Scanty data raise doubts on 2-DG drug for Covid-19 treatment

Doctors involved in the fight against Covid-19 have reportedly taken a cautious stance on the 2-DG drug approved by the Indian drug regulator for emergency use that claimed it reduces recovery time and oxygen dependency for coronavirus patients, citing inadequate publicly available data on the clinical trials.

Top doctors have said the anti-Covid oral drug, jointly developed by the Defence Research and Development Organisation (DRDO) and Dr. Reddy’s Laboratories, shows initial promise as the principle behind its use is well established, but there is need for more proof from clinical trials that it can be used widely, The Indian Express reported.

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The 2-DG has until now been used as an unapproved cancer drug to inhibit glycolysis—one of the ways through which cells break down glucose in the body—which helps viruses get energy to replicate and spread. Preventing this process should theoretically slow down the Covid-19 virus, experts say.

While German, Brazilian and US scientists have published papers last year on the possible use of 2-DG as a treatment for Covid-19, none of them are based on testing in on-ground hospital settings. The version of the drug rolled out in India has its grounding in a research paper written in March last year by a group of scientists mainly from the Patanjali Research Institute in Haridwar and has not been peer reviewed.

Multiple attempts by Dr. Reddy’s in the last year that sought swift approval with shortened trials were shot down by the DGCI’s Subject Experts Committee, the expert panel of the Indian drug regulator, citing insufficient human testing. The regulator then granted approval to the drug after phase 2 and 3 clinical trials were conducted.

Many top doctors remain circumspect about the indiscriminate use of the drug without enough data being available in the public domain.

“I would only use it in research mode till we have data in the public domain. Studies have not been done in the population of diabetics and those with coronary artery disease. It may be useful in mild to moderate disease after validation in research mode,” Dr Shashank Joshi, expert member in the Maharashtra Covid task force, told the publication.

Sumit Ray, head of critical care at Holy Family Hospital in New Delhi echoed Joshi’s sentiments, saying that he would not include it in his treatment of Covid-19 patients for the moment as the developers have not shown any significant clinical outcomes yet.

The Ministry of Defence said in a press release on May 8 that the drug had been tested on 110 patients in Phase 2 trials but Dr. Reddy’s June 2020 listing of this Phase 2 trial mentions a sample size of only 40 participants.

Phase 3 clinical trials of the drug were conducted on 220 patients between December 2020 to March 2021 at 27 Covid hospitals. Although 2-DG was authorised on May 1, the Central Drugs Standard Control Organization (CDSCO) has not made the minutes of the SEC meeting, where emergency authorisation was recommended, public as yet.