midastouch017
2 days ago
Newly Published Positive Phase 3 Data Demonstrates 64% Increased Efficacy with RedHill's RHB-104 in Crohn's Disease
https://finance.yahoo.com/news/newly-published-positive-phase-3-110000141.html
Newly published in the peer-reviewed journal Antibiotics, the 331-patient Phase 3 Crohn's disease study data shows the primary endpoint of clinical remission at week 26 was achieved, with high statistical significance, in 36.7% (61/166) of orally administered RHB-104 plus standard of care (SoC) patients, compared to 22.4% (37/165) of placebo plus SoC patients (p=0.0048); Safety profile similar to placebo. Study conducted across more than 100 sites
The advanced stage clinical data demonstrating the potential efficacy of oral RHB-104 triple antimicrobial therapy targeting Mycobacterium avium subspecies paratuberculosis (MAP,) supports the paradigm-changing hypothesis of a Mycobacterial basis to Crohn's disease, where high unmet medical need exists
"This ground-breaking data shows that RHB-104, which contains antimicrobial therapy directed against Mycobacterium paratuberculosis, or MAP, which typically infects cattle, appears to be effective for the treatment of Crohn's disease - potentially opening a new avenue of therapy directed against its possible cause," said Dr. David Y. Graham, Professor of Medicine and Molecular Virology and Microbiology at Baylor College of Medicine, the lead investigator of the study. Dr. Graham added: "It is particularly important to note that RHB-104 proved beneficial to patients receiving anti-TNF agents, corticosteroids or immunosuppressive agents, and may also have a role as an add-on therapy for patients not responding to their current treatment."
The Crohn's disease market was valued at more than $13 billion in 2023. Commonly used therapies in the treatment of Crohn's include: Abbvie's Humira® (adalimumab), Janssen's Remicade® (infliximab) and Stelara® (ustekinumab), BMS's Zeposia® (ozanimod) and Pfizer's Xeljanz® (tofacitinib)
TEL AVIV, Israel and RALEIGH, N.C., Aug. 1, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the new publication of ground-breaking positive data showing that triple antimicrobial therapy with RHB-104[1] plus standard of care (SoC), targeting Mycobacterium avium subspecies paratuberculosis (MAP), is 64% more effective than SoC alone in Crohn's disease, supporting the hypothesis of a Mycobacterial basis to the disease.
The data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of anti-mycobacterial therapy (RHB-104) in active Crohn's disease, was published in the peer-reviewed journal, Antibiotics[2]. In the global study, conducted across more than 100 sites across the U.S. Europe and other locations, a total of 166 patients were randomized to receive RHB-104 plus SoC and 165 to placebo plus SoC. Data for the primary endpoint, clinical remission at week 26, shows, with high statistical significance, that 36.7% (61/166) of RHB-104 patients achieved clinical remission at week 26 vs. 22.4% (37/165) of placebo patients (p = 0.0048). RHB-104 was found to be generally safe and well tolerated, with adverse event reporting similar to placebo. Full results are available in the publication.
"This study was designed based on the hypothesis that infection with MAP is the primary cause of Crohn's disease and that antimicrobial therapy designed to treat MAP would favorably influence the outcome of Crohn's disease," said study lead investigator, Dr. David Y. Graham, Professor of Medicine and Molecular Virology and Microbiology at Baylor College of Medicine and the Michael E. DeBakey Veterans Administration Hospital in Houston, Texas, USA. "We believe that this data shows that treatment with RedHill's RHB-104 appears to be effective for the treatment of Crohn's disease – this is important as an effective and safe oral therapy for Crohn's could be highly beneficial to the patients and treating community. A unique feature of this Phase 3 study was that patients were permitted concomitant treatment with infliximab, adalimumab and/or corticosteroids at study entry. To our knowledge, no other similar Crohn's trial has allowed tumor necrosis factor (TNF) agents to be continued throughout the treatment period. It is therefore also important to note that RedHill's RHB-104 proved beneficial to patients receiving corticosteroids, immunosuppressive agents, or anti-TNF agents and may also have a role as an add-on therapy for patients not responding to their current treatment."
