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Yeliva (opaganib (ABC294640), a new chemical entity, is a proprietary, rst-in-class, orally-administered, investigational sphingosine kinase-2 (SK2) selective inhibitor, with suggested dual anti-inammatory and antiviral activity.
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 12, 2022
Details:
The partnership with Kukbo also includes a right of first offer for RedHill's late-stage clinical assets, opaganib, RHB-107 (upamostat) and Talicia®, for one or more of the territories of South Korea, Japan, Indonesia, Vietnam, Thailand and/or Malaysia.
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: Kukbo Co.
Deal Size: $7.1 million Upfront Cash: $1.5 million
Deal Type: Licensing Agreement March 15, 2022
Details:
Phase 2 part of Phase 2/3 study of RHB-107 (upamostat), orally-administered antiviral, that targets human serine proteases in symptomatic COVID-19 successfully met study's primary endpoint showing good safety, tolerability and highly promising efficacy results.
Lead Product(s): Upamostat
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-107
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 March 01, 2022
Details:
In a prespecified analysis of Phase 2/3 study patients with positive PCR at screening, Yeliva (opaganib) improved the median time to viral RNA clearance by at least 4 days also showed 62% reduction in mortality seen in a post-hoc analysis.
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 January 13, 2022
Details:
Under the terms of agreement, RedHill has agreed to grant Kukbo a right of first offer, for a period of six months, for a license of late-stage clinical assets, opaganib, RHB-107 (upamostat)1 and Talicia®, for one or more of the territories.
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: Kukbo Co. Ltd.
Deal Size: $10.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement November 08, 2021
Details:
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity that acts on the viral cause and inflammatory effect of COVID-19.
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 October 04, 2021
Details:
While preliminary top-line data of the study efficacy endpoints showed consistent trends in favor of the opaganib arm, the study endpoints did not achieve statistical significance.
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 14, 2021
Details:
Opaganib is a novel, host-targeted, dual antiviral and anti-inflammatory investigational pill in advanced clinical development for the treatment of severe COVID-19.
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 19, 2021
Details:
Opaganib is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study, which recently completed enrollment, and has demonstrated positive safety and efficacy signals in preliminary top-line data from the 40-patient U.S. Phase 2 study.
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 June 28, 2021
Details:
The global study of 475 patients in phase 2/3 of opaganib in severe COVID-19 has been approved in 10 countries and on June 6 completed the enrollment in up to 57 participating points.
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 June 21, 2021
