Biopharma firm wraps enrollment for Phase II COVID-19 study

Specialty biopharmaceutical firm RedHill Biopharma has completed enrollment of its Phase II study using opaganib (Yeliva) in patients hospitalized with severe COVID-19 pneumonia. The company expects topline data to come out in the next few weeks.

Gilead Raday, chief operating officer and head of R&D at RedHill Biopharma, told Outsourcing-Pharma that companies like his must balance the need for quality and accuracy in their work, with pressure to develop viable treatments for the deadly virus as rapidly as possible.

“By creatively designing in the necessary rigor to provide clear understanding and direction at each step we are able to work in parallel and organically speed up the development process – whether it is for COVID-19 or any other disease​,” he explained. “An additional advantage is that we are a small, tight-knit and agile team that has a very clear focus on where, when and how we apply our resources​.”

Mark Levitt, RedHill medical director, said completing enrollment in the study of the orally administered drug means the firm is weeks away from greater understanding of the treatment’s potential.

“Opaganib has a demonstrated unique dual mode of action that is both anti-inflammatory and antiviral – acting on the cause and the effect of COVID-19​,” he said. “Moreover, opaganib acts on a host cell component involved in viral replication and not the virus itself, which could minimize issues of resistance due to emergence of viral mutations​.”

Levitt added the company also is working on a parallel Phase II/III study exploring the viability of opaganib in potential emergency use authorization  applications.

The Phase II study (randomized, double-blind, and placebo-controlled) has enrolled 40 patients at clinical sites across the US. Rather than being powered for statistical significance, the research is centered on safety evaluation and identifying a signal of efficacy. Patients in the study were randomized at a 1:1 ratio to receive either opaganib or placebo on top of standard-of-care.

According to the company, the study’s primary objective is evaluating reduction in total oxygen requirement over the course of treatment for up to 14 days. Secondary endpoints include time to 50% reduction in oxygen requirements, proportion of patients without fever at day 14, and proportion with negative nasal swabs at Day 14. 

The parallel global Phase II/III study, also involving use of opaganib in patients with severe COVID-19 pneumonia (NCT04467840) is approximately 50% enrolled; RedHill reportedly expects it to report topline data in the first quarter of 2021. The study is being conducted across 21 clinical sites and is on track to enroll up to 270 patients.

Opaganib, a new chemical entity, is a proprietary, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib reportedly also has shown has also shown anticancer activity, as well as the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications. 

The opaganib studies are among a number of projects RedHill is tackling involving potential COVID-19 treatments. Raday also told us the company recently received approval from the US Food and Drug Administration for an investigational new drug application for a Phase II/III study (expected to kick off early next year) evaluating orally administered upamostat in COVID-19 patients exhibiting symptoms but that do not require hospitalization.