RedHill Biopharma Ltd, a specialty biopharmaceutical company, today announced the selection of opaganib 1, a patented, first-class, orally administered selective sphingosine kinase-2 (SK2) inhibitor under evaluation for the treatment of severe pneumonia associated with COVID-19 disease, to receive a grant of 300,000 USD from the Pennsylvania State of Pennsylvania Vaccines, Treatments and Therapies (CV-VTT) COVID-19 Program, which aims to support rapid advancement of new COVID treatments -19. The grant was awarded to RedHill's partner, Apogee Biotechnology Corporation, which will conduct the research supported by the grant, and whose opaganib has been licensed by RedHill.

"We are delighted that the State of Pennsylvania has recognized the promising potential of our Phase 2/3 drug candidate, opaganib, as an essential treatment option for patients with COVID-19," said Reza Fathi , PhD., Senior Vice President of R&D at RedHill. “This grant will accelerate and expand the development of opaganib towards our goal of generating a robust data set to potentially support emergency use claims against COVID-19. "

The Pennsylvania State CV-VTT grant will cover key preclinical mechanistic research to better understand the potential role of opaganib in suppressing the extent and / or duration of related acute respiratory distress syndrome (ARDS). to COVID-19.

To date, the global Phase 2/3 study evaluating opaganib for the treatment of COVID-19 has been approved in the UK, Italy, Russia and Mexico, with patient enrollment ongoing and further expansion is planned. The multicenter, randomized, double-blind, parallel-arm, placebo-controlled phase 2/3 study ( NCT04467840 ) is expected to enroll up to 270 patients with severe pneumonia related to COVID-19 disease requiring hospitalization and additional oxygen supply.

Registrations for the US phase 2 clinical study of opaganib, running alongside the global phase 2/3 study, are over 50% complete, and are expected to close in the coming weeks . Recently, an independent pre-programmed safety oversight committee recommended that the study continue without change. The next pre-scheduled safety review should take place after 24 patients have completed seven days of treatment. This study, which is not designed for statistical significance, is a randomized, double-blind, placebo-controlled study ( NCT04414618 ), enrolling up to 40 patients with

About opaganib (ABC294640, Yeliva ® )
Opaganib is a novel chemical entity consisting of a selective, orally administered, class 1, patented sphingosine kinase-2 (SK2) inhibitor with anti-cancer, antiviral and anti-inflammatory activities, targeting several oncological, viral, inflammatory and gastrointestinal indications. By inhibiting the SK2 receptor, opaganib affects several cellular pathways associated with tumor growth, viral replication, and pathological inflammation.

Opaganib was originally developed by Apogee Biotechnology Corp. based in the United States, and has completed several successful preclinical studies in oncology, inflammatory, gastrointestinal and radiation protection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors.

Opaganib has received an "orphan drug" designation from the US FDA for the treatment of cholangiocarcinoma, and is being evaluated in a phase 2a study in advanced cholangiocarcinoma, as well as in a phase 2 study in prostate cancer. Opaganib is also being evaluated in a phase 2/3 program for the treatment of coronavirus (COVID-19). 

The results of opaganib treatment of the first patients with severe form of COVID-19 disease were recently published 2. Analysis of treatment outcomes in five patients with severe COVID-19 disease demonstrated significant benefit for patients treated with opaganib in compassionate use both as regards clinical findings and inflammatory markers compared to a matched case-control group from the same hospital. All patients in the opaganib group discharged from hospital without the need for mechanical ventilation, while 33% of patients in the matched case-control group required mechanical ventilation. The median time to weaning from the high-flow nasal cannula was reduced to 10 days in the opaganib group, compared to 15 days in the matched case-control group.

Preclinical data demonstrated the antiviral and anti-inflammatory properties of opaganib, as well as the potential for reducing inflammatory pulmonary disorders such as pneumonia, and reducing pulmonary fibrogenic lesions. Several preclinical studies demonstrate the potential role of the SK2 channel in the reproduction-transcription complex of positive-polarity single-stranded RNA viruses, similar to the coronavirus, and its inhibition could stop virus replication. Preclinical in vivo studies 2 have shown that opaganib reduces the death rate from influenza virus infection and improves lung damage induced by pseudomonas aeruginosa by reducing the levels of IL-6 and TNF-alpha present in bronchoalveolar lavage fluids.

The development of opaganib was supported by grants and contracts awarded to the American company Apogee Biotechnology Corp. through US government and federal agencies, including the NCI, BARDA, the US Department of Defense, and the FDA Orphan Drug Development Bureau.

About RedHill Biopharma
RedHill Biopharma Ltd. is a specialty biopharmaceutical company, primarily focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs Movantik ® for constipation caused by opioids in adults 3 , Talicia ® for the treatment of Helicobacter pylori (H. pylori) infection in adults 4 and Aemcolo ® for the treatment traveler's diarrhea in adults 5 . RedHill's main advanced clinical development programs include: (i) RHB-204, with a pivotal phase 3 study planned for non-tuberculous pulmonary mycobacterial infections; (ii) opaganib (Yeliva ® ) , a first-in-class selective SK2 inhibitor targeting multiple indications, with a phase 2/3 program for COVID-19 disease and ongoing phase 2 cancer studies prostate and cholangiocarcinoma; (iii) RHB-104 , with positive results from the first phase 3 study for Crohn's disease; (iv) RHB-102 ( Bekinda ®), with positive results from a phase 3 study for gastroenteritis and acute gastritis and positive results from the phase 2 study for irritable bowel syndrome with diarrhea; (v) RHB - 106 , a capsule intestinal preparation, and (vi) RHB-107 , a first class phase 2 serine protease inhibitor, targeting cancers and inflammatory gastrointestinal diseases, and which is also being evaluated as a treatment for COVID-19 disease. More information about the Company is available at www.redhillbio.com .

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects, ”“ Anticipates, ”“ projects, ”“ predicts, ”“ estimates, ”“ aims, ”“ believes, ”“ hopes, ”“ potential ”or similar words. 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 Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk of a delay in receiving data to support applying for emergency use applications; the risk that the US Phase 2 clinical study evaluating opaganib will not be successful and the risk that completion of enrollment for this clinical study will be delayed; the risk that the Company will not initiate the Phase 2/3 study in certain geographies, will not expand this study in additional countries and that it will not be successful; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the risk that clinical trials with opaganib in Israel, the US, Italy, Russia, the UK, Mexico or elsewhere for the treatment of COVID-19, if conducted at all, will not show any improvement in patients; the risk of a delay in applying for emergency use authorizations; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials , and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of Mycobacterium avium subspecies paratuberculosis (MAP); (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia® ; (v) the Company's ability to successfully commercialize and promote Movantik ® , Talicia ®  and Aemcolo ®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the US that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

NOTE: This press release, circulated for convenience, is a translated version of the press release issued by the Company in English.

Company Contact:
Adi Frish
Vice President, Development and Licensing
RedHill Biopharma
+ 972-54-6543-112
adi@redhillbio.com    IR Contact (US):
Timothy McCarthy, CFA, MBA
Managing Director, Relationship
Manager LifeSci Advisors, LLC
+ 1-212-915-2564
tim@lifesciadvisors.com

1  Opaganib (Yeliva ® , ABC294640) is an investigational new drug that is not available for commercial distribution.
2  Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. Oct. 2018; 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.
3 Complete prescribing information for Movantik ® ( naloxegol ) is available at: www.Movantik.com .
4Complete prescribing information for Talicia ® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com .
5  Complete prescribing information for Aemcolo ® (rifamycin) is available at: www.Aemcolo.com .

 

Source: globenewswire.com

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