Opaganib is a first-in-class new chemical entity with anti-inflammatory, anti-cancer and
antiviral activity, under development for multiple indications. Opaganib is an orally administered,
selective inhibitor of sphingosine kinase-2 (SPHK2), a lipid kinase with
multiple cellular functions - potentially inhibiting tumor growth, pathological
inflammation, and viral replication.
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Opaganib is being evaluated as a new therapeutic approach to mitigate gastrointestinal acute radiation syndrome (GI-ARS) in collaboration with the NIAID RNCP following the FDA Animal Rule regulatory pathway.
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Opaganib’s unique mechanism of action combines potent antiviral and anti-inflammatory activities.
Opaganib is host-targeted and is expected to remain effective against emerging viral variants.
Opaganib was studied in a global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840),
achieving efficacy trends in key patient sub-groups despite not meeting the primary endpoint and previously delivered U.S.
Phase 2 data in patients with moderate to severe COVID-19. RedHill is in ongoing discussions with multiple regulatory agencies
regarding potential pathways to approval.
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Opaganib has undergone a single-arm Phase 2a clinical study in patients with advanced, unresectable
cholangiocarcinoma – an orphan indication with strong unmet medical need.
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Opaganib has undergone an investigator-sponsored Phase 2 study evaluating its safety and
efficacy in metastatic castration-resistant prostate cancer (mCRPC) that was progressing
during treatment with androgen-signaling blockers abiraterone or enzalutamide.
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RHB-107 (INN: upamostat) is a first-in-class, once-daily, orally-administered serine protease
inhibitor targeting multiple indications, including viral infections such as COVID-19,
oncology and gastrointestinal indications.
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RHB-107 has been accepted for inclusion in the U.S. Government supported ACESO PROTECT study, an adaptive, randomized, double blind, multi-site Phase 2
platform trial for early COVID-19 outpatients which has received FDA clearance to start (expected Q3/23).
RHB-107 has already completed a U.S. Phase 2 study in non-hospitalized symptomatic COVID-19 patients which evaluated the safety and tolerability profile of
RHB-107 and efficacy signals.
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RHB-102 is a once-daily 24-hr bimodal release, oral tablet formulation of the antiemetic drug
ondansetron, a 5-HT3 antagonist in development for oncology support and other
gastrointestinal indications.
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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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Gastroenteritis and gastritis
Completed positive US 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 US 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-204 is a Phase 3-stage fixed-dose oral capsule with potential as a first-line,
stand-alone treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by
Mycobacterium avium Complex (MAC).
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A Phase 3 study was recently terminated due to low a low accrual rate.
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RHB-104 is an orally-administered, all-in-one combination antibiotic therapy, with
intracellular, antimycobacterial and anti-inflammatory properties, in development for Crohn’s disease.
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Crohn's disease
Completed positive Phase 3 study
RHB-104 has completed a positive first Phase 3 study in Crohn’s disease, meeting its primary and key secondary endpoints. It has also
completed a positive Phase 2a proof-of-concept study in relapsing remitting multiple sclerosis.
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