RHB-107 (INN: upamostat) (formerly MESUPRON) is a first-in-class, once-daily, orally-administered, potent inhibitor of serine proteases targeting multiple indications, including COVID-19, cancer, inflammatory lung diseases and gastrointestinal diseases.
RHB-107, an investigational drug, has undergone several Phase 1 studies and two Phase 2 studies, in locally advanced non-metastatic pancreatic cancer and in metastatic breast cancer, demonstrating its clinical safety and tolerability profile in approximately 200 patients. The Phase 2 studies with RHB-107 in both indications suggested activity as measured by both tumor response rate and overall survival of patients when administered in combination with first-line chemotherapeutic agents.
RHB-107 is being evaluated in a U.S. Phase 2/3 study for treatment in non-hospitalized patients with symptomatic COVID-19 who do not require supplemental oxygen (NCT04723527). RedHill recently announced positive results from Part A of the Phase 2/3 study in which the primary endpoint of favorable safety and tolerability was met, and demonstrating promising preliminary efficacy findings of RHB-107 in non-hospitalized COVID-19 patients.
RHB-107 was granted FDA Orphan Drug designation for the adjuvant treatment of pancreatic cancer.
The study with RHB-107 is 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.