Health RedHill Biopharma Releases First New Information About Its Opaganib...

RedHill Biopharma Releases First New Information About Its Opaganib Hardship Program at COVID-19 in Israel | 04/15/20

Objective improvement in the first two patients treated with opaganib in Israel who showed measurable clinical improvement within days of starting treatment, including reduced additional oxygen demand, decreased CRP (C-reactive protein) and increased lymphocyte levels.


One patient was treated in the intensive care unit, considered for intubation, and discharged within days of starting treatment.

Opaganib was given in addition to standard treatment, including background treatment with hydroxychloroquine, and was well tolerated.

The unique mechanism of action of opaganib shows both antiviral and anti-inflammatory effects that target a critical host factor and minimize the potential development of resistance due to viral mutations.

The hardship program was approved in Italy – it is planned to treat 160 patients; Discussions are ongoing in the US and other countries to improve opaganib accessibility through similar programs and to increase the number of potential clinical emergency development programs.

TEL-AVIV (Israel) and RALEIGH, NC (USA), April 15, 2020 (GLOBE NEWSWIRE) – RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a company that focuses on the development of special biopharmaceuticals, has first new information on its hardship program with its investigational medication Opaganib (Yeliva®, ABC294640)1 published in Israel in patients with confirmed SARS-CoV-2 infection (COVID-19).

The first two patients were treated with opaganib in a leading hospital in Israel. At the start of treatment, both patients had moderate to severe acute respiratory symptoms associated with SARS-CoV-2 infection, required additional oxygenation, and were hypoxic, even though cannulas provided maximum oxygen flow.

Preliminary results from both patients showed clinical improvement within days of starting opaganib treatment. So far, both patients have shown reduced additional oxygen requirements and decreased CRP (C-reactive protein) levels, an important inflammatory biomarker that correlates with lung lesions that may reflect the severity of the disease.2nd Both patients also showed an increase in lymphocyte levels, a sign of relief from virus-induced lymphopenia. One patient was treated in the intensive care unit, considered for intubation, and discharged from the intensive care unit within days of starting opaganib treatment.

Opaganib was administered to inpatients in addition to the treatment standard, which included hydroxychloroquine (HCQ) as background therapy. Opaganib was well tolerated at the doses administered and no side effects related to treatment with opaganib have been reported.

“We are very encouraged by the preliminary results showing clinical improvement in the first opaganib-treated COVID-19 patients. These data continue to support patient safety and potential benefits. We hope that the unique mechanism of action of With both antiviral and anti-inflammatory effects, Opaganib helps COVID-19 patients by reducing pneumonia, preventing the disease from moving to a stage that requires mechanical ventilation, and it is important that Opaganib targets a critical host factor, which is Coronavirus is unlikely to be able to avoid mutation in the event of future pandemic outbreaks so Dr. Mark L. Levitt, medical director at RedHill. “We are committed to expanding the availability of opaganib to other hospitals and countries as part of the hardship program and hope that this treatment can potentially benefit COVID-19 patients with life-threatening characteristics.”

In addition, approximately 160 patients in three major hospitals in northern Italy are to be treated as part of an expanded access program approved by the Italian National Institute for Infectious Diseases that will allow patients with confirmed SARS-CoV-2 infection with life-threatening characteristics of the Compassionate Use treatment option can benefit.

For more information on Redhill Biopharma’s Extended Accessibility Policy, please visit: www.redhillbio.com/expandedaccess.

Discussions are ongoing in the United States and other countries to improve opaganib accessibility through hardship program approvals and potential clinical emergency development programs.

A total of 131 subjects and patients have been administered in ongoing and completed Phase I and Phase II clinical trials for oncological indications in the United States – pharmacokinetic studies on healthy volunteers in the United States and as part of existing FDA-approved accessibility requests from Physicians to individual oncology patients to ensure human safety and tolerability both in the United States and outside the United States.

