Opaganib, an investigational drug, is a proprietary oral small molecule sphingosine
kinase-2 (SPHK2) selective inhibitor with potential for broad activity across oncology,
infectious diseases and metabolic disorders, with additional evaluation ongoing for opaganib as
a radioprotectant.
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Opaganib is undergoing a Phase 2 study in combination with Bayer’s darolutamide in men with
metastatic castration-resistant prostate cancer (mCRPC) and has completed a prior
investigator-sponsored Phase 2 study evaluating its safety and efficacy in
progressive mCRPC treated with androgen-signaling blockers, abiraterone or
enzalutamide.
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Opaganib completed a single-arm Phase 2a clinical study in patients with advanced, unresectable
cholangiocarcinoma and has been granted FDA Orphan Drug Designation for this indication.
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Acute respiratory distress syndrome (ARDS), including COVID-19
and influenza
Phase 2/3 COVID-19 (ARDS)
Opaganib is being evaluated for its potential to treat acute respiratory distress syndrome (ARDS)
caused by viruses such as COVID-19 and influenza. Data from the global Phase 2/3 study in
hospitalized patients with severe COVID-19 pneumonia offer a compelling rationale for further
investigation into opaganib’s potential in treating virus-induced ARDS, potentially supporting a
Phase 2/3 study in this indication.
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Gastrointestinal acute radiation syndrome
Opaganib is being evaluated as a potential new therapeutic approach to treat gastrointestinal
acute radiation syndrome (GI-ARS), with development intended to follow the FDA Animal Rule.
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RHB-204 is an investigational, proprietary, fixed-dose, orally administered, antibiotic
combination therapy targeting Crohn’s disease in Mycobacterium avium subspecies
paratuberculosis-positive (MAP+) patients. It is a next-generation formulation of
RedHill’s RHB-104, which demonstrated positive results in a Phase 3 Crohn’s disease
study, meeting both primary and secondary endpoints. RHB-204 combines the same
antimicrobial agents as RHB-104 with potent intracellular, anti-mycobacterial, and
anti-inflammatory properties, but with an optimized dosing profile designed to support
enhanced tolerability, safety and adherence.
RHB-204 also has potential for the treatment of pulmonary nontuberculous mycobacterial (NTM)
disease caused by Mycobacterium avium complex (MAC).
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An innovative Phase 2 study of RHB-204 is planned in patients with moderate to severe Crohn’s
disease who test positive for Mycobacterium avium subspecies paratuberculosis (MAP).
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A previously ongoing U.S. Phase 3 study evaluating RHB-204 for the treatment of pulmonary
nontuberculous mycobacterial (NTM) disease caused by Mycobacterium avium complex (MAC)
was terminated due to a low patient accrual rate.
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RHB-107 (INN: upamostat) is a first-in-class, once-daily, orally administered serine protease
inhibitor targeting multiple potential indications, including viral infections such as COVID-19
and influenza, oncology and inflammatory gastrointestinal diseases.
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RHB-107 completed a positive U.S. Phase 2 study in non-hospitalized symptomatic COVID-19
patients, which evaluated the safety and tolerability profile of RHB-107, along with efficacy
signals.
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RHB-102 is a proprietary bimodal immediate and extended-release, once-daily, oral tablet
formulation of the antiemetic drug ondansetron, a 5-HT3 antagonist, targeting
GLP-1/GIP-associated GI intolerance, acute gastroenteritis and gastritis, IBS-D and oncology
support.
RHB-102 is being developed by our partner Hyloris Pharmaceuticals outside of North America. Learn
more.
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GLP-1/GIP-associated GI Intolerance
Planned Phase 2 proof-of-concept study
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Gastroenteritis and gastritis
Completed positive U.S. Phase 3 study
RHB-102 (24 mg) successfully completed a randomized, double-blind, placebo-controlled U. S.
Phase 3 study meeting the primary outcome measure, demonstrating its safety and efficacy in
the treatment of acute gastroenteritis and gastritis.
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IBS-D
Completed positive U.S. Phase 2 study
RHB-102 (12 mg) successfully completed a positive randomized, double-blind, placebo controlled
U.S. Phase 2 study meeting the primary outcome measure, demonstrating its safety and efficacy in
the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
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RHB-102 (24 mg) is in development for the management of chemotherapy and radiotherapy induced
nausea and vomiting (also referred to as CINV and RINV) in the UK by our partner, Hyloris
Pharmaceuticals.
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