Mumbai-based Navin Saxena Research & Technology (NSRT) plans to start Phase II clinical trial of Eflornithine granules 2.5 gm for the treatment of moderate COVID-19 infection by the first week of January 2021. The company aims to complete the study by March 2021.
On December 9, 2020, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) granted permission to the company to initiate the BREATHEAZY TRIAL 1.1 – A, a Phase II trial of Eflornithine (NSRT2020) carried in adult hospitalised patients with moderate COVID-19 infection.
The SEC’s recommendations come with conditions that the 7-point WHO ordinal scale should be used for the Phase II clinical trials and sample size should be increased to 208.
Earlier, the SEC had asked the company to revise the design of Clinical Trial to conduct a superiority trial of the Eflornithine granules 2.5gm and 5.0gm against Surveillance on Consumer (SoC) in moderate COVID-19.
Later the SEC asked the company to focus on moderate COVID 19 patients and hence the firm decided that lower strength 2.5gms would be more appropriate and has taken off the higher dose strength from the trial.
Following the latest recommendations given by the SEC, NSRT has now planned to conduct a randomised, multi-centre trial in 208 volunteers in four cities namely; Delhi, Lucknow, Pune and Bangalore.
Dr Kunal Saxena, MD, Rusan Pharma, said, “We plan to start the BREATHEAZY TRIAL 1.1 by the first week of January 2021 and targeting to complete the study by March 2021. The initial proof concept studies have shown great promise and we are confident that the molecule, the dosage and the treatment regimen will prove to be as efficacious as we think.”
Earlier, the company conducted in-vitro studies at the National Institute of Virology (NIV) in Pune to test the activity of Eflornithine in reducing the viral load of the COVID-19. Subsequently, NSRT also developed a patented oral Eflornithine (NSRT2020) using the Active Pharmaceutical Ingredient (API) – Eflornithine Hydrochloride, manufactured by Rusan Pharma at its API manufacturing facility in Ankleshwar.