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InscriptionClinical Trial Application approved in Russia for the Phase 2/3 study with opaganib in severe COVID-19 patients following recent approval in the UK and similar submission in Italy
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The Phase 2/3 study aims to enroll 270 subjects in up to 40 clinical sites; enrollment planned to be initiated later this month with potential submission of Emergency Use Authorization application planned for Q4/2020
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In parallel, the U.S. Phase 2a study with opaganib in patients with severe COVID-19 is advancing rapidly with more than 25% of patients enrolled
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Approval also received for a clinical study with opaganib in Israel in up to 50 patients with severe COVID-19
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Treatment of patients with severe COVID-19 under compassionate use showed substantial benefit to such patients compared to a matched case-control group
TEL-AVIV, Israel and RALEIGH, N.C., July 16, 2020 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced approval from the Ministry of Health of the Russian Federation for its Clinical Trial Authorization (CTA) application for a Phase 2/3 study evaluating opaganib (Yeliva®, ABC294640)1 in patients hospitalized with severe SARS-CoV-2 infection (the cause of COVID-19) and pneumonia. The study was also recently approved in the UK and a similar application is under review in Italy with plans to further expand the study to additional countries.
“We are rapidly advancing the clinical development program with opaganib for COVID-19 and, if successful, plan to submit an application for Emergency Use Authorization in the fourth quarter this year. The Phase 2/3 study with opaganib in patients with severe COVID-19 has already received regulatory approvals in two countries and we are expanding the study to additional countries,” said Gilead Raday, RedHill’s Chief Operating Officer. “With planned initiation of the Phase 2/3 study later this month and with over 25% enrollment in the U.S. Phase 2a study, RedHill is well-positioned at the forefront of the race to bring novel potential beneficial therapies to hospitalized COVID-19 patients.”
The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study is set to enroll up to 270 patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects will be randomized at a 1:1 ratio to receive either opaganib or placebo, along with standard-of-care therapy. The primary endpoint of the study is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14. An unblinded futility only interim analysis will be conducted by an independent data safety monitoring board (DSMB) when approximately 100 subjects have been evaluated for the primary endpoint.
The Company further announced that it has received approval from the Israeli Ministry of Health to initiate a study evaluating opaganib in up to 50 patients with severe COVID-19 infection and pneumonia.
Enrollment is also ongoing for a randomized, double-blind, placebo-controlled Phase 2a clinical study with opaganib in the U.S. (NCT04414618). This study is set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen. This clinical trial is not powered for statistical significance.
RedHill recently announced that results from the treatment with opaganib of the first patients with severe COVID-19 have been published2. Analysis of treatment outcomes in five patients with severe COVID-19 showed substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital without requiring mechanical ventilation, whereas 33% of the matched case-control group required mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.
1 Opaganib is an investigational new drug, not available for commercial distribution.
2 The article was authored by Ramzi Kurd, MD, Shaare-Zedek Medical Center; Eli Ben-Chetrit, MD, Shaare-Zedek Medical Center and Hebrew University Faculty of Medicine; Hani Karameh MD, Shaare-Zedek Medical Center and Maskit Bar-Meir, MD, Shaare-Zedek Medical Center and Hebrew University Faculty of Medicine. See full text here: https://www.medrxiv.org/content/10.1101/2020.06.20.20099010v1?rss=1.
