Mumbai-based Bharat Serums and Vaccines (BSV) gets OK to use sepsis drug for Covid clinical trials

In another instance of ‘repurposing’ an existing therapy, Mumbai-based Bharat Serums and Vaccines (BSV) has received regulatory approval to initiate clinical trials of critical care drug, Ulinastatin, for Covid-19 patients.

Ulinastatin is used in India for severe sepsis and other critical clinical conditions like acute pancreatitis. Managing director and chief executive officer Sanjiv Navangul told TOI that the company received approval from the drug regulator to conduct a clinical study on Ulinastatin, for mild-to-moderate acute respiratory distress syndrome (ARDS) patients with Covid-19.

The company joins other domestic firms including Glenmark, Sun Pharma, Biocon and NovaLead Pharma that are conducting trials of potential drugs for Covid-19. While there is no approved and proven treatment against SARS-CoV-2 virus yet, only experimental drugs are being used as supportive therapy.

Clinical trials on 120 patients are expected to start at hospitals over the next three weeks, and results will be available by December. Though there is no scientific study on Ulinastatin yet, certain countries like China are believed to have used it for Covid-19 therapy.

Ulinastatin is a “well-researched, fairly old drug”, available in the country since 2012 and manufactured by few companies including BSV. Around one million vials have been used in the country. The company’s brand, U-TRYP had sales of Rs 24 crore for the 12-month period ended April. The price of a vial is around Rs 1500 each, with the therapy expected to cost around Rs 30,000-50,000 per patient for a protocol of minimum seven days.

“There’s a good chance of the drug working on hospitalised Covid-19 patients who have breathlessness,” he said, adding the company has done seven trials in India for other indications. Ulinastatin is manufactured at the company’s facility in Thane (Maharashtra).

The mortality risk is higher when an individual with Covid-19 infection develops ARDS and pneumonia. ARDS causes dry cough, heavy breathing, breathing difficulties and increased heart rate. Ulinastatin, in such cases, can be used as a remedy to combat the underlying inflammatory condition related to ARDS in Covid-19 patients.

Meta-analysis of over 2,300 ARDS patients globally treated with Ulinastatin has shown significant improvement in oxygenation index, shortening duration of mechanical ventilation, reduced mortality and ICU stay as compared to conventional therapies, the company said.

The Rs 1,000-crore portfolio of BSV includes drugs for hormones, monoclonals, equine human serums and plasma derivatives. It is one of the major products of Japan-based Mochida Pharmaceuticals, and is also manufactured in China and Korea.