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A global phase of 2/3 is underway in up to 270 patients hospitalized for severe pneumonia in COVID-19, and a phase 2 in the US is underway.But it’s not the first time In up to 40 patients, with opaganib, a new selective inhibitor of oral sphingosine kinase 2 (SK2) with double anti-inflammatory and antiviral properties
Opaganib has been chosen for a grant from Pennsylvania’s COVID-19 Vaccine, Treatment and Therapies Program, which supports the immediate advancement of promising new treatments for COVID-19
TEL AVIV, Israel and RALEIGH, North Carolina, September 3, 2020 (GLOBE NEWSWIRE) – RedHill Biopharma Ltd.(Nasdaq: RDHL) (“RedHill” or “Company”), a specialized biopharmaceutical company, today announced the variety of opaganib1, an exclusive selective inhibitor of oral sphingosine kinase-2 (SK2), under evaluation for severe pneumonia remedy in COVID-19, will obtain a $300,000 grant from COVID-19 vaccines in the state of Pennsylvania, The Treatment and Therapies Program (CV- ATV), which is designed to aid the immediate advancement of new COVID-19 therapies. The grant was awarded to RedHill’s partner, Apogee Biotechnology Corporation, to whom RedHill legalized the opaganib, which will conduct the studies funded through the grant.
“We are pleased that the state of Pennsylvania has identified the promising prospect of our drug candidate opaganib 2/3 as an indispensable healing option for COVID-19 patients,” said Reza Fathi, PhD., Senior Vice President, RedHill, R
The Pennsylvania state CV-ATV grant will cover key preclinical mechanical studies to better elucide the prospective role of opaganib in the extent and/or duration of COVID-19-associated acute respiratory distress syndrome (EDS).
To date, the global phase 2/3 review comparing opaganib for the COVID-19 remedy has been approved in the UK, Italy, Russia and Mexico, with patient recruitment underway and additional planned expansion., the placebo-controlled parallel arm phase 2/3 examination (NCT04467840) is expected to recruit up to 270 patients with severe COVID-19 pneumonia requiring hospitalization and treatment with oxygen supplements.
The U.S. Phase 2 clinical examination has been conducted. But it’s not the first time About opaganib, conducted in conjunction with the global phase 2/3 exam, has more than 50% recruitment, and recruitment is expected to be completed in the coming weeks.Recently, an independent protection oversight committee pre-programmed for the review to continue unchanged.The next pre-programmed protection review is scheduled once 24 patients have completed seven days of treatment.The test, which is not motivated by statistical significance, is a randomized, double-blind, placebo-controlled test (NCT04414618) to recruit up to 40 patients with severe pneumonia in COVID-19 who require hospitalization and oxygen supplements.
Opaganib (ABC294640, Yeliva®) Opaganib, a new chemical entity, is an exclusive selective inhibitor of sphingosine kinase-2 (SK2) administered orally, with anticancer, anti-inflammatory and antiviral activities, aimed at oncology, viral, inflammatory and gastrointestinal indications when inhibiting SK2, opaganib affects several cellular pathways related to cancer growth, viral replication and pathological inflammation.
Opaganib was originally developed through the US company Apogee Biotechnology Corp.et has completed several successful preclinical studies in oncology, inflammation, radiation and GI coverage models, as well as a phase 1 clinical examination in cancer patients with complex forged tumors.
Opaganib has won the US FDA’s orphan drug designation.But it’s not the first time For the treatment of cholangiocarcinoma and is being evaluated in a phase 2a study in complex cholangiocarcinoma and in a phase 2 study in prostate cancer.Opaganib is also being evaluated as a component of a phase 2/3 program for coronavirus remedy (COVID-19).
The effects of the remedy of the first patients with severe COVID-19 with opaganib have recently been published.2 Analysis of the results of the remedy in five patients with severe COVID-19 showed a great advantage for patients treated with opaganib with compassionate use in any of the clinical outcomes and inflammatory markers compared to a paired retrospective control organization of the same hospital.All patients in the organization treated with opaganib were discharged from the hospital without the need for mechanical ventilation, while 33% of the organization of matched cases and controls required mechanical ventilation.The median wait until the weaning of the high-performance nasal cannula was reduced to 10 days in the organization treated with opaganib, compared to 15 days in the paired control organization.
Preclinical knowledge demonstrated the anti-inflammatory and antiviral activities of opaganib, with the potential to decrease inflammatory lung disorders, such as pneumonia, and alleviate pulmonary fibrotic lesions.Several previous preclinical studies on the prospective role of SK2 in the replication-transcription complex detect single-category RNA viruses, similar to coronavirus, and their inhibition would possibly inhibit viral replication prospectively.Preclinical studies in vivo2 have shown that opaganib reduces death rates from influenza virus infection and improves lung lesions induced by Pseudomonas aeruginosa by reducing the degrees of IL- 6 and TNF-alpha in bronchoalveolar washing fluids.
The progression of opaganib has been supported through grants and contracts from U.S. state and federal government agencies.But it’s not the first time Awarded to Apogee Biotechnology Corp., NCI, BARDA, the US Department of Defense, and the U.S. Department of Defense.But it’s not the first time And the FDA’s Office of Orphan Product Development.
