NSRT to conduct phase II trials of Eflornithine to treat COVID-19

The Navin Saxena Research & Technology (NSRT) plans to conduct phase II clinical trials to test Eflornithine against COVID-19. The trials will be conducted in four cities namely; Delhi, Lucknow, Pune, and Bengaluru. The company will begin trials shortly and aims to complete the study in three to four months.

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 developed a patented oral Eflornithine (NSRT2020) using the active pharmaceutical ingredient (API) – Eflornithine Hydrochloride, manufactured by Rusan Pharma at their API manufacturing facility in Ankleshwar.

Recently, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) asked the company to revise the design of the clinical trial to conduct a superiority trial of the Eflornithine granules 2.5 gm and 5.0 gm against Standard of Care (SoC) in moderate COVID-19 cases with the following conditions:

1. SoC should be defined as per Government of India guidelines and shall be uniform across all the trial sites.

2. SoC should be administered in all the treatment arms.

3. Patients between the ages of 18 to 65 years to be included in the study.

4. Severity criteria should be defined as per Government of India guidelines.

5. Eflorithine 10g/day in divided dose should be used in the test arm.

6. Management of treatment failure patients to be defined in the protocol

7. Change in two-point improvement in clinical efficacy as per WHO ordinal scale should be the primary endpoint.

8. Assessment of mortality rate in 28 days should be one of the secondary endpoints.

9. Proper justification for sample size should be provided.

Following the recommendations, the company will shortly present the protocol (BREATHEAZY TRIAL 1.1) which will test a single dose of oral Eflornithine (NSRT2020) in moderate COVID-19 patients

“The study will take about three to four months to complete. With the Indian Council of Medical Research (ICMR) now in the midst of removing plasma therapy, interferon-Beta, lopinavir, remdesivir and hydroxychloroquine from the clinical management guidelines due to lack of satisfactory evidence in treating COVID-19 patients, Eflornithine (NSRT2020) may offer a new ray of hope in managing COVID-19 patients,” informs Dr Kunal Saxena, MD, NSRT.

NSRT has completed pharmacokinetic (PK) studies of oral Eflornithine (NSRT2020) in healthy patients at Quantys Clinical.

“In a proof of concept pilot study conducted in moderate to severe hospitalised COVID19 patients, two doses of NSRT2020 in two treatment arms (Arm 1 & Arm 2) were compared against Standard of Care (SoC) (Arm 3) in which remdesivir was primarily administered. The percentage of patients that recovered (RT-PCR negative) was 83 per cent in Arm 1, 50 per cent in Arm 2 and 33 per cent in Arm 3. The mean time to overall clinical improvement assessed on an 8-point ordinal scale recommended by the WHO and the mean duration of hospitalisation was comparable between Eflornithine and the SoC arm,” informed Saxena.

Reportedly, a study conducted by the Pasteur Institute in France also showed that Eflornithine inhibits the levels of host polyamines, which in turn restricts the replication of RNA viruses such as Middle East respiratory syndrome coronavirus (MERS-CoV), Dengue, chikungunya virus, Zika virus, and Ebola.