The Drugs Controller General of India (DCGI) has granted emergency use authorisation for a new drug, 2-deoxy-D-glucose (2-DG), as adjunct therapy that can help lower supplemental oxygen dependence in moderate to severe Covid-19 patients.
India’s Defence Research and Development Organisation (DRDO) lab Institute of Nuclear Medicine and Allied Sciences (INMAS) developed the drug in alliance with Dr Reddy’s Laboratories (DRL).
The drug is available in powder form and can be dissolved in water for oral administration.
According to clinical trial data, the therapeutic led to faster recovery of hospitalised patients and lowered need for supplemental oxygen. Majority of Covid-19 patients on the drug had RT-PCR negative conversion.
In April last year, researchers at INMAS-DRDO studied 2-DG in laboratory, in collaboration with Centre for Cellular and Molecular Biology (CCMB), Hyderabad. These experiments showed that the molecule works effectively against the Covid-19 virus and supresses its growth.
Based on these data, DCGI’s Central Drugs Standard Control Organization (CDSCO) allowed Phase II Covid-19 trial of the drug in May last year.
The Phase II trial, in a total of 110 Covid-19 patients, assessed the safety and efficacy of the drug, which was found to be safe and led to significant improvement in their recovery.
Phase IIa was carried out in six hospitals while Phase IIb dose ranging study was performed at 11 hospitals across India.
Efficacy data revealed quicker symptomatic cure with 2-DG versus standard of care (SoC) on different endpoints. Also, the drug had favourable trend on the median time to normalisation of certain vital signs parameters compared to SoC.
The Phase III trials of the drug were started in November last year and involved 220 patients at 27 Covid-19 hospitals in India.
Results demonstrated symptomatic improvement and freedom from supplemental oxygen dependence by day 3 in higher proportion of patients on 2-DG, versus SoC, representing an early relief from oxygen therapy.
The data was similar in patients aged more than 65 years.
In a separate development, Pfizer and BioNTech have initiated a Biologics License Application (BLA) seeking complete approval from the US Food and Drug Administration (FDA) for their mRNA Covid-19 vaccine in people aged 16 years and above.
Meanwhile, the European Medicines Agency (EMA) has begun a rolling review of data on GlaxoSmithKline (GSK) and Vir Biotechnology’s sotrovimab to treat Covid-19 patients aged 12 years and over who do not need oxygen supplementation but may progress to severe disease.