Permission granted to conduct phase III clinical study of Ulinastatin for mild to moderate ARDS patients with COVID 19

An increasing number of global research teams believe Ulinastatin can potentially prevent the cytokine storm, causing death in COVID-19 patients

Bharat Serums and Vaccines Limited, Clinical study, DCGI, Ulinastatin, Acute Respiratory Distress Syndrome, COVID-19, Sanjiv Navangul

Bharat Serums and Vaccines Limited (BSVL), a leading biopharmaceutical company with presence in India and emerging markets, has announced that it has received approval from the regulatory agency DCGI to conduct phase III clinical study on Ulinastatin for mild to moderate Acute Respiratory Distress Syndrome (ARDS) patients with COVID 19. Clinical trial is expected to start at hospitals shortly.

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.

According to Sanjiv Navangul, Managing Director and CEO, BSVL, “Identifying effective antiviral agents and therapies to combat underlying pathology of COVID-19 is the need of the hour. As one of the leading biopharmaceutical companies in India, BSVL has a legacy of using scientific resources to treat patients in critical care, and we are channeling our efforts towards the ongoing fight against the COVID-19 pandemic. We began our innovation journey three decades ago and we are committed to continuing our efforts in developing and marketing innovative products to transform patient lives.”

While there is no approved treatment against the SARS-CoV-2 virus yet and experimental drugs are presently being used as a supportive therapy, Dr Swashraya Shah, Chief Medical Officer shares heartening data points, “Meta-analysis of 2300+ ARDS patients treated with Ulinastatin has shown significant improvement along with four parameters. Those parameters typically are an improvement in oxygenation index (PaO2/FiO2), shorteninduration of mechanical ventilation, and reduced mortality & ICU stay as compared to conventional therapies.”

Intensivists currently use Ulinastatin in India for severe sepsis and other critical clinical condition (acute pancreatitis). “This drug is a serine protease inhibitor.  It exhibits anti-inflammatory activity by suppressing the infiltration of neutrophils and release of elastase and other chemical mediators of inflammation [tumour necrosis factor (TNF)-α, and interleukin (IL)-1, 6 & 8] from them. Patients with severe COVID-19 infection can develop fatal lung damage from a cytokine storm due to increase in pro-inflammatory cytokines. Ulinastatin could combat underlying inflammatory condition in COVID-19 patients experiencing mild to moderate ARDS,” Dr Shah explains.

As per the approved clinical trial protocol, subjects with mild to moderate COVID-19 will be randomized in the study in a 1:1 ratio with Ulinastatin and standard supportive care or standalone standard supportive care. Ulinastatin is currently manufactured at BSVL Ambernath facility in Thane, Maharashtra, India.