"Crohn's disease causes immense suffering to millions of patients globally and sometimes leads to death due to various complications. Recognizing this, RedHill is firmly committed to the RHB-104 potential paradigm-changing Phase 3-stage program. It has been more than 100 years since Scottish surgeon, Dalziel, first sowed the seeds of a possible link between MAP and Crohn's. Evidence has grown of MAP involvement in the etiology of Crohn's, being associated with immune signaling dysregulation and being identified in over 50% of Crohn's patients," said Dror Ben-Asher, RedHill's Chief Executive Officer. "This makes the new peer-reviewed publication of these data highly exciting as Crohn's is a terrible disease that remains steadfastly resistant to the search for a cure – despite the enormous research efforts made in the field of immunosuppression. We have a long-held conviction in the MAP approach – vindicated by this compelling data. Planning ahead, the advent of an accurate and reliable MAP diagnostic, allied to this proven triple antimicrobial therapeutic strategy, has the potential to change the treatment paradigm in inflammatory bowel disease (IBD). Accordingly, we have been pursuing creative partnership models to advance the development of RHB-104 and intend to update the market in due course."
midastouch017
2 weeks ago
RedHill Biopharma Strengthens Cash Balance, Settles Obligations and Removes Talicia® Lien
https://finance.yahoo.com/news/redhill-biopharma-strengthens-cash-balance-110000660.html
TEL-AVIV, Israel and RALEIGH, NC, July 22, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the signing of a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, LLC, and HCR Redhill SPV, LLC (the "Agreement"). As a result of the Agreement, RedHill received approximately $9.9 million in cash and gained full control over an additional $0.74 million currently held in a restricted account, leading to an increase of approximately $12.2 million in liabilities for RedHill, reflecting assumed and settled liabilities between the parties, resulting in a net balance sheet reduction of approximately $2.3 million. In addition, the Agreement ends all existing credit ties with the Agreement parties, removes the existing lien against Talicia® and restores control over cash collections back to RedHill.
Razi Ingber, RedHill's Chief Financial Officer, said: "We are very pleased to reach this smooth conclusion, which strengthens RedHill's cash position and greatly enhances our ability to manage our cash. The Agreement eliminates substantially all encumbrances related to the previous Movantik divestment and Credit Agreements, allowing us to better focus on our R&D and commercial activities and return the Company to a growth mode. This is a new chapter for RedHill."
midastouch017
4 weeks ago
RedHill Biopharma Terminates License Agreement for Aemcolo®
https://finance.yahoo.com/news/redhill-biopharma-terminates-license-agreement-120000000.html
TEL-AVIV, Israel and RALEIGH, NC, July 9, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the mutual decision with Cosmo Technologies Ltd. ("Cosmo") to voluntary terminate their exclusive U.S. license agreement for Aemcolo, a treatment for traveler's diarrhea (the "License Agreement"). The License Agreement, initially dated October 17, 2019, will be officially terminated on October 8, 2024.
Per the terms of the License Agreement, RedHill will immediately cease any Aemcolo commercialization of Aemcolo upon termination of the License Agreement, at which point all rights previously ascribed in the License Agreement to RedHill will revert to Cosmo.
Rick Scruggs, RedHill's Chief Commercial Officer, said: "This decision to stop the commercialization of Aemcolo was made following careful mutual consideration and we would like to offer our sincere thanks to the Cosmo team for their partnership over the past years."
midastouch017
2 months ago
RedHill Announces a New Patent Covering Opaganib in Combination with Immune Checkpoint Inhibitors, Valid Through 2040
https://finance.yahoo.com/news/redhill-announces-patent-covering-opaganib-110000734.html
New Chinese patent notice of allowance issued covering opaganib in combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response[1]. Provides protection for opaganib's potential use in combination with a range of approved and in-development (ICIs) across a growing range of indications[2] through 2040
ICIs have become a cornerstone in cancer treatment, having been hailed as a major breakthrough by oncologists, with the global ICI market expected to exceed $100 billion by 2028, including Merck's Keytruda (pembrolizumab) and BMS' Yervoy (ipilimumab)[3]
Opaganib, a host-directed and potentially broad acting twice-daily oral, small molecule with a demonstrated safety & efficacy profile, is in development for multiple oncology, viral and inflammatory indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and two U.S. government-sponsored countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure
TEL-AVIV, Israel and RALEIGH, N.C., June 3, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new Chinese patent notice of allowance for opaganib[4] in combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response, providing protection for opaganib's potential use with a range of approved and in-development immune checkpoint inhibitors (ICIs) across a growing range of indications through 2040. The patent will be issued by the Chinese National Intellectual Property Administration (CNIPA) (Chinese Patent Application No.: 202080013805.3 issued May 24, 2024).
"ICIs have become a cornerstone in cancer treatment, having been hailed as a major breakthrough by oncologists, with the global ICI market expected to exceed $100 billion by 2028, including Merck's Keytruda (pembrolizumab) and BMS' Yervoy (ipilimumab)," said Guy Goldberg, RedHill's Chief Business Officer. "This exciting new patent is based on compelling data from a range of in vivo experiments showing significant improvements in outcomes in combination with selected ICIs. China has been a world leader in embracing ICI-based therapy[5] and this is an important addition to the strong patent portfolio protecting opaganib."
