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First patient enrolled in the Phase 2 global adaptive platform test group of 300 patients of RHB-107 (upamostat)1 for early outpatient treatment of COVID-19, funded through non-dilutive external sources, the U. S. Department of Defense added. U. S.
It is expected to be completed by the end of 2024.
RHB-107 effectively met the number one endpoint of protection and tolerability and provided promising efficacy results, adding marked relief in COVID-19 hospitalizations in a U. S. Phase 22 study. U. S.
RHB-107 is a new, broad-acting, once-daily host-targeted antiviral that is expected to act independently of mutations in the viral spike protein3.
RALEIGH, N. C. and TEL-AVIV, Israel, April 24, 2024 /PRNewswire/ — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, announced today that the first patient has been enrolled in the Consortium for Improved Sepsis Outcomes (ACESO) multinational PROTECT platform trial. for austere environments, with the support of the U. S. government. The U. S. Department of Health and Human Services (CDC) has been approved for the early outpatient treatment of COVID-19. RHB-107 (upamostat) is the first drug tested in this platform study. Funded through non-dilutive external sources, including the U. S. Department of Defense. In the U. S. , the PROTECT study is expected to be conducted in the United States, Thailand, Côte d’Ivoire, South Africa, and Uganda, and is expected to be completed by the end of 2024. .
“The enrollment of the first patient in the study marks a milestone for RHB-107 in the U. S. government-supported 300-patient PROTECT platform study. “This could add significant validation data to the larger marked relief in COVID-19 hospitalizations observed in the RHB-107. arm of our previous Phase 2 study in the U. S. ,” said Gilead Raday, chief operating officer and chief operating officer and chief R&D officer.
Data from the latest Phase 2 study of RHB-107 in the U. S. The U. S. Centers for Disease Control and Prevention showed 100 percent relief in COVID-19 hospitalizations, with 0 patients (0/41) in the RHB-107 group compared to 15% (3/20) hospitalized with COVID-19 in the placebo-controlled group (nominal P value = 0. 0317). The study also showed approximately 88% relief in new severe COVID-19 symptoms reported after starting treatment, with 2. 4% of the RHB-107 organization (1/41) compared to 20% (4/20) of patients in the placebo organization. The controlled arm (nominal p-value = 0. 036) reported new severe COVID-19 symptoms. Further post hoc investigations showed faster recovery periods from severe COVID-19 symptoms, with a median of 3 days to recovery with upamostat, compared to 8 days with placebo.
The ACESO PROTECT study is an adaptive, randomized, double-blind, multi-site Phase 2 trial led by ACESO investigators and partner organizations, and administered through the Henry M. Foundation Army. Jackson for the Advancement of Medicine (HJF). The study will compare investigational products (IPs) with non-hospitalized adult control participants with SARS-CoV-2 at common risk, with at least two moderate to severe symptoms at baseline. RHB-107 is the first drug evaluated in the first treatment arm of the study. The number one assessment of efficacy in early indication of the remedy will be the time needed to sustainably alleviate or alleviate the symptoms of COVID-19. Participants will be followed for a period of up to 12 weeks.
The range of PIs for inclusion in the ACESO PROTECT study depends on the review of preclinical and early clinical data, comparing safety, tolerability, and efficacy. The selection also depends on the direction of administration and availability of the product.
The progression of RHB-107 for COVID-19 parallels the progression of RedHill’s other new oral drug, opaganib, for acute radiation syndrome, which is conducted and funded collaboratively through the U. S. government’s National Institutes of Health’s Nuclear and Radiation Countermeasures program. U. S. Centers for Disease Control and Prevention (CDC) has also recently demonstrated a distinctive synergistic effect when combined separately with remdesivir, particularly potency while maintaining cell viability, in an in vitro Ebola study funded and conducted by the U. S. Army. U. S.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-of-its-kind, once-daily oral research antiviral that targets human serine proteases involved in preparing the spike protein for virus access to target cells. Because it targets the host cell, RHB-107 is also expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is well tolerated; In the original COVID-19 study, out of 41 patients, one reported a drug-related adverse reaction (a mild, self-limiting rash).
