Bangalore-based Biocon on Monday released what it said were “compelling” clinical trial results indicating that itolizumab, a drug the firm manufactures, can reduce the need for ventilator support and the risk of death in Covid-19 patients.

Each of 20 patients with moderate to severe Covid-19 who had received the drug under the clinical trial had survived while three of 10 patients who had received the best supportive care but not itolizumab died, senior Biocon executives and doctors involved in the trial said.

The Central Drugs Standard Control Organisation, India’s drug regulatory authority, had on Friday approved the restricted emergency use of itolizumab in the treatment of moderate to severe Covid-19 after assessing the trial data.

Some doctors have raised concerns about the CDSCO approving the drug after a trial involving only 30 patients, but company executives and clinical trial investigators have argued that emergency situations justify “small but pivotal trials”.

“We believe that even with a small number, we have compelling results that demonstrate that itolizumab can significantly reduce mortality in Covid-19,” Sandeep Athalye, Biocon’s chief medical officer, told The Telegraph.

He had earlier said in a media release: “In addition to these encouraging trial results, we have also seen similar promising efficacy in over 150 patients treated (with itolizumab) under compassionate use by doctors.”

Biocon had, after in-house research, released itolizumab in 2013 for use in the chronic skin disorder called psoriasis. Researchers say the drug has an anti-inflammatory action that prevents a complication called a cytokine storm release in patients with severe Covid-19.

“We’ve continued to use the drug on our Covid-19 patients after the trial,” said Rosemarie deSouza, a senior physician at Mumbai’s Nair Hospital, one of the four trial sites.

Suresh Kumar, another trial investigator who is medical director at the Lok Nayak Jai Prakash Narain Hospital, New Delhi, said the results suggested that itolizumab could protect moderate to severe Covid-19 patients from the need for ventilator support.

The drug will be made available to patients at Rs 32,000 for a standard course of treatment, which will include four vials at Rs 8,000 each, Biocon said.

“This should be considered cost-effective as it promises to reduce intensive care unit stay by three to four days,” said Vishal Gore, a physician and critical-care specialist in Solapur, Maharashtra, who has used the drug on several patients outside the clinical trial.

Doctors say that over 85 per cent of Covid-19 patients will not require itolizumab, which is to be given only to patients who appear heading into a cytokine storm.

“When a patient’s oxygen requirement increases, fever spikes again, or blood chemistry suggests an imminent cytokine storm – that’s the point we intervene,” Kumar said.

Gore and other doctors said that itolizumab works somewhat similarly to another anti-inflammatory drug called tocilizumab, which too is being used in Covid-19 patients with the aim of suppressing the cytokine storm release.

“But it (tocilizumab) is more expensive than itolizumab,” Gore said.

The approval for itolizumab comes at a time India's Covid-19 epidemic continues to grow exponentially. The country recorded 28,701 new Covid-19 cases on Monday, raising the number of patients to 878,254, of whom 301,609 are under medical supervision, 553,471 have recovered, and 23,174 have died.

Biocon executives said the company was planning a larger clinical trial. The company did not respond to queries about its current production capacity and how many patients it can currently support per month.

“We have the manufacturing capacity and the supply and distribution network in place. However, after this approval, we are looking to ramp up production capacity to meet the expected surge in demand,” a company spokesperson said.

Not all doctors are impressed by the trial results.

“In any trial, we need enough patients to detect the difference between the two arms - those who received the drug and those who did not,” said Shri Prakash Kalantri, professor of medicine at the Mahatma Gandhi Institute of Medical Sciences, Wardha.

“We need a larger study to generate robust evidence for efficacy. A study would typically require a few hundred patients. The study on the anti-viral remdesivir in the US, for instance, had enrolled over 1,000 patients.”

While the results from the sample of 30 patients are statistically significant, Kalantri said the significance was relatively “fragile”.

A fragility index calculator, for instance, applied to this trial suggests that if one patient in the experimental group had died, the study would lose its statistical significance.

Anant Bhan, a bioethics specialist and adjunct faculty at the Centre for Bioethics at the Yenepoya University in Mangalore, said he shared these concerns.

“The available data might not be enough to make a decision on clinical efficacy,” he said, arguing for efficacy assessment in more patients.

Biocon said the company’s commercial partner in the US, Canada, Australia and New Zealand was “moving quickly” to initiate a global study of itolizumab that would support the approval of the therapy in the US and elsewhere.

The idea is that “the therapy may become available in the shortest possible time to the greatest number of patients worldwide”, it said.