Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral and anticancer activity, targeting multiple potential indications, including gastrointestinal acute radiation syndrome (GI-ARS), viral infections such as COVID-19, Ebola virus disease and additional viruses as part of pandemic preparedness, several cancers and diabetes and obesity-related disorders.
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Gastrointestinal acute radiation syndrome
Opaganib is being evaluated as a potential 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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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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Opaganib is being evaluated as a potential treatment for Ebola virus disease in collaboration with the U.S. Army and BARDA. Supported by initial funding from the BARDA research and development contract, the collaboration seeks to advance opaganib’s development to combat infections and control Ebola virus disease outbreaks.
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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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Opaganib is undergoing a Phase 2 study in combination with Bayer’s darolutamide in advanced prostate cancer and has completed a prior investigator-sponsored Phase 2 study evaluating its safety and efficacy in progressive metastatic castration-resistant prostate cancer (mCRPC) treated with androgen-signaling blockers, abiraterone or enzalutamide.
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RHB-204 is an investigational, proprietary, fixed-dose, orally administered antibiotic combination therapy targeting moderate to severe Crohn’s disease in Mycobacterium avium subspecies paratuberculosis-positive (MAP+) patients. It is a next-generation formulation of RHB-104, which demonstrated positive results in a Phase 3 Crohn’s disease study, meeting both primary and secondary endpoints. Like RHB-104, RHB-204 combines the same anti-microbial agents with potent intracellular, anti-mycobacterial, and anti-inflammatory properties, using optimized oral dosing to potentially enhance patient safety, tolerability 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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RHB-204, a next-generation formulation of RHB-104, is targeting moderate to severe Crohn’s disease in Mycobacterium avium subspecies paratuberculosis-positive (MAP+) patients. Supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in Crohn’s disease, RHB-204 is expected to advance to a Phase 2 study in MAP+ Crohn’s disease patients.
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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 & Ebola virus disease, oncology and inflammatory gastrointestinal diseases.
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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.
RHB-107 has already 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-107 is being evaluated as a potential treatment for Ebola virus disease in collaboration with the U.S. Army.
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RHB-102 is a patent-protected, proprietary, once-daily, bimodal extended-release, oral tablet
formulation of the antiemetic drug ondansetron, a 5-HT3 antagonist, targeting potential
indications including oncology support, acute gastroenteritis and gastritis, and IBS-D at two
dose strengths, 12mg and 24mg.
RHB-102 is being developed by Hyloris Pharmaceuticals outside of North America. Learn more.
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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.
RHB-102 is being developed by Hyloris Pharmaceuticals outside of North America. Learn more.
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IBS-D
Completed positive U.S. Phase 2 study
RHB-102 (12 mg) successfully completed a positive randomized, double-blind, placebocontrolled 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).
RHB-102 is being developed by Hyloris Pharmaceuticals outside of North America. Learn more.
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Oncology Support
Comparative bioavailability studies
RHB-102 (24 mg) is in development for the management of chemotherapy and radiotherapyinduced nausea and vomiting (also referred to as CINV and RINV).
RHB-102 is being developed by Hyloris Pharmaceuticals outside of North America. Learn more.
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