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Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2020
Details:
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.
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Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: ABC294640
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2020
Details:
Opaganib, a novel, orally administered sphingosine kinase 2 (SK2) selective inhibitor, administered at 250mg/kg, showed a reduction of thrombosis (blood clotting) in an acute respiratory distress syndrome – a preclinical animal model designed to measure thrombotic risks.
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Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
The global Phase 2/3 study with opaganib (Yeliva®, ABC294640) in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a pre-scheduled safety review by an independent Data and Safety Monitoring Board.
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Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Details:
U.S. Phase 2 study with opaganib (Yeliva®, ABC294640) in patients hospitalized with severe COVID-19 pneumonia has completed enrollment of the last patient in the study.
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Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 13, 2020
Details:
Collaborations with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing further strengthens manufacturing capabilities and capacity, in preparation for potential emergency use applications.
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Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 13, 2020
Details:
Collaborations with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing further strengthens manufacturing capabilities and capacity, in preparation for potential emergency use applications .
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Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2020
Details:
The ongoing global Phase 2/3 study with orally-administered opaganib in patients with severe COVID-19 is approved in Italy, the UK, Russia, Israel, Mexico and Brazil; 16 clinical sites initiated globally to date.
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Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
Opaganib completely inhibited SARS-CoV-2 viral replication as measured after three days incubation in an in vitro model of human bronchial tissue, comparing favorably with remdesivir, the positive control in the study.
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Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
The 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.
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Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 30, 2020
Details:
RedHill Biopharma has initiated a global Phase 2/3 clinical study evaluating opaganib (Yeliva®) in patients hospitalized with severe SARS-CoV-2 infection (the cause of COVID-19) and pneumonia requiring treatment with supplemental oxygen.
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