Phase 2/3 COVID-19 study evaluates safety, potential identification of preliminary efficacy signals
Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021. Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate the safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib.
Opaganib potentially minimizes the likelihood of resistance due to viral mutations by targeting a human cell component involved in viral replication
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) in patients hospitalized with severe COVID-19 pneumonia has received a second unanimous recommendation to continue, following a second independent Data Safety Moni
Voyager Therapeutics Provides Update on NBIb-1817 (VY-AADC) Gene Therapy Program
CAMBRIDGE, Mass., Dec. 22, 2020 (GLOBE NEWSWIRE) Voyager Therapeutics, Inc. (Nasdaq: VYGR) today announced that the U.S. Food and Drug Administration (FDA) has notified Neurocrine Biosciences (Nasdaq: NBIX) that it has placed a clinical hold on the RESTORE-1 clinical trial of NBIb-1817 (VY-AADC). As previously announced, trial sites participating in RESTORE-1 had not been screening, enrolling or dosing patients as a result of the COVID-19 pandemic and more recently, as a result of the independent Data Safety Monitoring Board (DSMB)’s request to pause dosing pending its review of additional data. The DSMB has requested additional patient level data from the trial and now plans to review these data in early 2021. The clinical hold follows the submission by Neurocrine Biosciences of an IND Safety Report related to the observation of MRI abnormalities in some RESTORE-1 study participants. The clinical i
22 dicembre 2020
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 data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
Opaganib potentially minimizes likelihood of resistance due to viral mutations by targeting a human cell component involved in viral replication
RedHill s Phase 2/3 COVID-19 Study of Opaganib Passes Second DSMB with Unanimous Recommendation to Continue
Top-line data from the
global Phase 2/3 COVID-19 study expected Q1/2021
Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
Opaganib potentially minimizes likelihood of resistance due to viral mutations by targeting a human cell component involved in viral replication
TEL AVIV, Israel and RALEIGH, N.C., Dec. 22, 2020 /PRNewswire/ 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)
Credit: RedHill Biopharma
Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021
Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
Opaganib potentially minimizes likelihood of resistance due to viral mutations by targeting a human cell component involved in viral replication
TEL AVIV, Israel and RALEIGH, NC, December 22, 2020, 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) in patients hospitalized with severe COVID-19 pneumonia has received a second unanimous recommendation to continue, following a second independent Data Safety Monitoring Board (D