Israeli biopharmaceutical company RedHill Biopharma has announced that it has accelerated its COVID-19 programme with the submission of new clinical trial applications in Mexico and Brazil.
The applications, one to the Mexican Federal Committee for the Protection against Sanitary Risks (COFEPRIS) and the Brazilian Health Regulatory Agency (ANVISA), are for the phase 2/3 clinical study evaluating opaganib in patients hospitalised with severe COVID-19 and pneumonia.
Opaganib is a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer, anti-inflammatory and anti-viral activities. By inhibiting SK2, opaganib could impact multiple cellular pathways which are associated with cancer growth, viral replication and pathological inflammation.
RedHill has already had applications for this study approved in the UK and Russia, with a similar application currently under review in Italy. The company also hopes to expand the study into additional countries over the coming months.
The study will be multi-centre, randomised, double-blind and placebo-controlled, and is set to enrol up to 270 patients with severe COVID-19 pneumonia requiring hospitalisation and treatment with supplemental oxygen. Participants will be randomised to receive either opaganib treatment or placebo, alongside standard-of-care therapy.
The trial’s primary endpoint is to evaluate the proportion of patients requiring intubation and mechanical ventilation by day 14. An interim analysis is planned to be conducted by an independent data safety monitoring board when around 100 participants have been evaluated for the primary endpoint.
Last month, RedHill announced results from the first patients with severe COVID-19 to be treated with opaganib. Analysis of five patients treated with opaganib under compassionate use showed substantial benefits in both clinical outcomes and inflammatory markers compared to a retrospective matched case-control group from the same hospital.
All patients in the opaganib-treatment group were discharged from hospital without requiring mechanical ventilation compared to 33% of the matched case-control group. The median time of weaning patients off high-flow nasal cannula was reduced to ten days for the opaganib-treatment group compared to 15 days in the matched case-control group.
“We are advancing rapidly with our phase 2/3 program for COVID-19 and continue to expand the study to additional countries where there is substantial growth in diagnosed cases. With the study now approved in the UK and Russia, and additional approvals expected in the coming weeks, patient enrolment is planned to commence later this month,” said Aida Bibliowicz, vice president of clinical affairs at RedHill.
“In parallel, good progress has been made with the ongoing phase 2 study with opaganib in the US. If successful, our goal is for the compiled clinical data set to support potential applications for emergency use authorisation in the fourth quarter of this year,” she added.