RedHill Biopharma Announces First Patient Dosed in U.S. Phase 2/3 COVID-19 Outpatient Study with RHB-107
- The U.S. Phase 2/3 study with once-daily, orally-administered RHB-107 (upamostat) evaluates treatment of patients with symptomatic COVID-19 who do not require hospitalization - the vast majority of patients - RHB-107 is a novel serine protease inhibitor targeting human cell factors involved in...
RedHill Biopharma Announces Positive DSMB Futility Review for Phase 2/3 COVID-19 Study of Opaganib
TEL AVIV, Israel and RALEIGH, N.C., Jan. 29, 2021 /PRNewswire/ -- RedHill
Biopharma Ltd.
RedHill Biopharma Further Expands Opaganib Manufacturing Capacity for COVID-19 with Cosmo Pharmaceuticals
TEL AVIV, Israel and RALEIGH, N.C., Jan. 28, 2021 /PRNewswire/ -- RedHill
Biopharma Ltd.
RedHill Biopharma's RHB-204 Granted FDA Fast Track Designation for NTM Disease
TEL AVIV, Israel and RALEIGH, NC, Jan. 6, 2021 /PRNewswire/ -- RedHill
Biopharma Ltd.
RedHill Biopharma Announces Positive Top-Line Safety and Efficacy Data from Phase 2 COVID-19 Study of Opaganib
Preliminary data from the non-powered U.S. Phase 2 study of 40 hospitalized patients shows that orally-administered opaganib was safe, with no material safety differences between opaganib and control arms Consistent trends demonstrate greater improvement in reducing oxygen requirement by end of ...
RedHill's Phase 2/3 COVID-19 Study of Opaganib Passes Second DSMB with Unanimous Recommendation to Continue
Independent DSMB unanimously recommends continuation of the global Phase 2/3 study of orally-administered opaganib in severe COVID-19 based on review of unblinded safety data from 155 treated patients Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021 Top-line d...
RedHill's Phase 2/3 COVID-19 Candidate Opaganib Reduces ARDS-Related Blood Clotting in Preclinical Model
Acute respiratory distress syndrome (ARDS)-induced thrombosis (blood clotting) may occur in up to one-third of COVID-19 patients requiring ICU admission and is a contributing cause of mortality Opaganib demonstrated reduced thrombosis in a preclinical model of ARDS Opaganib has also been shown t...
RedHill Biopharma Expands U.S.-Based Manufacturing Capacity of Opaganib for COVID-19
RedHill adds two more manufacturing partners, both U.S.-based, for large-scale manufacturing of opaganib, in preparation for potential emergency use applications as early as Q1/2021 The new collaborations follow recently announced collaborations with European and Canadian manufacturers U.S. Pha...
RedHill Biopharma to Present at Evercore ISI HealthCONx and Piper Sandler Healthcare Conferences
TEL AVIV, Israel and RALEIGH, N.C., Nov. 25, 2020 /PRNewswire/ -- RedHill
Biopharma Ltd.
RedHill Biopharma Initiates Phase 3 Study of RHB-204 for First-Line Treatment of NTM Disease
RHB-204 is being evaluated as a first-line, stand-alone, oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease - a rare condition with no FDA-approved first-line therapy The Phase 3 study is expected to recruit up to 125 patients across approximately 40 U.S. clinical sites RHB-...
RedHill Biopharma's Second COVID-19 Candidate, RHB-107, Cleared by FDA for Phase 2/3 Study in Symptomatic COVID-19 Disease
FDA clears IND application for Phase 2/3 study with RedHill's second novel COVID-19 candidate, RHB-107 (upamostat), an orally administered novel serine protease inhibitor, with demonstrated antiviral and potential tissue-protective effects The Phase 2/3 study is designed to evaluate outpatient-b...
RedHill Announces Unanimous DSMB Recommendation to Continue Phase 2/3 COVID-19 Study with Opaganib
Pre-scheduled independent Data and Safety Monitoring Board (DSMB) unanimously recommends continuation of the global Phase 2/3 study of orally administered opaganib in severe COVID-19 pneumonia Enrollment in the 270-patient global Phase 2/3 COVID-19 study with opaganib is more than 50% complete ...
RedHill Biopharma Completes Enrollment for COVID-19 U.S. Phase 2 Study with Opaganib - Data Expected in the Coming Weeks
Enrollment completed in the U.S. Phase 2 study evaluating opaganib's safety and initial efficacy signal in 40 hospitalized patients with severe COVID-19 pneumonia A parallel global Phase 2/3 study with orally administered opaganib for severe COVID-19 is approximately 50% enrolled - on track to e...
