Opaganib is a proprietary first-in-class investigational, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor drug. Potentially broad-acting, it is in development for multiple oncology, viral, inflammatory, metabolic (diabetes and obesity) and additional indications.
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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 has 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, and was also included in the U.S. Government-supported Phase 2 platform trial for early COVID-19 outpatient treatment (the PROTECT study).
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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.
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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.
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