Joining the list of drugs repurposed for Covid-19, a sepsis drug from Bharat Serums and Vaccines Ltd (BSVL) is now getting into phase-III clinical trials. The Mumbai-based company, which is backed by US private equity player Advent International, has got the approval from the country's drug regulator to start trials on the injectable drug that it sells under the brand U-Tryp.
BSVL is currently not working on any Covid-19 vaccine candidate and does not have any plans to do so.
Speaking to Business Standard, BSVL MD and CEO Sanjiv Navangul said that the company had approached the regulator about two months back for the drug ulinastatin. It got the approval for clinical trials on patients to see if it works on acute respiratory distress syndrome (ARDS) patients with Covid-19 last week. The clinical trial on 120 patients will start soon. He added that the drug is priced roughly around Rs 1,500 per vial. There has been a 36 per cent growth in annual sales of the drug as on April, according to AIOCD AWACS data.
"It has anti-inflammatory properties, and it inhibits the cytokine storm. There is a clear hypethesis around this. Patients with Covid-19 develop ARDS and eventually they get into mechanical ventilation. So, the trial will see how effective is the drug against ARDS," Navangul said.
He added that patient recruitment for any trial takes around 3 months or so, then the trial is for 28-days or so. Post that the data analysis is done. It takes five to six months easily, he said. The inclusion criteria for the trial here mild to moderate ARDS that would mean symptoms like breathlessness etc. These are patients who are not still on ventilators. It would be a five day therapy for the patients in the trial.
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, BSVL said.
Intensivists currently use Ulinastatin in India for severe sepsis and other critical clinical condition (acute pancreatitis). This anti-inflamatory drug can help in Covid19, felt BSVL, as patients with severe Covid19 infection can develop fatal lung damage from a cytokine storm thanks to increase in pro-inflamatory cytokines.
Navangul felt that it can improve the recovery time as well as reduce the mortality rates. Since the drug is already sold in the market, it has an established safety profile, and once the Covid19 trials show good results, it can be immediately used.