About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily targeting gastrointestinal diseases. RedHill promotes gastrointestinal drugs, Movantik® for opioid-induced constipation in adults3, Talicia® for the remedy of Helicobacter pylori (H. pylori) infection in adults4 and Aemcolo® for the remedy of traveler’s diarrhea in adults 5. The major late clinical stage Progression systems for RedHill include: (i) RHB-204, with a fundamental phase 3 examination planned to detect pulmonary nontuberculous mycobacterial (NTM) infections; (ii) opaganib (Yeliva®), a first-class selective SK2 inhibitor targeting multiple indications with a phase 2/3 program for COVID-19 and ongoing phase 2 studies for prostate cancer and cholangiocarcinoma; (iii) RHB-104, with positive effects from a first phase 3 examination in Crohn’s disease; (iv) RHB-102 (Bekinda®), with positive effects from a phase 3 test for acute gastroenteritis and gastritis and positive effects from a phase 2 test for IBS-D; (v) RHB-106, an encapsulated bowel prep, and (vi) RHB-107, a first-pass phase 2 serine protease inhibitor, targeting cancer and gastrointestinal inflammatory disease and is also under evaluation for COVID-19. More information about the company can be found at www.redhillbio.com.
This press release comprises “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements would possibly be preceded by the words “intends”, “possibly”, “will”, “plans”, ” foresees “,” anticipates “,” projects “,” predicts “,” estimates “,” aims “,” believes “,” expects “,” prospective “or similar words. Forward-looking statements are based on safe assumptions and are subject to various known and unknown threats and uncertainties, many of which are beyond the control of the company and cannot be predicted or quantified, therefore the actual effects may differ materially from those. those expressed or implied through those forward-looking statements. These threats and insecurities include, but are not limited to, the threat of a delay in the receipt of knowledge to assist in the application of emergency use applications; the threat that the US phase 2 clinical exam comparing opaganib will not be a success and the threat that the final touch of recruitment for this clinical exam will be stopped; the threat that the Company will not adopt the phase 2/3 exam in certain geographic areas, will not extend this exam to other countries and that it will not be a success; the threat that other COVID-19 patients treated with opaganib will not show clinical improvement; the threat that clinical trials with opaganib in Israel, the United States, Italy, Russia, the United Kingdom, Mexico or elsewhere for the remedy of COVID-19, if carried out, will not show any improvement in patients; the threat of delay in requesting authorizations for emergency use; threats to expand early-stage discovery efforts for a still little-known disease, adding the difficulty of evaluating the effectiveness of opaganib for the COVID-19 remedy, if applicable; intense festival of other corporations about possible COVID-19 remedies and vaccines; the effect of a possible appearance of patients with serious adverse situations using opaganib in compassionate use programs, as well as the threats and insecurities related to (i) the initiation, timing, progress and effects of research, manufacturing, studies The Company’s preclinical and clinical trials and other drug candidate progression efforts, and the timing of advertisements for its advertising products and those that it would potentially gain or expand in the long term; (ii) the Company’s ability to promote its applicants for cure in clinical trials or to carry out its preclinical studies or clinical trials or the progression of a significant other diagnostic announcement for the detection of Mycobacterium avium subspecies paratuberculosis (MAP ); (iii) the scope, quantity and type of additional studies that the Company may be required to carry out and the receipt by the Company of regulatory approvals for its recovery applicants, and the timing of other submissions, approvals and regulatory comments; (iv) the manufacture, clinical progression, market placement and market acceptance of the Company and Talicia® applicants for cure; (v) the company’s ability to successfully position itself in the market and advertise Movantik®, Talicia® and Aemcolo®; (vi) the corporate’s ability to identify and maintain corporate collaborations; (vii) the Company’s ability to obtain successful advertising products approved for placement in markets in the United States and to expand and maintain its own market placement and advertising capabilities; (viii) the interpretation of the homes and characteristics of the Company’s applicants for cure and the effects received with their applicants for cure in research, preclinical studies or clinical trials; (ix) implementation of the Company’s business model, strategic plans for its activity and cleaning up of applicants; (x) the extent of coverage the Company can identify and maintain for the intellectual property rights covering its applicants for recovery and advertising products and its ability to operate its business without infringing the intellectual property rights of others; (xi) components to which the Company grants its high-level assets by failing to comply with their legal responsibilities towards the Company; (xii) estimates of corporate expenses, long-term income, capital needs, and additional financing needs; (xiii) the effect of patients with adverse reports who use investigational drugs as a component of the company’s expanded access program; and (xiv) festival of other corporations and technologies in the Company’s industry. The most detailed data about the company and the points of threat that could possibly be the functionality of the forward-looking statements are established in the files of the company with the Securities and Exchange Commission (SEC), adding the annual report of the company in the Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made solely as of the date of this press release. The Company assumes no legal responsibility to update any written or oral forward-looking statements, whether as a result of new data, long-term occasions or otherwise, unless required by law.
Company Contact: Adi Frish Senior Vice President of Commercial Development and Licensing RedHill Biopharma [email protected]
IR Contact (USA): Timothy McCarthy, CFA, MBA CEO, LifeSci Advisors Relationship Manager, LLC [email protected]
Opaganib (Yeliva®, ABC294640) is a new experimental drug that cannot be used for advertising distribution.2 Xia C.et al. Transient inhibition of sphingosine kinases provides coverage for mice inflamed with influenza A virus.Res.Antiviral.158: 171-177.Ebenezer DL et al. Pseudomonas aeruginosa stimulates the nuclear generation of sphingosine-1-phosphate and the epigenetic regulation of inflammatory lung lesions.Thorax.2019 Jun; 74 (6): 579-591.3 Complete dosage data for Movantik® (naloxegol) can be obtained at: www.Movantik.com.4 Complete talicia dosage data® (magnesic omeprazole, amoxicillin and rifabutin) should be obtained at: www.Talicia.com.5 Complete dosage data for Aemcolo® (rifamycin) can be obtained at: www.Aemcolo.com.