RedHill Biopharma Ltd. announced that RHB-107 (upamostat) has 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 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 and is estimated to be completed by end of 2024.

Expected to begin enrolling patients in the third quarter of 2023, 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 investigational products for inclusion in the study was based on review of the preclinical and early clinical data, evaluating, safety, tolerability, and efficacy of the IP. Selection is also based on route of administration and product availability.

Products with oral, subcutaneous, and intramuscular delivery modes have been prioritized due to acceptability and feasibility of administration. Data from RHB-107?s 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 approx.

88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with only 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 from severe COVID-19 symptoms with a median of 3 days to recovery with upamostat compared to 8 days with placebo. Discussions for external non-dilutive funding for RHB-107 Phase 3 COVID-19 development, in addition to the platform study, are advancing. Several collaborative projects for pandemic preparedness testing RHB-107, with government and non-government bodies, in a range of preclinical studies against other viral targets are ongoing and under discussion with government and non-government bodies.