Preliminary data from a noninvasive U.S. Phase 2 study of 40 hospitalized patients indicate that orally administered opaganib was safe, with no substance safety differences between opaganib and control arms.
Regular trends indicate further improvement in reducing oxygen requirement before the end of Day 14 treatment in the opaganib-treated arm over key primary and secondary efficacy outcomes, linked to improvement clinical as defined by the World Health Organization (WHO) prescription scale.
The opaganib-treated arm showed a greater improvement in reaching room air within 14 days (52.6% vs. 22.2%); greater improvement in reduction to 50% supplemental oxygen by Day 14 (89.5% vs. 66.7%); higher proportion of patients discharged before Day 14 (73.7% vs. 55.6%) and greater reduction in median total oxygen requirement (AUC) over 14 days (68.0% vs. 46.7%).
Top-line data from the global Phase 2/3 COVID-19 study were expected in 270 patients in the Q1 / 2021 hospital and an interim DSMB income study is expected in the coming weeks. Opaganib targets a human cell part involved in viral reproduction, which may reduce the likelihood of resistance due to viral mutations.
TEL AVIV, Israel and RALEIGH, NC, announced December 31, 2020, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialized biopharmaceutical company, today announced that preliminary preliminary data from its U.S. showed a phase 2 study with orally administered opaganib (Yeliva®, ABC294640 ) in hospitalized patients with COVID-19 pneumonia advanced safety and efficacy indicators.
The US Phase 2 randomized, placebo-controlled randomized placebo-controlled randomized trial (NCT04414618) enrolled 40 patients in need of oxygen support. The study was not empowered for statistical significance and aimed to assess safety and identify signs of onset of activity. Patients in the study were randomized at a 1: 1 ratio to receive either opaganib or placebo in addition to standard care (SoC) and were followed for up to 42 days from onset of treatment.
- High-end results from the study found that opaganib was safe, with no material safety differences between the opaganib and placebo treatment arms. Overall, fewer patients experienced severe adverse events (SAEs) in the opaganib treatment arm than in the placebo arm. In this small sample size, there were few events of intubation or mortality and these were balanced between the two arms.
- The opaganib-treated arm showed a steady trend of greater improvement in reducing oxygen requirement before the end of Day 14 treatment across key primary and secondary efficacy outcomes, linked to clinical improvement such as defined by the World Health Organization (WHO) prescription scale:
- Greater improvement in the proportion of patients who reach room air and no longer require oxygen support with Day 14 vs. the control arm (52.6% vs. 22.2%).
- Greater improvement in the proportion of patients with a 50% reduction in supplemental oxygenation by day 14 vs. the control arm (89.5% vs. 66.7%).
- Higher proportion of patients discharged by Day 14 vs. the control arm (73.7% vs. 55.6%).
- Greater reduction from baseline total moderate oxygen requirement (AUC) over 14 days vs. the control arm (68.0% vs. 46.7%).
A full analysis of the data, including biomarker viral and inflammatory analyzes, baseline risk factors and SoC reverse therapy stratifications, is expected in the coming weeks. The Company will provide the data for peer review when available.
“We are pleased with these positive results from our Phase 2 investigative study that confirms the safety of opaganib and shows promising signs of activity when treating patients with COVID-19 and in need of oxygen support. These preliminary results support our ongoing global Phase 2/3 study in real COVID-19, which is expected to be read out in Q1 / 201. We will work diligently to establish a data set to build strong support to support the infiltration of global emergency use applications. ” Mark L. Levitt, MD, Ph.D., Medical Director at RedHill said.
Opaganib has a unique dual action mode that is both anti-inflammatory and anti-viral – working both on the cause and effect of COVID-19. Opaganib targets sphingosine kinase-2, a human cell component involved in viral reproduction and not the virus itself. “
Gilead Raday, Chief Operating Officer, RedHill Biopharma
The emerging evidence of new SARS-CoV-2 strains emerging worldwide highlights the importance of this unique mechanism, which may reduce the risk of viral exposure to treatment. The trends in patient development shown by the preliminary baseline data support the Phase 2/3 follow-up study with opaganib, which will provide a deeper understanding of opaganib activity. “
The efficacy of opaganib in true COVID-19 uptake is further investigated in an ongoing global Phase 2/3 study and is expected to report on baseline data in the first quarter of 2021. This study (NCT04467840) is being performed over approximately 30 clinical sites in several countries and is on track to enroll up to 270 patients.
The study was conducted on two unrelated studies of safety data by an independent Data and Safety Audit Board (DSMB), with unanimous recommendations for continuing the study. An interim analysis of DSMB’s future will be carried out in the coming weeks, evaluating data from the first 135 subjects that have reached the key completion point.
The top-line results from the U.S. Phase 2 study on opaganib in hospitalized patients with primary COVID-19 pneumonia were presented to the Company by an independent third party following an initial independent study and are still subject to further review and analysis.
Such revision and analysis may lead to conclusions that are inconsistent with the findings published in this publication and may not be repeated in future studies.