Opaganib, a new chemical, is a proprietary, first-in-class, orally administered, selective sphingosine kinase-2 (SK2) inhibitor with anti-cancer, anti-viral and anti-inflammatory properties that target various oncological, inflammatory and gastrointestinal indications. Preclinical data have shown both antiviral and anti-inflammatory effects of opaganib, with the potential to alleviate inflammatory lung diseases such as pneumonia and mitigate pulmonary fibrotic damage. Several previous preclinical studies support the potential role of SK2 in the replication-transcription complex of single-stranded positive-stranded RNA viruses that resemble coronavirus, and its inhibition may inhibit virus replication. Preclinical In vivo-Studies3rd have shown that opaganib reduces and reduces the number of deaths from infection with the influenza virus Pseudomonas aeruginosa relieves induced lung injuries.

Opaganib has undergone a Phase I clinical trial in patients with advanced solid tumors and is currently being studied individually and in combination with hydroxychloroquine in a Phase I / IIa study of advanced cholangiocarcinoma (bile duct cancer) and a Phase II study of prostate cancer.

The development of Opaganib was supported by grants and contracts from U.S. federal and state government agencies to the U.S.-based Apogee Biotechnology Corp. were awarded, including the U.S. National Cancer Institute (NCI), the U.S. Department of Health’s Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Defense, and the FDA Office of Orphan Products Development.