About Opaganib (ABC294640)
Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential diseases, including prostate cancer and cholangiocarcinoma (bile duct cancer), gastrointestinal acute radiation syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola and other viruses as part of pandemic preparedness.
Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).
Opaganib has been selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure, both funded by the NIH: The Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the HHS National Institutes of Health, for the nuclear medical countermeasures (MCM) product development pipeline selected opaganib for development as a potential treatment for Acute Radiation Syndrome (ARS); and the Chemical Medical Countermeasures (Chem MCM) Program and Chemical Countermeasures Research Program (CCRP), managed respectively by the Administration for Strategic Preparedness and Response (ASPR) / Biomedical Advanced Research and Development Authority (BARDA) and NIH/NIAID selected opaganib for evaluation as a potential medical countermeasure (MCM) against Sulfur Mustard exposure.
Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.
Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in medRxiv.
Opaganib has received Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.
Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[6], and Aemcolo®, for the treatment of travelers' diarrhea in adults[7]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with U.S. government collaborations for development for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure, a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
More information about the Company is available at www.redhillbio.com / twitter.com/RedHillBio.
midastouch017
3 months ago
RedHill Announces New Opaganib Chinese Patent Against Ebola Virus Valid Through 2035
https://finance.yahoo.com/news/redhill-announces-opaganib-chinese-patent-110000975.html
The new Chinese patent for opaganib as a therapy for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus) is valid through 2035 and adds to opaganib's strong global intellectual property portfolio across multiple indications
--
U.S. Army studies suggest that opaganib may be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival; separately, opaganib demonstrated robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability
--
A host-directed and potentially broad acting twice-daily oral, small molecule, opaganib is in development for multiple indications, including COVID-19, acute respiratory distress syndrome, oncology and two U.S. government-sponsored countermeasures programs for Acute Radiation Syndrome and Sulfur Mustard exposure. It has a demonstrated safety and efficacy profile, and is well-suited to counter nuclear / chemical exposure and viral pandemic scenarios, being viral mutation-resistant, and easy to administer and distribute
TEL-AVIV, Israel and RALEIGH, N.C., May 6, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new Chinese patent Notice of Allowance covering opaganib[1] as a therapyg for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus) from the Chinese National Intellectual Property Administration (CNIPA), valid through 2035 (Chinese Patent Application No.: 202110229970.9 issued April 29, 2024).
"This new patent adds to the existing intellectual property portfolio protecting opaganib across multiple indications and represents the first China patent in the Ebola patent family," said Guy Goldberg, RedHill's Chief Business Officer. "U.S. Army studies suggest that opaganib may be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival. Targeting multiple indications, including selection by two U.S. government countermeasures programs for Acute Radiation Syndrome and Sulfur Mustard exposure, oral opaganib, has a demonstrated safety and efficacy profile and is well-suited to viral pandemic scenarios, being viral mutation-resistant, and easy to administer and distribute."
About Ebola virus disease:
According to the Centers for Disease Control and Prevention (CDC), Ebola disease is a rare and often deadly illness, caused by infection by one of a group of four viruses, known as ebolaviruses, that are found primarily in sub-Saharan Africa and are known as: Zaire, Sudan, Taï Forest (formerly Côte d'Ivoire) and Bundibugyo. Transmission of the disease is mostly through contact with an infected animal (bat or nonhuman primate) or a sick or dead person infected with an ebolavirus. The course of the illness typically progresses from "dry" symptoms initially (such as fever, aches and pains, and fatigue), and then progresses to "wet" symptoms (such as diarrhea, vomiting and unexplained hemorrhaging, bleeding or bruising) as the person becomes sicker. There are currently only two FDA-approved therapies to treat EVD caused by the Ebola virus, species Zaire ebolavirus, in adults and children; Inmazeb™ (atoltivimab/maftivimab/odesivimab, Regeneron Pharmaceuticals, Inc), a combination of three monoclonal antibodies and Ebanga™ (ansuvimab-zykl, Ridgeback Biotherapeutics, LP), a single monoclonal antibody. Both are intravenously infused direct acting monoclonal antibody antivirals that bind to glycoproteins on the Ebola virus's surface to prevent the virus from entering a person's cells. There is an urgent need for host-directed small molecule therapies that may be effective against multiple strains of ebolavirus, less likely to be impacted by viral mutation, and that are easy to store, distribute and administer, especially in areas where healthcare services and infrastructures may be sub-optimal.
