redhill-biopharma-expands-us.-production-capacity-of-opaganib-for-covid-19
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RedHill adds two more manufacturing partners, both based in the U.S., for large-scale production of opaganib, in preparation for potential emergency use authorization applications as early as Q1 2021

The new collaborations follow the recent communication on partnerships with European and Canadian producers

Enrollment completed for Phase II study in the United States â ???? top-line data expected for the next few weeks; over 50% enrolled for the Phase II / III global parallel study â ???? top-line data expected for the first quarter of 2021Â

Promising new mechanism of action of opaganib potentially minimizes the likelihood of resistance due to viral mutations

TEL AVIV, Israel and RALEIGH, NC, Nov 30, 2020 / PRNewswire / – RedHill Biopharma Ltd. (Nasdaq: RDHL) (‘RedHill’ or ‘Company’), a specialty biopharmaceutical company, today announced its partnership with two major manufacturers for large-scale production of opaganib[1]. These collaborations mark a further step in ongoing preparations to support potential authorization applications for the emergency use of opaganib in the treatment of severe COVID-19 pneumonia, expected in the first quarter of 2021. The new collaborations follow the recent communication on partnerships with European and Canadian producers.

‘We are expanding our U.S. manufacturing capacity for orally administered opaganib with a view to potential emergency use authorization applications as early as Q1 2021,’ said Reza Fathi, PhD., Senior VP, R&D by RedHill. ‘Coupled with our recent announcement of similar collaborations in Europe and Canada and in light of the rapid development of our Phase II / III opaganib program for COVID-19, these new partnerships in the United States enable RedHill to better position itself for meet the potential demand for opaganib, if authorized. ‘

Opaganib is a novel orally administered selective sphingosine kinase-2 (SK2) inhibitor with proven dual anti-inflammatory and antiviral activity that acts on the cause and effect of COVID-19 disease by targeting a component of the host cell involved in viral replication, potentially reducing the likelihood of resistance due to viral mutations.

The enrollment in the global Phase II / III study of 270 patients with opaganib in patients with severe COVID-19 pneumonia (NCT04467840) exceeded 50%. The study, approved in six countries, is expected to provide top-line data in the first quarter of 2021. This study is focused on and prepared for efficacy evaluation; It recently received a unanimous recommendation to continue from an Independent Data Safety Monitoring Committee (DSMB), following a pre-planned safety assessment of the first 70 patients who received treatment for 14 days. In the coming weeks, the DSMB will also conduct a preprogrammed non-blinded interim analysis to justify continuation, which will evaluate data from the first 135 subjects who met the primary endpoint.

The parallel Phase II study in the USA with opaganib (NCT04414618) has completed the enrollment of all 40 subjects, top line data are expected for the next few weeks. This study is not designed for efficacy evaluation and focuses on safety evaluation and identification of efficacy signs.

Information on opaganib (ABC294640, Yeliva®) Â

Opaganib, a new chemical entity, is a proprietary, first-in-class, orally administered selective inhibitor of sphingosine kinase-2 (SK2) with proven dual anti-inflammatory and antiviral activity that targets a component of the host cell. potentially minimizing the likelihood of resistance due to viral mutations. Opaganib has also shown antitumor activity and has multiple potential oncological, viral, inflammatory and gastrointestinal indications.

Opaganib is also being evaluated in a global Phase II / III study and a Phase II study in the United States for the treatment of severe COVID-19 pneumonia. Opaganib has also received orphan drug designation from the US FDA for the treatment of cholangiocarcinoma and is being evaluated in a phase IIA study in advanced cholangiocarcinoma and a phase 2II study in prostate cancer.

Preclinical data demonstrated both the anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate fibrotic lung damage. Opaganib has demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, by completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Also, in vivo preclinical studies[2] demonstrated that opaganib reduced the lethality rates of influenza virus infection and improved lung lesions due to Pseudomonas aeruginosa by reducing IL-6 and TNF-alpha levels in bronchoalveolar lavages.

Opaganib was originally developed by US-based Apogee Biotechnology Corp. and has completed several successful preclinical studies in cancer, inflammatory, GI and radiation protection models, as well as a Phase 1 clinical trial in cancer patients with tumors. advanced solids and a further Phase 1 study in multiple myeloma.

As part of a compassionate use program, patients with severe COVID-19 (according to the WHO ordinal scale classification) were treated with opaganib at a major hospital in Israel. Data from the treatment of these first severe COVID-19 patients with opaganib have been published [3]. Analysis of treatment outcomes suggests a real benefit for patients treated with opaganib in compassionate use in terms of both clinical outcomes and inflammatory markers compared to a retrospective control group of similar cases from the same hospital. All patients in the opaganib group were discharged from hospital with natural breathing without the need for intubation and mechanical ventilation, while 33% of the corresponding control group of similar cases required intubation and mechanical ventilation. The mean weaning time from the high-flow nasal cannula was reduced to 10 days in the opaganib group, compared to 15 days in the corresponding case control group.

The development of opaganib was supported by grants and contracts from US federal and state government agencies awarded to Apogee Biotechnology Corp., including the NCI, BARDA, the US Department of Defense and the FDA office for development of orphan products.

Ongoing studies with opaganib are registered at http://www.ClinicalTrials.gov, a web-based service of the US National Institute of Health, which provides public access to information on public and private funded clinical trials.

About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialized biopharmaceutical company, primarily focused on gastrointestinal and infectious diseases. RedHill promotes gastrointestinal medication, Movantik® for opioid-induced constipation in adults[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5] and Aemcolo® for the treatment of traveler’s diarrhea in adults[6]. RedHill’s major advanced clinical development programs include: (i) RHB-204, with an ongoing Phase III study for non-tuberculous mycobacterial lung disease (NTM); (ii) opaganib (Yeliva®), an innovative multi-indication selective SK2 inhibitor with a Phase II / III program for COVID-19 and Phase II trials for prostate cancer and ongoing cholangiocarcinoma; (iii) RHB-104, with positive results from an initial Phase III study for Crohn’s disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase III study for gastroenteritis and acute gastritis and positive results from a Phase II study for IBS-D; (v) RHB-107 (upamostat), a phase 2 seroprotease inhibitor, with a Phase II / III study planned for symptomatic COVID-19 targeting multiple other forms of cancer and inflammatory gastrointestinal diseases; and (vi) RHB-106, an encapsulated gut preparation. More information about the company is available on the website http://www.redhillbio.com.

NOTE: This press release, provided for convenience, is a translated version of the official press release published by the Company in the English language. For the full press release in English, including forward-looking disclaimers, please visit: https://ir.redhillbio.com/press-releases.

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