Bharat Serums secures nod to test sepsis drug on Covid-19 patients

Injectable drug is already available in the market; firm has no plans to work on vaccine candidate

Joining the list of drugs repurposed for Covid-19, a sepsis drug from Bharat Serums and Vaccines (BSVL) is getting into Phase III clinical trials.

The Mumbai-based biopharmaceutical firm — backed by US private equity player Advent International — has got approval from the drug regulator to start trials on the injectable drug that it sells under the brand U-Tryp. BSVL is not working on any Covid-19 vaccine and has no plans to do so.

Speaking to Business Standard, BSVL Managing Director and Chief Executive Officer Sanjiv Navangul said the company had approached the regulator two months back for the drug Ulinastatin. It got approval for clinical trials on patients to see if it works on Covid-19 patients with acute respiratory distress syndrome (ARDS). The clinical trials on 120 patients will start soon. He added the drug is priced around Rs 1,500 per vial. There has been 36 per cent growth in annual sales of the drug as of April, according to the AIOCD Pharmasofttech AWACS data.

“It has anti-inflammatory properties. It inhibits cytokine storm, which is a severe immune reaction wherein the body releases too many cytokines into the blood too quickly. There is clear hypothesis around this. Patients with Covid-19 develop ARDS and eventually get into mechanical ventilation. The trials will see how effective the drug is against ARDS,” said Navangul.

He added that patient recruitment for any trial takes three months. The trials are for 28 days. After that, a data analysis is conducted. It easily takes five-six months, added Navangul. The inclusion criteria for mild to moderate ARDS would mean symptoms like breathlessness. These are patients still on the ventilator. It would be a seven-day therapy for patients in the trial.

The mortality risk is higher when a patient 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, said BSVL.

Intensivists (physicians who specialise in the care of critically ill patients, most often in intensive care unit) currently use Ulinastatin in India for severe sepsis and other critical clinical conditions (acute pancreatitis). This anti-inflammatory drug can help fight Covid-19, said BSVL, as patients with severe infection can develop fatal lung damage from a cytokine storm, thanks to increase in pro-inflammatory cytokines. Navangul said it can improve the recovery time as well as reduce mortality rates. Since the drug is already sold in the market, it has an established safety profile. Once the Covid-19 trials show superior results, it can be immediately used.