID-19 patients as an adjunct (add-on) therapy along with the existing standard of care (SOC). According to the drug makers, the formulation supports faster recovery of hospitalized COVID-19 patients and reduces their dependence on supplemental oxygen. Being a generic molecule and an analogue of glucose, 2-DG can be easily manufactured and supplied in large quantities.
The basic mechanism of the 2-DG drug involves inhibiting the glycolysis (breakdown of glucose by cells for energy) in virus-infected human cells. Viruses depend on glycolysis for their energy requirements. The energy supplied by glycolysis helps the replication of the virus in the human body. The 2-DG drug inhibits glycolysis by selectively accumulating in the virus-infected cells. By inhibiting glycolysis, the 2-DG drug disrupts the viral replication in human cells.
In April 2020, lab experiments conducted by the researchers of the Institute of Nuclear Medicine and Allied Sciences (INMAS) and Centre for Cellular and Molecular Biology (CCMB), Hyderabad, discovered that the molecule (2-Deoxy-D-glucose) is effective against the SARS-CoV-2 virus and impedes the viral growth. In May 2020, the Central Drugs Standard Control Organization (CDSCO) of the DCGI allowed phase II clinical trials to test the safety and efficacy of the 2-DG drug in COVID-19 patients.
Between May and October 2020, Defence Research and Development Organisation (DRDO) and Dr. Reddy’s Laboratories (DRL) conducted phase II trials on 110 patients. While phase II-a trials were conducted in 6 hospitals, the phase II-b (dose-ranging) trials were conducted at 11 hospitals across India. After evaluating the data of phase II clinical trials, the DCGI gave permission for the phase III trials in November 2020. The late-stage phase III trials were conducted on 220 patients admitted to 27 COVID-19 hospitals across 10 states.
The data from phase II trials found the drug to be safe in COVID-19 patients. Researchers noted that the COVID-19 patients treated with 2-DG demonstrated faster recovery than the standard of care (SoC) on various endpoints. On average, patients treated with 2-DG achieved normalization of specific vital signs parameters 2.5 days earlier than those treated only with SoC.
Similarly, the phase III clinical trial data showed that a significantly higher proportion of those who received 2-DG became free from supplemental oxygen dependence by Day 3 in comparison to those treated with SOC (42% vs 31%), thereby, indicating an early relief from oxygen therapy. A similar trend was observed in patients aged 65 and above.
According to the Indian government, the 2-DG drug will be of immense benefit to people suffering from COVID-19. Scientists who have developed the drug say that it is completely safe and effective against COVID-19. The data from clinical trials have shown that the drug can significantly improve the recovery of COVID-19 patients by reducing their dependency on supplemental oxygen. Since the drug is an analogue of the glucose molecule, it can be manufactured and made available in large quantities. However, it is important to note that the drug will not be available commercially until mid-June. Moreover, it will only be administered to hospitalized moderate-to-severe COVID-19 patients upon prescription.
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