Biocon’s anti-psoriasis injection Itolizumab, which was approved to treat coronavirus disease (Covid-19) on Saturday works best before a patient is put on ventilator, according to trial data released on Monday.

Older patients and those with co-morbidities such as diabetes and hypertension also recovered well after four weeks of therapy, concluded the open-label, two-arm randomized pivotal trial conducted on 30 Covid-19 patients undergoing treatment at four hospitals in Delhi and Mumbai. The median age was 51 years for patients on itolizumab and 50 years for those in the control group.

Of the 30 patients enrolled for the trial around May, 20 were on itolizumab and 10 were provided best supportive care. All 20 on the itolizumab arm recovered well; and of the 10 patients in the control group, three succumbed to the disease.

Hospitals where trials were conducted are KEM and Nair Hospitals in Mumbai, and Lok Nayak and All India Institute of Medical Sciences in Delhi.

The drug is being marketed under the name of Alzumab since 2013 for psoriasis, an autoimmune skin disorder. It is not a biosimilar but an original biologic therapy innovated in India for treating moderate to severe acute respiratory distress syndrome due to Covid-19. The drug is a monoclonal antibody, in this case, a man-made protein acting like human antibodies in the immune system.

“Why we are excited about the trial results is because this pandemic has plunged us into a humanitarian and economic crisis. This drug has a proven safety record through seven years of use. It follows an immuno-modulatory action mechanism that downgrades the cytokine storm (the body’s hyper immune response to a disease). This virus is hyperactivating our immune system that leads to organ damage, and the drug in trials has shown to start slowing down the immune response thus saving lives,” said Kiran Mazumdar-Shaw, executive chairperson, Biocon.

“30 may seem like a small number but it the minimum requirement to establish proof of concept that the drug works. We must realise that there’s an emergency situation at hand and there’s no time for conducting large trials, which is a reason why approvals are given under emergency use. But the regulatory approval is very robust,” she added.

There are three stages to Covid-19, and experts say itolisumab will have maximum benefits if it is administered in stage II when the lungs start getting affected.

“Apart from those on trial the drug has saved about 150 lives in states such as Maharashtra, Gujarat and Delhi,” said Mazumdar-Shaw.

Doctors investigating the safety and efficacy of the drug say that some of their other frontline staff that was down with Covid-19 were given the drug as part of off-label use because of the encouraging results.

“At least 20 more people took the injection with good results in our hospital. This drug is working well and has benefited almost all patients who took it,” said Dr Suresh Kumar, medical director, Delhi’s Lok Nayak Hospital.

A maximum of six doses are required for treating a patient, but most patients do not need more than four. The cost per dosage (vial) is around ₹8,000.

“The price may seem on a steeper side but what one doesn’t realise is that this drug will save the patient the cost of a ventilator bed in the ICU. Even if about three days of ICU  stay is reduced it will be cost effective in totality,” said Sandeep Athalye, chief medical officer, Biocon.

Dr Rosemary D’souza, from Mumbai’s Nair Hospital, which was one of the trial sites confirmed that the drug “ definitely decreases mortality, and also reduces time to recovery.”

Biocon is likely to conduct more trials later on a larger sample.

“Our US partners are also trying to conduct larger clinical trials based in the US which will take care of US regulatory approvals. Our first priority will be Indian market and later foreign markets. The sale will be done through a closed channel so as to ensure there’s no black-marketing of the drug.,” said Mazumdar-Shaw.