midastouch017
3 months ago
RedHill Announces First Patient Enrolled in U.S. Government-Supported COVID-19 Study
https://finance.yahoo.com/news/redhill-announces-first-patient-enrolled-110000993.html
First patient enrolled in the global, 300-patient, Phase 2 adaptive platform trial arm of RHB-107 (upamostat)1 for early COVID-19 outpatient treatment, funded through non-dilutive external sources, including the U.S. Department of Defense
The study is expected to be completed by the end of 2024
RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including marked reduction in hospitalization due to COVID-19 in a U.S. Phase 2 study2
RHB-107 is a novel, oral, once-daily, host-directed potential broad-acting antiviral expected to act independently of viral spike protein mutations3
RALEIGH, N.C. and TEL-AVIV, Israel, April 24, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the first patient has been enrolled in the Austere environments Consortium for Enhanced Sepsis Outcomes' (ACESO) U.S. government-supported PROTECT multinational platform trial for early COVID-19 outpatient treatment. RHB-107 (upamostat) is the first drug being tested in this platform study. Funded through non-dilutive external sources, including the U.S. Department of Defense, the PROTECT study is expected to be conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by the end of 2024.
"Enrollment of the first patient in the study marks an important milestone for RHB-107 in the 300-patient U.S. government-supported PROTECT platform study, which could add significant validating data to the previous marked reduction in hospitalizations due to COVID-19 seen in the RHB-107 arm of our earlier U.S. Phase 2 study," said Gilead Raday, RedHill's Chief Operating Officer and Head of R&D. "RHB-107 is a novel, potentially broad-acting, host-directed antiviral that is expected to act independently of viral spike protein mutations. If approved, RHB-107 could provide a much-needed additional option for use in the early COVID-19 treatment space, alongside Paxlovid. Additionally, with both RHB-107 and opaganib recently demonstrating distinct synergistic effect when combined individually with remdesivir in an in vitro Ebola study, we are making encouraging progress with our pipeline assets for pandemic preparedness."
Data from RHB-107's previous U.S. Phase 2 study showed a 100% reduction in hospitalization due to COVID-19, with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized for COVID-19 on the placebo-controlled arm (nominal p-value=0.0317). The study also showed an approximately 88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with 2.4% of the RHB-107 treated group (1/41) versus 20% (4/20) of patients in the placebo-controlled arm (nominal p-value=0.036) reporting new severe COVID-19 symptoms. Further post-hoc analysis showed faster recovery periods from severe COVID-19 symptoms with a median of 3 days to recovery with upamostat compared to 8 days with the placebo.
The ACESO PROTECT study is an adaptive, randomized, double blind, multi-site Phase 2 platform trial, being conducted by researchers from ACESO and partner organizations, and administered by the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF). The study will compare investigational products (IPs) to control, in standard-risk, non-hospitalized adult SARS-CoV-2 infected participants with at least two moderate-severe symptoms at baseline. RHB-107 is the initial drug being evaluated in the early treatment arm of the study. The primary efficacy assessment in the early treatment indication will be time to sustained alleviation or resolution of COVID-19 symptoms. Participants will be followed for a period of up to 12 weeks.
Selection of IPs for inclusion in the ACESO PROTECT study is based on review of the preclinical and early clinical data, evaluating safety, tolerability, and efficacy. Selection is also based on route of administration and product availability.
RHB-107's development for COVID-19 runs parallel to the development of opaganib, RedHill's other novel oral drug, for Acute Radiation Syndrome, being done in collaboration with, and funded by, the U.S. government's National Institutes of Health Radiation and Nuclear Countermeasures Program. Both RHB-107 and opaganib also recently demonstrated distinct synergistic effect when combined individually with remdesivir, significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, once-daily orally administered investigational antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 is well tolerated; in the initial COVID-19 study, among 41 patients only one reported a drug-related adverse reaction (a mild, self-limited, rash).
In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients[4].
RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, 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), now celebrating its 40th anniversary, is a global nonprofit organization with the mission to advance military medicine. HJF's scientific, administrative and program operations services empower investigators, clinicians, and medical researchers around the world to make discoveries in all areas of medicine. HJF serves as a trusted and responsive link between the military medical community, federal and private partners, and the millions of warfighters, veterans, and civilians who benefit from military medicine. For more information, visit www.hjf.org.
About ACESO
The Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO) aims to improve survival for patients with sepsis in resource-limited settings through development of host-based technology solutions and evidence-based clinical management strategies. Founded in 2010, ACESO brings together a consortium comprised of academic, non-profit, governmental, and industry partners that is administered by HJF. ACESO has established a global clinical research network to develop and deliver cutting-edge tools and strategies to save lives in austere settings.
For more information, visit www.aceso-sepsis.org.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo®, for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
More information about the Company is available at: www.redhillbio.com / twitter.com/RedHillBio.
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