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Bharat Serums and Vaccines is looking to repurpose Ulinastatin, a medicine used to treat sepsis and acute pancreatitis, and explore if it can be used in Covid patients who show symptoms of acute respiratory distress.
The company has received the Drug Controller General of India’s approval to undertake late stage Phase III clinical trials in Covid patients showing mild-to-moderate acute respiratory distress symptoms.
The trials should begin shortly in about 120 patients in six to eight hospitals across the country, said Sanjiv Navangul, Managing Director and Chief Executive with Bharat Serums and Vaccines Limited. Data from the trial should be available by the end of the year, he told BusinessLine .
Outlining the reasons for undertaking the study, he said the drug had shown benefits in limiting factors that caused ARDS, and a meta-analysis of about 2300 patients done in China had shown positive outcomes on certain parameters.
It showed an “improvement in oxygenation index, shortening duration of mechanical ventilation, and reduced mortality and ICU stay when compared to conventional therapies”, the company said.
“The drug impacts the mortality and morbidity,” said Navangul, pointing to the key concerns around patients with serious Covid symptoms. The originator of the drug is Japanese company Mochida Pharmaceutical.
“As per the approved clinical trial protocol, subjects with mild-to-moderate Covid-19 will be randomised in the study in a 1:1 ratio with Ulinastatin and standard supportive care or standalone standard supportive care,” said Bharat Serum.
Drugs being tested
While there is no cure or vaccine to tackle Covid, there are a host of drugs being tested and developed by different companies to be used at different stages in the illness – be it the much-discussed hydroxychloroquine to remdesivir and favipiravir.
Ulinastatin is currently manufactured at BSVL’s Ambernath facility in Thane, Maharashtra. The company’s domestic revenues are pegged at about ₹700 crore and it has reasonable exports as well, the official said.
Last year, private equity firm Advent International had picked up a majority stake in the company.
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