US Government supported Platform Trial, RHB-107.8 Aug 2023 10:22
The timescale involved is similar to the expected timescale for Synairgen’s parallel P2 trials. The antiviral treatment is targeted to treat the early onset of CV-19.
“RHB-107 accepted for inclusion in ACESO's PROTECT adaptive platform trial for early COVID-19 outpatient treatment to be conducted in the U.S., Thailand, Ivory Coast and South Africa
The substantial 300-patient Phase 2 study, predominantly funded by the U.S. Government Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), has received FDA clearance to start (expected Q3/23) and is estimated to be completed by end of 2024
If approved, RHB-107, a novel, oral, once-daily, broad-acting, host-directed antiviral is expected to act independently of viral spike protein mutations1, would potentially target a multi-billion-dollar early COVID-19 treatment market
RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including marked reduction in hospitalization due to COVID-19 in a U.S. Phase 2 study2”