Wednesday, June 16, 2021

Govt rolls out DRDO-formed Covid drug, experts call for more research

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Defence minister Rajnath Singh on Monday launched an anti-Covid drug developed by the Defence Research and Development Organisation (DRDO) in collaboration with Hyderabad-based Dr Reddy’s laboratories (DRL), calling it “a new ray of hope in these challenging times”, although experts called for more scientific data.

The oral drug 2-DG (2-deoxy-D-glucose) was approved by the Drugs Controller General of India (DCGI) on May 8 as an adjunct therapy – one that supplements regular treatment – for Covid-19. DRDO and its partner DRL carried out a phase II trial with 40 volunteers last year and a phase III trial with 220 in 2021, according to the filings on the Clinical Trials Registry – India.

Assessments from neither have been shared yet and it was not clear from which trials the DRDO officials were determining their efficacy assessments.

“The peer-reviewed research is expected to be published soon,” a senior DRDO official said, asking not to be named.

The registries also did not report in what proportion volunteers were randomised to be given 2-DG or the standard Covid care.

Defence minister Singh, who handed over the first batch of the drug to Union health minister Harsh Vardhan said the drug would reduce oxygen dependency and help patients recover sooner, citing the unreleased trial findings.

One box each of the drug sachets was also handed over to All India Institute of Medical Sciences (AIIMS) director Dr Randeep Guleria and Lieutenant General Sunil Kant of Armed Forces Medical Services (AFMS). The drug will be made available for emergency use at different hospitals across the country, the defence ministry said in a statement.

“The development and production of the drug is a shining example of public-private sector partnership to help the nation in these challenging times,” the defence minister said. He added that the drug was a perfect example of India’s scientific prowess and a milestone in the efforts towards self-reliance.

“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,” the defence ministry said in statement on May 8.

“It was an adaptive phase II/III trial that was conducted to determine safety and efficacy of this drug in Covid-19 patients. The drug was originally meant for treating cancer patients and then tried in Covid-19 patients with a modified dosage. The trial results were promising as it showed reduction in viral load as it impedes viral replication; length of hospitalisation also reduced; and it also reduces steroid and oxygen requirement,” said Dr Akshay Budhraja, from the respiratory medicine department at Delhi’s Aakash Healthcare Super Speciality Hospital, which was one of the trial locations. Dr Budhraja was one of the trial investigators.

Experts said such announcements must be accompanied with evidence. “I am not commenting on the efficacy of the drug, all I ask for is the evidence. You cannot create false hopes as you would stop patients from taking real medicines. It is not a good scientific practice to do trials and sit on the data. Trial data should ideally be published in peer-reviewed top journals so that those people who are not a part of the clinical trial can study it, question it and cross-check the legitimacy of the trial,” said CM Gulhati, editor, Monthly Index of Medical Specialities (MIMS), pharmaceutical reference guide.

“I think we are really getting overactive in terms of approvals and that is not good for medical science as people who conduct clinical trials have vested interest in showing positive trial results,” he said. “And everything is online these days; how much time will it take to put stuff online for people to scrutinise a claim?” he added.

The drug 2-deoxy-D-glucose has been used for decades as a possible cancer therapy as research has shown that it hampers cell growth by blocking cellular glucose supply, leading to its use as a tumor therapeutics. The hypothesis in its use in treating Covid-19 is that it could impair replication of Sars-Cov-2 by a similar mechanism of action.

The drug has still not been approved by regulators for regular cancer therapy.

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