• Ulinastatin, a serine protease inhibitor forays to phase III clinical trials; an add on therapy for patients infected by COVID 19 with mild and moderate ARDS

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

MUMBAI, INDIA, JUNE 09, 2020 (GPN): Bharat Serums and Vaccines Limited (BSVL), a leading biopharmaceutical company with presence in India and emerging markets, today 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 3 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), shortening duration 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. ENDS

About Bharat Serums and Vaccines Limited (BSVL)

Bharat Serums and Vaccines Limited (BSVL), founded in 1971, has been a pioneer in the development of blood components and therapeutic antibody products for infectious and non-infectious diseases. Over the years, BSVL has focussed on utilizing its scientific resources to develop several biological, biotechnology and pharmaceutical products to treat various types of diseases, contributing to preserve, protect and enhance the quality of life.

BSVL’s Research & Development credentials

• Biological
  • High Pure HMG                     First Indian Company to develop & market in India
  • Urinary Trypsin Inhibitor       First to develop & market in India
  • Equine Rabies Ig                    First to develop & market in India
  • Anti Thymocyte Globulin       First to develop & market in India
• Biotech
  • Recombinant FSH First Biogeneric in India
  • Monoclonal Anti D First in world to market 
  • Monoclonal Tetanus World’s first monoclonal product
  • Recombinant HCG First Biogeneric in India
• Drug Delivery
  • Propofol Emulsion First to develop & market in India
  • Amphotericin Emulsion World ‘s first Emulsion formulation
  • Goserelin Implant First Generic in India
  • Leuprolide Depot Second Generic in India
  • Liposomal Amphotericin First Generic in India. ENDS