The Drugs Controller General of India (DCGI) has granted permission for emergency use of anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRDO), in collaboration with Dr. Reddy’s Laboratories (DRL), Hyderabad.
An anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by INMAS, a lab of DRDO, in collaboration with Dr Reddy’s Laboratories, Hyderabad. The drug will help in faster recovery of Covid-19 patients. https://t.co/HBKdAnZCCP pic.twitter.com/8D6TDdcoI7
— DRDO (@DRDO_India) May 8, 2021
- The drug comes in powder form in a sachet, which is taken orally by dissolving it in water.
- It accumulates in the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production.
- Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
- It further said that higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID-19 patients.
- The drug is expected to be effective in patients aged more than 65 years.
- DRDO scientist Dr Anant Narayan Bhatt told ANI that the drug is expected to be effective on different variants also.
- The drug is expected to save precious lives due to the mechanism of operation of the drug in infected cells.
- This also reduces the hospital stay of COVID-19 patients.
TRIAL DATA:
The DRDO, along with its industry partner DRL, Hyderabad, started the clinical trials to test the safety and efficacy of the drug in COVID-19 patients. 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 six 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.
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.
Based on successful results, DCGI further permitted the Phase-III clinical trials in November 2020. The Phase-III clinical trial was conducted on 220 patients 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 phase-III clinical trial was presented to DCGI. In 2-DG arm, significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42% vs 31%) by Day-3 in comparison to SoC, indicating an early relief from Oxygen therapy/dependence.