In addition, RHB-107 inhibits several proteases that attack cancer and gastrointestinal inflammatory diseases. RHB-107 has been studied in several Phase 1 and two Phase 2 studies, demonstrating its clinical protection profile in approximately two hundred patients [4].
RedHill has acquired exclusive international rights to RHB-107, China, Hong Kong, Taiwan and Macau, from Germany’s Heidelberg Pharma AG (FSE: HPHA) (formerly WILEX AG) for all indications.
About HJF
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF), which today celebrates its 40th anniversary, is a global non-profit organization whose project is to promote military medicine. The scientific, administrative, and operational aspects of the HJF systems enable medical researchers, physicians, and researchers from around the world to make discoveries in all areas of medicine. HJF provides a trusted and responsive link between the military’s medical community, federal and personal partners, and the millions of combatants, veterans, and civilians. who derive advantages from military medicine. For more information, visit www. hjf. org.
About ACESO
The Consortium for Lean Environments to Improve Sepsis Outcomes (ACESO) aims to improve the survival of patients with sepsis in resource-limited settings through the progression of host-based generation responses and evidence-based clinical control methods. Founded in 2010, ACESO brings together a combination of a consortium of academic, nonprofit, government and industry partners, managed through HJF. ACESO has established a global clinical trial network to expand and deliver life-saving equipment and methods in austere environments.
For more information, www. aceso-sepsis. org.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company focused primarily on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal medications 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 lead clinical progression systems include: (i) opaganib (ABC294640), a first-of-its-kind, broad-acting, host-targeted oral SPHK2 inhibitor with prospective pandemic readiness, targeting multiple indications with a US Government Acute Progression Collaborative. radiation syndrome (ARS), a Phase 2/3 COVID-19 hospitalized program and a Phase 2 oncology program; (ii) RHB-107 (upamostat), an oral broad-acting host-targeted serine protease inhibitor with pandemic preparedness perspective, is in complex stages of progression as a remedy for non-hospitalized symptomatic symptoms of COVID-19 , with a non-dilutive remedy. . external investment covering the entire RHB-107 portion of the 300-patient Phase 2 adaptive trial, which also targets other cancers and inflammatory gastrointestinal diseases; (iii) RHB-102, with prospective presentation in the United Kingdom for nausea and vomiting induced by chemotherapy and radiotherapy, positive effects from a phase 3 study for acute gastroenteritis and gastritis and positive effects from a phase 2 study for IBS-D ; (iv) RHB-104, with positive effects from an initial phase 3 study for Crohn’s disease; and (v) RHB-204, a Phase 3 program for nontuberculous mycobacterial (NTM) lung disease.
More information about the company can be found at: www. redhillbio. com/twitter. com/RedHillBio.
