A Triangle drugmaker testing its Covid-19 treatment around the globe is hoping to add Russia to the list with its newest application to begin clinical trials.
On Wednesday, Raleigh’s RedHill Biopharma (Nasdaq: RDHL) announced it has submitted a clinical trial application with the Russian Ministry of Health. If approved, the Phase 2/3 clinical study would evaluate the company’s drug, opaganib, on hospitalized patients with severe Covid-19 infections and pneumonia.
The study would enroll about 270 Russian patients, with its endpoint being the proportion of patients requiring intubation and mechanical ventilation by day 14. The company says an interim analysis will be done when 100 of the patients have met the endpoint, meaning some results could be expected before the end of the trial.
“We are moving rapidly to advance our development program with opaganib for Covid-19,” said Dr. Mark Levitt, the company’s medical director. “We are expanding the development program to Russia and additional countries, in parallel with the U.S. clinical study, in order to accelerate the collection of robust data on the potential efficacy of opaganib against Covid-19.”
In addition to the Russia study, the company is also working to complete enrollment for its Phase 2a study of opaganib in the U.S., which it announced last month.
Opaganib, which is taken orally, was previously given special approval from both the Israeli and Italian governments, and has produced preliminary evidence that it is improving outcomes for moderate to severe patients with coronavirus. All of the six patients in the company’s Israel trial were “weaned from oxygen and discharged from the hospital,” the company said. RedHill is headquartered in Israel with its U.S. operations based in Raleigh.
RedHill has also tested its treatment on patients in Italy.
In total, the company now reports 141 subjects have been dosed with opaganib to date in ongoing and completed Phase 1 and 2 clinical studies. It hopes to continue adding more patients to that list.
“We are working closely with government agencies worldwide to allow more patients access to opaganib through clinical studies and compassionate use programs, and are also evaluating governmental funding opportunities for our Covid-19 development programs to address the urgent need for effective therapies,” said Gilead Raday, the company’s chief operating officer.
RedHill has been working throughout the pandemic to deploy its intellectual assets to address the virus. In addition to its trials of opaganib, the company also entered into an agreement with the National Institute of Allergy and Infectious Diseases in April to test another drug against lung damage caused by the virus.
The drug, RHB-107, is thought to be able to inhibit viral attachment and replication, as well as decreasing lung damage from viral pneumonia. The drug has been in 10 clinical studies already and was selected for in-vitro testing by the NIAID following an evaluation of its data.
This year, RedHill has been focused on the commercial launch of its newly approved asset, Talicia.
With the global pandemic pushing regulators and medical providers to find effective therapeutics in the battle against Covid-19, RedHill has said it is “preparing for a potential ramp-up of manufacturing of opaganib” if continued success with treatment leads to a spike in demand.
Original Article Source: Triangle Business Journal