Candidate: RHB-107 (upamostat, WX-671), alone and in combination with Opaganib (Yeliva®, ABC294640)
Type: RHB-107 is a first-in-class, orally-administered inhibitor of serine proteases that targets human cell factors involved in preparing the spike protein for viral entry into target cells. It is therefore expected to be effective against emerging viral variants with mutations in the spike protein, according to RedHill, which has said RHB-107 has potential for use in multiple oncology, gastrointestinal and inflammatory indications. RHB-107 is designed to combine combined antiviral and potential tissue-protective action.
2021 Status: RedHill Biopharma said February 17 that the first patient was dosed in its U.S. Phase II/III trial (NCT04723527) of RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care. The Phase II/III study is aimed at evaluating treatment with RHB-107 in patients with symptomatic COVID-19 early in the course of the disease, with a simple once-daily oral treatment in an outpatient setting.
The study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The first part of the study is designed for dose selection and is planned to enroll 60 patients. The second part of the study is planned to enroll 250 patients and will evaluate time to sustained recovery from illness as the primary endpoint. Each patient will be tested for specific viral strain.
RedHill said the Phase II/III trial is unique within a COVID-19 trial setting in making extensive use of telemetry and electronic patient-reported outcome (ePRO) data collection, based on the latest FDA guidance for symptom monitoring. Following patients’ initial visit to a medical facility, a research-trained nurse will make periodic home visits to study patients to collect samples for safety and virology monitoring
2020 Status: RedHill Biopharma said November 17 that the FDA has cleared the Company’s IND application for a Phase II/III trial evaluating RHB-107 in patients with symptomatic COVID-19 who do not require hospitalization.
The randomized, parallel-group double-blind study is expected to start enrolling patients early in 2021. The study will enroll patients with symptomatic diagnostically confirmed COVID-19 who do not require inpatient care. RHB-107 will be administered once daily for 14 days, with patients receiving follow-up for eight weeks from first dosing. The study’s primary endpoints will be time to recovery from symptomatic illness compared to placebo, as well as safety and tolerability of RHB-107. Several secondary and exploratory endpoints will also be assessed.
RHB-107 has shown strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial cell model, while its safety profile has been demonstrated in approximately 200 people, including in Phase II studies in oncology indications, RedHill said.
RedHill has licensed RHB-107 (formerly Mesupron®) from Heidelberg Pharma.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: