New Delhi: The Narendra Modi government’s expert panel has asked pharmaceutical company Dr Reddy’s Laboratories to conduct phase 3 clinical trial of a potential cancer drug after it showed efficacy on Covid-19 patients in the phase 2 trial.
The drug, 2-Deoxy-D-Glucose oral powder, also called 2-DG, works by preventing the supply of glucose molecules to the cancerous cells, which need glucose for survival. With the drug stopping the glucose supply, the cells start dying. The drug is, however, not yet approved for cancer treatment.
Hyderabad-based drugmaker, Dr Reddy’s, presented the results of the phase 2 trials of the drug before the Modi government’s subject expert committee (SEC), which advises the apex regulator, Drug Controller General of India, on applications seeking approvals for new drugs, vaccines, and clinical trials.
However, the panel found the sample size “inadequate” for approving the drug for marketing in India.
The decision to start phase 3 trials was made following detailed deliberations, according to the minutes of the SEC meeting held on 13 October.
The phase 2 trials of the 2-DG drug were sponsored by Dr Reddy’s along with the Institute of Nuclear Medicine and Allied Sciences, a department functioning under the Defence Research and Development Organisation.
“The sponsor of this study, INMAS, DRDO, Ministry of Defence, Government of India, was responsible for genesis of this hypothesis and testing of efficacy of 2-DG against SARS-CoV-2,” the company said during the registration of the phase 2 trials on the Clinical Trials Registry, a portal where all clinical trials undertaken in India are registered.
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Discussions of the panel
According to the minutes of the meeting, uploaded on the Central Drugs Standard Control Organisation’s website, the SEC panel opined that the results of the phase 2 study are positive and the drug has shown efficacy against Covid.
“In the phase 2b dose finding study, the results have shown efficacy with optimum dose of 90 mg/kg,” the panel noted.
However, it opined that “the sample size was small in the phase 2 study for grant of market authorisation”. The drug was tested on 40 patients during the trial.
The panel, after detailed deliberation, recommended that “the firm should submit phase 3 clinical trial protocol with adequate sample size and clearly defined inclusion-exclusion criteria, primary and secondary endpoints”, among other mandatory requirements.
Working of the drug
According to Dr Reddy’s note uploaded on the Clinical Trials Registry on the working of the drug, 2-DG is an inhibitor of glucose transport and glycolysis, and is known to inhibit the growth of neoplastic cells in vitro (in tube) and in vivo (in organisms).
While 2-DG is not an approved drug, “it has been studied in 218 clinical trials for the treatment of various cancers globally,” the company claimed.
The drug has, however, not been evaluated in the acute treatment of moderate to severe Covid-19.
“However, based on mechanistic and in-vitro-evidence as well efficacy seen in the interventional clinical studies in malignancies and genital herpes, the sponsors believe that 2-DG could be developed for the specific treatment of patients with Covid-19 disease in conjunction with other antiviral therapies,” the company said.
Dr Reddy’s, according to the CTRI registration, believes that high accumulation of 2-DG in inflamed lung tissue of Covid-19 patients could stop replication of the novel coronavirus.
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