RedHill Biopharma announced today it has begun its phase 2 clinical trial by enrolling its first participant in a smaller outpatient study.
“Enrollment of the first patient in the study marks an important milestone for RHB-107 in the 300-patient U.S. government-supported PROTECT platform study, which could add significant validating data to the previous marked reduction in hospitalizations due to COVID-19 seen in the RHB-107 arm of our earlier U.S. Phase 2 study,” RedHill’s Chief Operating Officer and Head of R&D Gilead Raday said.
According to the company, results from a previous 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 RHB-107 compared to 8 days with the placebo.
[Read More: Dual Anti-Viral/Anti-Inflammatory Drug Study Against COVID-19 Begins]
Trial Parameters and Endpoints
This trial is looking to include 300 participants and is is expected to be conducted in the United States, Thailand, Ivory Coast, South Africa, and Uganda. The study will compare investigational therapies to control, in standard-risk, non-hospitalized adult SARS-CoV-2 infected participants with at least 2 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.
What You Need to Know
The initiation of phase 2 clinical trials for RHB-107 (upamostat) by RedHill Biopharma will mark a step toward evaluating its effectiveness as an outpatient treatment for COVID-19.
The phase 2 trial is set to enroll 300 participants across multiple countries, including the United States, Thailand, Ivory Coast, South Africa, and Uganda.
RHB-107 stands out as a first-in-class, orally administered investigational antiviral. Its mechanism of action, targeting human serine proteases involved in viral entry, suggests potential efficacy against various strains of the virus, including emerging variants with mutations in the spike protein.
This study is part of the Austere environments Consortium for Enhanced Sepsis Outcomes’ (ACESO) US government-supported PROTECT multinational platform trial for early COVID-19 outpatient treatment. RHB-107 is the first drug being tested in this platform study.
The Agent
RHB-107 is a proprietary, first-in-class, once-daily orally administered investigational antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein.
In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several phase 1 studies and 2 Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients.
Timetable
The company estimates the trial to be completed by the end of the year. With limited antiviral options currently available, they see a clinical need for COVID-19 treatment in outpatient care settings. “If approved, RHB-107 could provide a much-needed additional option for use in the early COVID-19 treatment space, alongside Paxlovid,” Raday added.
Reference
RedHill Announces First Patient Enrolled in U.S. Government-Supported COVID-19 Study. news release. April 24, 2024. Accessed April 24, 2024.
https://www.redhillbio.com/news/news-details/2024/RedHill-Announces-First-Patient-Enrolled-in-U.S.-Government-Supported-COVID-19-Study/default.aspx
