RedHill Biopharma Ltd. announced that the first patient has been enrolled in the Austere environments Consortium for Enhanced Sepsis Outcomes' (ACESO) U.S. government-supported PROTECT multinational platform trial for early COVID-19 outpatient treatment. RHB-107 (upamostat) is the first drug being tested in this platform study. Funded through non-dilutive external sources, including the U.S. Department of Defense, the PROTECT study is expected to be conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by the end of 2024.

Data from RHB-107's previous U.S. Phase 2 study showed a 100% reduction in hospitalization due to COVID-19, with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized for COVID-19 on the placebo-controlled arm (nominal p-value=0.0317). The study also showed an approximately 88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with 2.4% of the RHB-107 treated group (1/41) versus 20% (4/20) of patients in the placebo-controlled arm (nominal p-value=0.036) reporting new severe COVID-19 symptoms. Further post-hoc analysis showed faster recovery periods from severe COVID-19 symptoms with a median of 3 days to recovery with upamostat compared to 8 days with the placebo. The ACESO PROTECT study is an adaptive, randomized, double blind, multi-site Phase 2 platform trial, being conducted by researchers from ACESO and partner organizations, and administered by the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF).

The study will compare investigational products (IPs) to control, in standard-risk, non-hospitalized adult SARS-CoV-2 infected participants with at least two moderate-severe symptoms at baseline. RHB-107 is the initial drug being evaluated in the early treatment arm of the study. The primary efficacy assessment in the early treatment indication will be time to sustained alleviation or resolution of COVID-19 symptoms. Participants will be followed for a period of up to 12 weeks.

Selection of IPs for inclusion in the ACESO PROTECT study is based on review of the preclinical and early clinical data, evaluating safety, tolerability, and efficacy. Selection is also based on route of administration and product availability. RHB-107's development for COVID-19 runs parallel to the development of opaganib, RedHill's other novel oral drug, for Acute Radiation Syndrome, being done in collaboration with, and funded by, the U.S. government's National Institutes of Health Radiation and Nuclear Countermeasures Program.

Both RHB-107 and opaganib also recently demonstrated distinct synergistic effect when combined individually with remdesivir, significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.