RHB-107 (INN: upamostat), an investigational drug, is a first-in-class, once-daily, orally administered, inhibitor of serine proteases targeting multiple potential indications, including viral infections such as COVID-19 & Ebola virus disease (EBOV), oncology and inflammatory gastrointestinal diseases.
Viral Infections:
RHB-107 is a potentially broad-acting, host-directed antiviral that targets host cell factors involved in preparing the spike protein for viral entry into target cells and has the potential to remain effective against emerging viral variants with spike protein mutations.
RHB-107 successfully completed a Phase 2 study in non-hospitalized symptomatic COVID-19 patients which evaluated the safety and tolerability profile of RHB-107, along with efficacy signals (NCT04723537). The study’s positive results have been published in the peer-reviewed International Journal of Infectious Diseases.
RHB-107 has also been accepted for inclusion in the Austere environments Consortium for Enhanced Sepsis Outcomes’ (ACESO) U.S. Government-supported PROTECT platform trial for early COVID-19 outpatient treatment (NCT05954286). RedHill announced that the 300-patient Phase 2 study, which received FDA clearance to start is to be conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda. The study is predominantly funded by the U.S. Government Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). More recently, RedHill announced new non-dilutive external funding, which now covers the entirety of the RHB-107 arm of the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment. The new funding amounts to approximately $4.8M directed toward the evaluation of RHB-107 in the study, in addition to the previously announced U.S. Government non-dilutive funding.
RHB-107 is also being pursued in development programs against additional viral targets, including EBOV in collaboration with the U.S. Army, as well as influenza and other viruses. RedHill announced results from its in vitro study investigating the effects of RHB-107 and opaganib combined individually with remdesivir in a U.S. Army-funded and conducted Ebola virus study.
RHB-107 has previously completed several Phase 1 studies and two Phase 2 proof of concept studies in cancer patients. The first Phase 2 study was in locally advanced, non-metastatic pancreatic cancer and the second study was in metastatic breast cancer in combination with first-line chemotherapeutic agents.
RHB-107 was granted FDA Orphan Drug Designation for the adjuvant treatment of pancreatic cancer.
The clinical studies with RHB-107 are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.