RedHill Biopharma Ltd (RDHL)

[midastouch017]

RedHill Biopharma Ltd Announces RedHill: LPI in Part A of RHB-107 P2/3 COVID Study

https://finance.yahoo.com/news/redhill-biopharma-ltd-announces-redhill-120200532.html

RedHill Biopharma Announces Last Patient Randomized in Part A of Ongoing Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients

Recruitment completed for Part A of the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care

Top-line results for Part A of the study, designed to evaluate safety and tolerability of RHB-107 and dose selection, expected in Q1/ 22

RHB-107 is a novel, investigational antiviral serine protease inhibitor targeting human cell factors and is expected to be effective against emerging viral variants

In parallel, data packages for opaganib, RedHill's other advanced novel oral COVID-19 drug candidate, have been submitted in the U.S., EU, UK and other territories, ahead of planned regulatory advice

TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / November 15, 2021 / RedHill Biopharma Ltd. (Nasdaq:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the last patient has been enrolled in Part A of the Phase 2/3 study with novel, once-daily, orally-administered pill RHB-107 (upamostat)[1] for non-hospitalized patients with symptomatic COVID-19. The study is being conducted in the U.S. and South Africa.

The Phase 2/3 study (NCT04723527) with RHB-107 is aimed at evaluating treatment in patients with symptomatic COVID-19 early in the course of the disease, with a once-daily oral treatment that can be prescribed and used in the non-hospitalized patient population. The study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of RHB-107. The study is designed to evaluate time to sustained recovery from illness as the primary endpoint and for dose selection. A total of 61 patients have been enrolled in Part A and randomized on a 1:1:1 basis to receive one of two doses of upamostat or placebo. Based on safety and tolerability results of part A, a dose for part B will be selected, and patients will be randomized 3:2 to active vs. placebo. Patients are also tested for specific viral strain. Top-line results from Part A of the study are expected in the first quarter of 2022, with Part B of the study expected to follow subsequent to discussions with regulators.

"Once again, we see a rise in COVID-19 infections in many countries across the world - and the need for effective, simple and safe oral therapies that can be used outside the hospital setting, and that can work across COVID-19 variants, is significant," said Terry F. Plasse MD, Medical Director at RedHill. "Completing randomization for Part A of the RHB-107 Phase 2/3 study is an important step forward for this elegant, once-daily novel oral pill as a potential treatment of COVID-19 in the community."

RHB-107 is a novel antiviral drug candidate 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. RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial epithelial cell model. RHB-107 has a strong clinical safety and biodistribution profile, demonstrated in previous clinical studies, including several Phase 1 and Phase 2 studies in different indications, in approximately 200 patients.

In parallel, data packages for opaganib[2], RedHill's other advanced novel oral COVID-19 drug candidate - have been submitted to regulators in various territories including the U.S., EU, UK and others, ahead of planned regulatory advice. Opaganib's global Phase 2/3 study in patients hospitalized with severe COVID-19 demonstrated a 62% reduction in mortality as well as improved outcomes in time to room air and median time to hospital discharge in a sub-group of 251 moderately severe patients, comprising 54% of the study participants.