The South African Health Products Regulatory Authority (SAHPRA) has approved 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
Number of U.S. sites for the study has also been expanded
RHB-107, a novel antiviral serine protease inhibitor targeting human cell factors, is expected to be effective against emerging viral variants
RHB-107 is being developed as a potential treatment with a simple once-daily oral pill in the early course of COVID-19
In parallel RedHill's leading oral COVID-19 therapeutic, opaganib, is being evaluated in a global Phase 2/3 study in 475 patients hospitalized with severe COVID-19, with top-line results upcoming
RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that South Africa has joined the U.S. in approving the Phase 2/3 study with novel, once-daily, orally-administered pill RHB-107 (upamostat) for non-hospitalized patients with symptomatic COVID-19. The study is already ongoing in the U.S., with expansion of study sites underway to further accelerate recruitment.
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.
"South Africa continues to face an onslaught of COVID-19 that is claiming many lives and causing significant distress to the healthcare system. South Africa, along with the U.S. and rest of the world, urgently need the ability to easily and effectively treat COVID-19 and its variants, both inside and outside the hospital setting," said Terry F. Plasse MD, Medical Director at RedHill. "As clearly highlighted recently by the Director of NIAID, it is important to be able to treat patients early in the course of the disease to prevent progression to more severe symptoms. The approval of this study in South Africa, along with the expansion of study sites in the U.S., are aimed at accelerating our efforts to bring RedHill's two novel, oral compounds that cover the spectrum of COVID-19 disease severity, RHB-107 and opaganib, to patients across the world."
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 simple once-daily oral treatment that can be prescribed and used in the largest, 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 for dose selection and to evaluate time to sustained recovery from illness as the primary endpoint. Patients are also tested for specific viral strain.
In parallel, top-line results are upcoming from the opaganib global 475-patient Phase 2/3 study in patients hospitalized with severe COVID-19 - RedHill's other advanced COVID-19 oral drug candidate.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, orally-administered antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. RHB-107 targets human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a Phase 2/3 study for treatment of patients with symptomatic COVID-19 who do not require inpatient care. In addition, RHB-107 has potential in several indications in oncology, inflammatory and gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik(R) for opioid-induced constipation in adults, Talicia(R) for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo(R) for the treatment of travelers' diarrhea in adults. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib ( ABC294640), a first-in-class, oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.
NOTE: This press release, provided for convenience purposes, is a translated version of the official press release published by the Company in the English language. For full press release in English language, including the forward-looking statements disclaimer, please visit: https://ir.redhillbio.com/press-releases.
1. RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution in the United States.
2. Opaganib (ABC294640) is an investigational new drug, not available for commercial distribution in the United States.
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