Bengaluru-based Biocon Limited’s Itolizumab drug that was granted emergency use approval for treating Covid-19 patients was cleared on the basis of a randomised clinical trial of just 30 patients across four centres, the company revealed on Monday.
Itolizumab is an existing drug used to treat skin ailment Psoriasis. The Drug Controller General of India (DCGI) approved its restricted emergency use on Saturday.
The company already markets the drug as ALZUMAb and one vial will cost Rs 8,000. According to Biocon’s own admission, typically, one full course of ALZUMAb therapy will cost patients Rs 32,000 as four vials are needed.
The company has claimed the clinical trials met the primary endpoint of reducing mortality and other key endpoints of improved oxygen levels and reduction in hyper-inflammation in the body.
To back its claim, the company sought to point out that of the 30 patients, 20 patients who were in the interventional arm of the trial or those who got Itolizumab, showed significant improvement in their condition and no mortality occurred in this arm of the trial.
In the other arm of the randomised trial where patients were given standard care, comprising antivirals, hydroxycholoroquine and oxygen therapy, three of the 10 patients died and seven survived.
The company, however, has not shared any data yet in public domain through a peer-reviewed paper.
Data shared by the company’s top officials and data available on Clinical Trials Registry website showed that clinical trials to test the efficacy of the drug began in May.
The trials were carried out at Lok Nayak Jai Prakash Narayan Hospital and All India Institute of Medical Sciences in Delhi and at King Edward Memorial (KEM) Hospital and BYL Nair Hospital in Mumbai.
Nanavati Hospital, which was listed as one of the trial sites, could not enroll any patient, a doctor from the hospital aware of developments said.
“Apart from 20 patients who recovered, many doctors and investigators in many parts of the country decided to use Alzumab available in the market in a bid to try and save patients. So far, over 150 patients have been rescued with Itolizumab or Alzumab in Maharashtra, Gujarat and Delhi,” said Biocon’s Executive Chairperson Kiran Mazumdar-Shaw.
Dr Suresh Kumar, Medical Director of Lok Nayak Hospital, told News18, “We had enrolled 11 patients for the trial. The results are encouraging. All the deaths happened in the control group. In the experimental group, there were no deaths, they showed good improvement.”
Criticism of Low Numbers in Clinical Trials
Due to the low numbers of enrollment in the clinical trials, some in the scientific community have raised questions on the approval granted for its emergency use.
On Monday, during a webinar briefing of Biocon, the company’s top officials were asked about this criticism.
Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics, said, “It is a label extension of an existing product. We have a lot of safety information over the last seven years. If we had not seen this magnitude of effect in reducing mortality, even in a small trial, then we would have expanded the trials. We have demonstrated the statistically significant differences and the regulators were convinced that the magnitude of effect is high.
Dr Shashank Joshi, the principal investigator of the trial and dean, Indian College of Physicians, said, “In a pivoted trial, when we want to answer a question, the minimum statistical number required is 30, and therefore, lot of people lot might still critique that 20 and 10 is too small a number. Yes, I agree with that, but as long as you apply a robust statistical design where Phase II and III has already been tried in 2013 on more than 500 patients, I think it gives us a proof of concept whether it is working or not. This small trial has given us insights on safety and efficacy.”