Biocon's Drug Trial Not Good Enough For COVID-19 Mortality Reduction: ICMR

After the Indian Council of Medical Research (ICMR) allowed the emergency use of the two drugs Itolizumab and Tocilizumab to treat COVID-19 patients, the Director-General of the medical body, Balram Bhargava, has acknowledged that there is no evidence from clinical trials of the two drugs that it reduces death among severely ill COVID-19 patients, The Hindu reported.

The drugs are lab-cloned antibodies, developed by Bangalore-based pharmaceutical company Biocon Limited led by entrepreneur Kiran Mazumdar Shaw. They were approved for emergency use in India last month by ICMR after a randomised clinical trial.

On Monday, Biocon at a press conference confirmed that results of the Phase-II study of Itolizumab - a drug basically used to cure basically skin disorder psoriasis, showed significant results in reducing mortality among moderate to severe ARDS (acute respiratory distress syndrome) patients hospitalised with COVID-19.

The next day, Balram Bhargava at a Health Ministry press briefing said that the two Biocon drugs have been taken into consideration to prevent cytokine storms, however, they have not demonstrated any signs of mortality reduction in the trials, and therefore, the trial will be conducted in different parts of the world to check the drug's veracity.

Speaking on the efficacy of the Itolizumab drug, Kiran Mazumdar Shaw told the media that pivotal data showed reduction 'but might need Phase IV trials to support the result.'

The issued press release by Biocon about the confirmation of emergency use of the drug, did not have any data or a scientific paper from a Phase-II clinical trial the company said it conducted in three cities.

Infact, the drug trial has reportedly been conducted only on 31 patients.

Dr Jammi Nagaraj Rao, an epidemiologist based out of the UK wrote an article for The Wire Science, where he stated that the trial was extremely deficient in design.

"Its defects, particularly the extremely small sample size – largely invalidate the claims made in the press release from Biocon," the article read.

Rao further said that the company has not published the data that would allow independent experts to assess their claim in the press release, about the drug being useful in reducing that mortality rate. With such limited information and without further larger trials, it is difficult to see how the company can fulfil its ambition to take this therapy to other parts of the world.

"The irony is that Itolizumab may well be a breakthrough. If it is and if it's real effects can be shown conclusively in a large trial, then Biocon would be able to boast of an unbeatable product. As things stand, it is unlikely to make that breakthrough without much greater rigour in the science of clinical trials," the article read.

According to the media, the details provided by the company failed to convince independent scientists about its effectiveness, however, the press release and Shaw quoted the data as 'compelling'.

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