DRDO responds to questions on 2-DG’s efficacy; Also launches Antibody Detection Kit for COVID-19

Amidst debate over the efficacy of the recently launched drug 2-deoxy-D-glucose (2-DG), Defence Research and Development Organization (DRDO) says that Dr Reddy’s Lab were joint development partners in the study on COVID patients. Responding to queries from the Financial Express Online, DRDO officials say, “Dr Reddy’s Lab was the development partner in this clinical study on COVID patients, as long-standing industry partners of DRDO for 2-DG clinical applications since 2004. Earlier they have successfully completed phase-3 clinical trials of 2-DG for radiotherapy of brain tumor patients.”

“Other organisations might have worked on the drug in different ways however DRDO work is based on the scientifically well-established principle that 2-DG suppresses energy generation in our cells that are infected by virus, and thereby stops viral growth in body,” DRDO official said in response to Patanjali claims.

Adding, “DRDO and Dr Reddy’s lab presented the work to DCGI and got emergency use approval as per procedure.”

As reported by Financial Express Online earlier, the commercial launch of the drug is expected in June by Dr Reddy’s Laboratories

What does DRL say?

According to the official spokesperson: “There is sufficient literature available in the public domain on 2-DG in the area of immunology/cancer therapy as it is not a new drug. In India, 2-DG has been a DRDO drug from the start. No other institute was involved in its development. The trials to test its use against COVID-19 were a collaboration between the DRDO and Dr. Reddy’s; no other institute was involved.”

The story so far …

According to an official statement issued by the Ministry of Defence (May 8, 2021), this drug has been jointly developed and produced by DRDO and Dr Reddy’s Laboratories (DRL), Hyderabad. The statement said that the drug has undergone clinical trials and it has shown that there is a faster recovery of hospitalized patients. During the trials, according to the statement, this drug helped in reducing supplemental oxygen dependence.

Sharing details of the clinical trials, the DRDO said that the trials for this drug started last year in April during the first wave of the pandemic, in which the scientists from INMAS carried out experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad.

It went on to state the molecule was working effectively against SARS-CoV-2 virus, and inhibited the viral growth. Last May, Drugs Controller General of India’s (DCGI) and Central Drugs Standard Control Organization (CDSCO) had approved the Phase-II clinical trial of 2-DG in COVID-19 patients. This Phase II was done between May-October.

The approval for the Phase III trial was given last November. And it is expected to go on until August 2021 in over 200 hospitals. Globally this drug has been tested for treating various cancers. But it is only in India that it has been tested for COVID-19 pandemic. However, the DRDO statement indicates that the Phase III trials are over and the DCGI approval has been given based on the findings.

Meanwhile, Patanjali Research Institute claims it made a strong case for its therapeutic use against COVID-19 last year.

Covid-19 Antibody Detection Kit “DIPCOVAN”

On Friday (May 21, 2021) the Defence Institute of Physiology and Allied Sciences (DIPAS), under DRDO, developed an antibody detection-based kit “DIPCOVAN”.

More about the kit

This kit can detect both spike as well as nucleocapsid (S&N) proteins of SARS-CoV-2 virus with a high sensitivity of 97% and specificity of 99%.

It has been developed in association with New Delhi based development and manufacturing diagnostics company — Vanguard Diagnostics Pvt Ltd.

This kit according to the Ministry of Defence (May 21, 2021) has been developed indigenously by the scientists and has been tested 1000 patients at various COVID designated hospitals in Delhi.

According to the note, three batches of the product were validated during the last one year and in April this year the ICMR gave its approval.

And, earlier this month the regulatory approval from the Drugs Controller General of India (DCGI), CDSCO, Ministry of Health and Family Welfare, was given to the manufacture for sale and distribution.

This kit is intended for the qualitative detection of IgG antibodies in human serum or plasma, targeting SARS-CoV-2 related antigens.

And, with a shelf life of 18 months, this kit requires just 75 minutes to conduct the test without any cross reactivity with other diseases.

When will it be available in the market?

Industry partner Vanguard Diagnostics Pvt. Ltd is expected to commercially launch the product next month. And at the time of its launch in the first week, there will be a ready stock of 100 kits (Approx 10,000 tests). The company has a production capacity of 500 kits/month soon after the launch.

And will be Rs 75 per test.

With this kit there will be a better understanding of COVID‐19 epidemiology. And will also help in assessing an individual’s previous SARS‐CoV‐2 exposure.