India-based Bharat Serums and Vaccines (BSVL) has secured regulatory approval to assess sepsis drug, Ulinastatin, in Phase III clinical trial to treat Covid-19.
Set to commence soon, the trial will involve approximately 120 patients who have mild to moderate symptoms of acute respiratory distress syndrome (ARDS). The study is expected to run for 28 days, with data available potentially by the end of the year.
The drug is expected to improve recovery time and also mitigate mortality rates.
BSVL managing director and CEO Sanjiv Navangul was quoted by Business Standard as saying: “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.”
Meanwhile, The Hindu BusinessLine noted that the drug was chosen based on certain positive outcomes in a meta-analysis conducted in 2,300 patients in China.
Results showed that Ulinastatin improved oxygenation index, shortened duration of mechanical ventilation and decreased mortality and ICU stay compared to standard therapies.
Bharat Serums joins the list of Indian companies that have been working on drug candidates for the treatment of Covid-19 infection.
Last month, Glenmark Pharmaceuticals started Phase III trials of anti-flu drug Favipiravir as a potential treatment for patients suffering from Covid-19 in the country.
In addition, Strides Pharma Science obtained approval from the Drug Controller General of India (DCGI) to trial Favipiravir for Covid-19.
Last week, Sun Pharmaceutical Industries launched a Phase II trial of plant-derived (phytopharmaceutical) drug AQCH to treat the disease. This follows DCGI approval for the company to evaluate pancreatitis drug Nafamostat Mesilate to treat Covid-19.