India has approved 2-deoxy-2-glucose (2-DG), a drug which helps in reducing dependency on oxygen among hospitalised COVID-19 patients, as additional therapy to fight COVID-19. This drug produced by the Defence Research and Drug Organization (DRDO) was approved by the Drug Controller General of India on May 8 and was launched by the Minister of Health and Family Welfare, Dr. Harsh Vardhan as well as Minister of Defence, Rajnath Singh on May 17.
Manufactured 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), there is no pre-print or published study suggesting that 2-DG plays an active role in curbing SARS-CoV-2 and decreasing supplemental oxygen dependence of hospitalised patients. Neither the DRDO nor DRL have shared the detailed results of the clinical trials discussed in the press release. The medicines are expected to be available in the markets soon.
The researchers observed that close to 42% of the 220 participants improved and their oxygen dependence decreased faster in comparison to patients who received the prescribed standard of care issued by the Ministry of Health and the Indian Council of Medical Research. These Phase III trial results led to the DCGI approving this drug for Emergency Use as an additional therapy to the existing standard of care.
This drug that is a form of glucose will be manufactured in sachets. The medicine is supposed to be consumed after emptying the contents of the sachet in water along with the regular prescribed medicines. This medicine has been approved for patients exhibiting symptoms of moderate to severe COVID-19.
This is the first time that 2-DG which has been studied in several in-vitro and animal studies has been approved to be used against an organism. In-vitro studies are wherein a specific tissue or organ is acted on by the drug in either a test-tube or a culture.
What is 2-DG
The approved drug 2-deoxy- D-glucose inhibits the breakdown of glucose to form ATP molecules which provide cells in the body with energy. This drug also hampers cells from proliferating as well as their growth. This drug has helped in reducing the growth of cancerous tumours in the body in clinical trials but also caused prolonged cardiac side-effects.
This therapy has been studied for tumours as well as epilepsy but has never been approved before to be used as treatment for any of the diseases.
Role of 2-DG Against SARS-CoV-2
In the absence of a detailed pre-print or published paper describing the rationale and methodology, it is difficult to ascertain the exact chemical and therapeutic effect of 2-DG on SARS-CoV-2.
When contacted by BOOM, DRDO responded that the paper will be published soon without giving a definite date for the same.
BOOM also contacted the DRDO to understand the reason for researching 2-DG's effect on SARS-CoV-2. "2-DG is a glucose analogue that is taken up by cells just like glucose. Difference is that 2-DG enters the cells but does not produce energy. In virus-infected cells, need for glucose increases multifold. Hence 2-DG also accumulates at much higher quantity. This restricts energy production and inhibits virus growth. Hence DRDO started working on this molecule for countering Covid-19," a spokesperson said.
A liver specialist, Dr. Cyriac Abby Philips, at Rajagiri Hospital in Kerala, however, pointed that there could be neurological side-effects of the high-level of glucose. ""Cancer cells depend heavily on glucose for their survival and hence by tagging them with 2DG we can restrict cancer cell growth. Similarly, it can also affect high glucose utilising normal cells like brain cells (neurons) and could cause brain related side effects."
The published research so far discusses the effect of this medicine against the virus in-vitro. A September 2020 studied on the effect of 2-DG on SARS-CoV-2 infected monocytes and macrophages- white blood cells and cells helping in building innate immunity, showed that the drug effectively stopped the metabolism and growth of the virus in these cells. Another November 2020 study uses 2-DG with radiation therapy on COVID-19 infected cells to control the cytokine storm that was being witnessed in patients.
The DRDO as well as DRL are yet to release their data of the Phase II and Phase III trials of the drug which is expected to flood the markets in the next week. This is the first study which studies the impact of the drug in humans.