RHB-107 (INN: upamostat), an investigational drug, is a first-in-class, once-daily, orally administered,
potent inhibitor of serine proteases targeting multiple indications, including viral
infections such as COVID-19, oncological and gastrointestinal diseases.
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 has completed a Phase 2 study in non-hospitalized symptomatic COVID-19 patients which evaluated the safety and tolerability profile of RHB-107 and 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 multinational platform trial for early COVID-19 outpatient treatment to be conducted in the U.S., Thailand, Ivory Coast and South Africa. The Company also announced that the 300-patient Phase 2 study, predominantly funded by the U.S. Government’s Joint Program Executive Office (JPEO) for Chemical, Biological, Radiological and Nuclear Defense, has received FDA clearance to start and is estimated to be completed by end of 2024.
RHB-107
is also being pursued in development programs against additional viral targets, including influenza and other viruses.
RHB-107
has previously undergone several Phase 1 studies and two Phase 2 proof-of-concept studies. 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.
RHB-107's
safety profile has been demonstrated in approximately 300 participants, including in Phase 2 studies in
oncology indications and COVID-19.
The completed Phase 2 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.