Forward-Looking Statements
This press release comprises “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be preceded by the words “intends,” “possibly,” “will,” “plans,” ” expects”, “anticipates”, “projects”, “predicts”, “estimates”, “targets”, “believes”, “expects”, “potential” 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 Company’s control and cannot be predicted or quantified. Therefore, actual effects would likely differ materially from those expressed or implied by such forward-looking statements. These threats and uncertainties come with, but are not limited to, the threat that the ACESO PROTECT exam for RHB-107 will not be completed or, if completed, will not be a success or even if it is a success. They constitute sufficient help for regulatory requests, adding emergency requests. use or advertising, that further COVID-19 studies will most likely be required for RHB-107 and that we will not be able to discharge further non-dilutive progression funding for RHB-107. These threats and uncertainties also come with those related to the threat that the Company will not be successful in advertising its products, that the expansion of recipes will not continue and that new generative products will not be added, and that we will not be able to increase our sells. of our advertising products, added as a result of market and other conditions; as well as threats and insecurities related to (i) the initiation, timing, progress and effects of the research, manufacturing, preclinical studies, clinical trials and other advancement efforts of the Company’s cure applicants, as well as the time of announcement. launch of its advertising products and those that it would possibly gain or expand in the long term; (ii) the Company’s ability to advance its cure applicants to clinical trials or to successfully complete its preclinical studies or clinical trials, the progression of an announcement and other significant diagnostics for the detection of MAP; (iii) the scope, number and type of additional studies that the Company would potentially be required to conduct and the Company’s receipt of regulatory approvals for its cure applicants, as well as the timing of other regulatory submissions, approvals and comments; (iv) the manufacturing, clinical progression, advertising and market acceptance of the Company’s and Talicia® cure applicants; (v) the Company’s ability to successfully create a market for and promote Talicia® and Aemcolo®; (vi) the Company’s ability to identify and maintain corporate collaborations; (vii) the Company’s ability to obtain products approved for sale in the United States that are successful in advertising and to expand its own advertising and market placement capabilities; (viii) the interpretation of the properties and characteristics of the Company’s cure applicants and the effects discharged with its cure applicants in the context of research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its businesses and curation of applicants; (x) the extent of coverage that the Company is able to identify and maintain for intellectual asset rights covering its cure applicants and its ability to conduct its business without violating the intellectual asset rights of others; (xi) parties to whom the Company licenses its intellectual assets fail to meet their legal responsibilities to the Company; (xii) estimates of the Company’s expenses, long-term revenues, capital needs and additional financing needs; (xiii) the effect of patients experiencing adverse reports while using investigational drugs under the Company’s expanded access program; (xiv) festival of other corporations and technologies within the Company’s industry, and (xv) the date of hiring and graduation of employment of senior executives. More detailed information about the Company and the threats that could possibly affect the realization of the forward-looking statements are set forth in the Company’s filings with the Securities and Exchange Commission (SEC), adding to the Company’s annual report on Form 20-F filed with the Securities and Exchange Commission (SEC). SEC on April 28, 2023. All forward-looking statements included in this press release are made only as of the date of this press release. The Company undertakes no legal responsibility to update any written or oral forward-looking statements, whether as a result of new data, long-term developments or otherwise, unless required by law.
This task was supported through the Executive Office for Biotechnology Activation Executive Office (JPL CBRND EB) Joint Project Manager of the Joint Chemical, Biological, Radiological and Nuclear Defense Program (JPEO-CBRND), in collaboration with the Defense Health Agency (DHA) COVID Funding Initiative for the Henry M. Foundation. Jackson for the Advancement of Military Medicine, Inc. , contract W911QY-20-9-0004 for this effort.
The perspectives expressed in this press release reflect the effects of the author’s studies and necessarily reflect the official policy or position of Henry M. Jackson for the advancement of medicine from the Army, Inc. , the Department of the Navy, the Department of the Army. , the Department of Defense, or the U. S. Government. References to non-federal entities or their products constitute or signify endorsement through the Department of Defense or the military of any company, organization, or product. To the Company’s knowledge, the examiner’s protocol complies with all applicable federal regulations governing the coverage of human subjects.
Company Contact:
Adi Frish
Director of Corporate and Commercial Development
RedHill Biopharmacy
972-54-6543-112
adi@redhillbio. com
Category: R
[1] RHB-107 (upamostat) is an investigational new drug that is not available for advertising distribution in the United States.
[2] https://www. ijidonline. com/article/S1201-9712(22)00638-5/fulltext
[3] Preliminary insights from a recent in vitro study
[4] https://www. ijidonline. com/article/S1201-9712(22)00638-5/fulltext
[5] Talicia® (magnesium omeprazole, amoxicillin, and rifabutin) is indicated for the treatment of H. pylori infection in adults. For complete prescribing information, see: www. Talicia. com.
[6] Aemcolo® (rifamycin) is indicated for the treatment of traveler’s diarrhea caused by noninvasive strains of Escherichia coli in adults. For complete prescribing information, see: www. aemcolo. com.
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