Via Opaganib (ABC294640, Yeliva®)
Opaganib, a new chemical, is a proprietary, first-in-class, orally administered, selective sphingosine kinase-2 (SK2) inhibitor with anti-cancer, anti-viral and anti-inflammatory properties that target various oncological, inflammatory and gastrointestinal indications. By inhibiting SK2, opaganib blocks the synthesis of sphingosine-1-phosphate (S1P), a lipid signaling molecule that promotes cancer growth and pathological inflammation. By inhibiting SK2, opaganib potentially blocks the viral replication complex and pathological inflammation. Opaganib, originally developed by Apogee Biotechnology Corp. has successfully completed several preclinical studies with oncology, inflammation, digestive tract and radiation protection models, as well as a phase I clinical study in cancer patients with solid, advanced tumors. Opaganib has been granted orphan drug status for the treatment of bile duct carcinoma by the FDA. Opaganib is also being evaluated for the treatment of coronavirus (COVID-19) in patients with confirmed COVID-19 infection in Israel – and is also to be evaluated in Italy. The development of Opaganib was supported by grants and contracts from U.S. federal and state government agencies to Apogee Biotechnology Corp. were awarded, including the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a biopharmaceutical company that specializes in gastrointestinal diseases. RedHill promotes gastrointestinal medication Movantik® against opioid-induced constipation in adults4th, Talicia® to treat infections with Helicobacter pylori (H. pylori) in adults5 and Aemcolo® to treat traveler’s diarrhea in adults6. RedHill’s key late-stage clinical development programs include: (i) RHB-104, with positive results from a first phase III study in Crohn’s disease, (ii) RHB-204, with a planned phase III approval study for lung infections with non-tuberculous mycobacteria (NTM), (iii) RHB-102 (Bekinda®), with positive results from a phase III study in acute gastroenteritis and gastritis and positive results from a phase II study in irritable bowel syndrome (IBS-D), (iv) Opaganib (Yeliva®), a “first-in-class” selective SK2 inhibitor targeting multiple oncological, inflammatory and gastrointestinal indications, with an ongoing phase I / IIb study in cholangiocarcinoma, (v) RHB106, an encapsulated drug for bowel preparation and (vi) RHB-107, a “first-in-class” serine protease inhibitor ready for phase II, which works against cancer and inflammatory gastrointestinal diseases. More information about the company can be found at www.redhillbio.com.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may include the words “intends”, “may”, “will”, “plans”, “expects”, “anticipates”, “projects”, ” predicts, “” estimates, “” targets, “” believes, “” hopes, “” potentially “or similar words, including forward-looking statements regarding the preliminary results of the treatment of COVID-19 patients with opaganib, the company’s discussions to improve the accessibility of opaganib with the approval of hardship programs and as part of potential clinical emergency development programs. Treatment with opaganib in Israel is carried out as part of a hardship program in accordance with the guidelines of the Israeli Ministry of Health. More patients are expected to be treated in the coming days. The results so far are only preliminary, based on clinical results from a very limited number of patients and are not part of a clinical trial. There is no guarantee that these patients will continue to show clinical improvement or that other patients will show a similar clinical improvement. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the control of the company and which cannot be predicted or quantified, so actual results may differ materially from those expressed by such forward-looking statements or be hinted at. These risks and uncertainties include, without limitation, that the clinical condition of the two patients cannot improve and worsen, the risk that other COVID-19 patients treated with opaganib show no clinical improvement, and the risk that clinical trials will Opaganib as a treatment for COV-19, if performed, could show no improvement in patients who are at risk of developing early-stage discovery efforts for an as yet poorly understood disease, including the difficulty in determining the effectiveness of Opaganib for the treatment of COVID-19 when at all to judge; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effects of a possible occurrence of patients suffering from serious adverse events when using opaganib as part of a hardship program, as well as the risks and uncertainties associated with (i) the start, schedule, progress and results of research, manufacture , preclinical studies, clinical trials and other efforts by the company to develop therapeutic candidates and the timing of the commercial introduction of the company’s commercial products and the products it may acquire or develop in the future; (ii) the Company’s ability to successfully bring its therapeutic candidates into clinical trials or complete its preclinical or clinical trials or the development of a companion commercial diagnostic to detect MAP (Mycobacterium avium paratuberculosis); (iii) the scope, number, and type of additional studies that the Company may need to perform, obtaining regulatory approvals for its therapeutic candidates, and the schedule for other regulatory filings, approvals, and feedback; (iv) the manufacture, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates and Talicia®; (v) the company’s ability to Talicia®, Aemcolo® and Movantik® successfully market and promote; (vi) the ability of the company to establish and maintain business partnerships; (vii) the Company’s ability to acquire commercialized products for commercial success in the United States and to build its own marketing and marketing capabilities; (viii) the interpretation of the properties and characteristics of the company’s therapeutic candidates and the results obtained with the therapeutic candidates in research, preclinical studies or clinical trials; (ix) implementing the company’s business model and strategic plans for its business and therapeutic candidates; (x) the scope of protection the company may set up and maintain for the intellectual property rights covered by its therapeutic candidates and its ability to conduct its business without violating the intellectual property rights of others; (xi) parties to whom the Company grants intellectual property licenses and who fail to meet their obligations to the Company; (xii) estimates of the company’s expenditures, future earnings, capital requirements and additional financial resources; (xiii) the effects of patients suffering from undesirable experiences with investigational medicinal products under the company’s extended access program; (xiv) competition from other companies and technologies within the company’s industry; and (xv) the date of hiring and starting executive employment.
More detailed information about the company and the risk factors that may affect the realization of forward-looking statements is provided in the company’s filings with the Securities and Exchange Commission (SEC), including the company’s annual report on Form 20-F, which was filed on April 4 March 2020 was filed with the SEC. All forward-looking statements in this press release apply only as of the date of this press release. The company assumes no obligation to update written or oral forward-looking statements, whether based on new information, future events or for other reasons, unless this is required by law.

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.

Company contact:
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+ 972-54-6543-112
[email protected]
Investor contact (USA):
Timothy McCarthy, CFA, MBA
Managing Director, Relationship Manager
LifeSci Advisors, LLC
+ 1-212-915-2564
[email protected]

___________________

1 Opaganib is a new investigational drug that is not available for commercial distribution.
2nd Ling W. C-reactive protein levels in the early stage of COVID-19. Med Mal Infect. 2020 Mar 31.pii: S0399-077X (20) 30086-X.
3rd Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158: 171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun; 74 (6): 579-591.
4th For full prescribing information for Movantik® (naloxegol), see: www.Movantik.com.
5 Complete prescribing information for Talicia® (Omeprazole Magnesium, Amoxicillin and Rifabutin) can be found at: www.Talicia.com.
6 Complete prescribing information for Aemcolo® (Rifamycin) can be found at: www.Aemcolo.com.

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