RedHill Biopharma's (RDHL) Phase 2/3 COVID-19 Study of Opaganib Passes Fourth DSMB Review with Unanimous Recommendation to Continue
Get Alerts RDHL Hot Sheet
Join SI Premium – FREE
RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a fourth independent Data Safety Monitoring Board (DSMB) safety review. The DSMB's recommendation is based on an analysis of unblinded safety data from the first 255 patients treated for 14 days, extending the total opaganib safety database to approximately 380 patients.
Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill, said: "With approximately 380 patients in the opaganib safety database following this positive fourth DSMB review, we are building a clear picture of the safety profile of opaganib." Dr. Levitt continued: "Moreover, adding together the positive Phase 2 data, the successful DSMB futility reviews and the outcomes from compassionate use of opaganib, we look forward with optimism to the reporting of top-line data from the Phase 2/3 study, which will provide the clearest indication to date of opaganib's promise in treating COVID-19."
The global Phase 2/3 randomized, double-blind, parallel-arm, placebo-controlled study of opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen (NCT04467840), is over 75% enrolled in approximately 40 recruiting sites.
RedHill recently announced positive top-line safety and efficacy data from the non-powered U.S. Phase 2 study with opaganib in 40 patients with COVID-19 pneumonia, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14, on top of standard-of-care. The Phase 2 data also showed no material safety differences between the opaganib and placebo on top of standard-of-care treatment arms - further adding to the growing safety database for opaganib.
To find out more about RedHill Biopharma's Expanded Access policy, please visit: www.redhillbio.com/expandedaccess.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- RedHill Biopharma (RDHL) Announces First Patient Enrolled in U.S. Government-Supported COVID-19 Study
- AstraZeneca (AZN) Announces Voydeya Approval in EU as add-on to ravulizumab or eculizumab
- Ocean Biomedical (OCEA) Announces Receipt of Notice from Nasdaq Regarding Late Filing of Annual Report on Form 10-K
Create E-mail Alert Related Categories
Corporate News, FDARelated Entities
Twitter, Definitive Agreement, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!