RedHill Biopharma Ltd (RDHL)

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RedHill Announces New H. pylori and COVID-19 Data Publication and Presentations at Leading Upcoming Scientific Conferences

https://finance.yahoo.com/news/redhill-announces-h-pylori-covid-120000893.html

Talicia® - World Gastro 2022 congress (August 17-18): RedHill invited to give prestigious oral presentation of important data detailing high eradication rates across body mass index (BMI) groups with Talicia, the U.S.'s leading brand for Helicobacter pylori (H. pylori) eradication treatment - invitation sent to researchers with significant recently published clinical findings

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Opaganib for COVID-19 – Suggested host-directed mechanism of action described in Drug Design, Development and Therapy journal: Multi-faceted potential to: Inhibit spike protein-ACE2 binding, Akt signaling and endocytosis, induce autophagy and apoptosis, and disrupt the viral replication-transcription complex (RTC) through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SK2, DES1 and GCS) - supports hypothesis of broad antiviral effect and attenuation of multi-organ dysfunction in COVID-19 patients

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Opaganib for COVID-19 - 2nd ARDS Drug Development Summit (July 13-15): Presenting new COVID-19 biomarker methodology utilizing baseline Fraction of Inspired Oxygen (FiO2) as a new disease severity classification paradigm - Phase 2/3 data demonstrating a 62% reduction in mortality in opaganib-treated patients requiring FiO2 up to 60% to be presented
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Opaganib and RHB-107 (upamostat) for COVID-19 - International Conference on Emerging Infectious Diseases (ICEID, August 7-10): Presenting promising efficacy and safety data for RedHill's novel, oral, variant-agnostic investigational COVID-19 therapies, at ICEID, the premier infectious disease conference hosted by the CDC and the Global Task Force for Health


RALEIGH, N.C. and TEL AVIV, Israel, July 12, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the upcoming presentation of new Talicia® H. pylori eradication data as well as publication and presentation of data from the opaganib and RHB-107 (upamostat) late clinical-stage COVID-19 programs at important medical congresses in July and August, 2022.

Talicia[1]: Publication of a study entitled "Helicobacter pylori Eradication by Low-Dose Rifabutin Triple Therapy (Talicia®) is Unaffected by High Body Mass Index" in the journal GastroHep has been selected by reviewers for oral presentation at the World Gastro 2022 congress, August 17-18. Such invitations to present are reserved for researchers with significant clinical findings published over the previous year. This post hoc analysis of 269 patients from the ERADICATE Hp and ERADICATE Hp2 Phase 3 clinical trials, demonstrated that Talicia is highly effective in eradicating H. pylori irrespective of patient BMI, including in obese and severely obese patients, compared to the active comparator (P<0.0001). Patients with a BMI between 30-40 kg/m2 and those with BMI >40kg/m2 treated with Talicia achieved eradication rates of approximately 90% (88.1% and 90.9% respectively) versus active comparator rates of 62.9% and 31.8% respectively - an approximately 50% lower eradication rate in the severely obese group for the active comparator. Talicia is the leading U.S. branded prescription medicine for H. pylori eradication.

Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer, said: "Because more than 70% of Americans are either overweight or obese[2], and because increased BMI has been linked to reduced eradication outcomes of many commonly used H. pylori therapies, this important work supports Talicia as a rational first line option regardless of patient BMI."

RedHill's novel, oral, variant-agnostic late clinical-stage COVID-19 drug candidates, opaganib and RHB-107, have had data selected for publication or presentation as follows:

Opaganib[3]: Suggested host-directed mechanism of action described in a manuscript entitled "Recent Progress in the Development of Opaganib for the Treatment of COVID-19" accepted for publication in the journal Drug Design, Development and Therapy: The paper outlines opaganib's multi-faceted potential to: inhibit spike protein-ACE2 binding, Akt signaling and endocytosis, induce autophagy and apoptosis, and disrupt the viral RTC (replication-transcription complex) through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SK2, DES1 and GCS). These mechanisms support the hypothesis of broad antiviral effect and attenuation of multi-organ dysfunction in COVID-19 patients. Moreover, because of this tripartite targeting, viral resistance to opaganib is unlikely to be encountered through adaptive mutation during therapy or random mutation to generate additional viral variants.

2nd ARDS Drug Development Summit, Boston, July 13-15: Data to be presented from the opaganib Phase 2/3 study showing the potential for a new methodology for selecting COVID-19 patients for treatment with opaganib, based on a new paradigm for classification of disease severity utilizing baseline Fraction of Inspired Oxygen (FiO2), in which opaganib demonstrated a 62% reduction in mortality in patients requiring FiO2 up to 60%.

Opaganib and RHB-107 (upamostat)[4]: International Conference on Emerging Infectious Diseases (ICEID), Atlanta, August 7-10: Data to be presented at ICEID, the premier infectious disease conference hosted by the CDC and the Global Task Force for Health, will include: Prespecified analyses from opaganib's Phase 2/3 study (NCT04467840), showing improved viral RNA clearance, faster time to recovery and reduced mortality in key subpopulations of opaganib treated moderate to severe hospitalized patients with COVID-19. Data for RHB-107, from Part A of its two-part Phase 2/3 study in a non-hospitalized setting, includes demonstration of a 100% reduction in hospitalization due to COVID-19 and an approximately 88% reduction in reported new severe COVID-19 symptoms after treatment initiation.

Dr. Mark Levitt, RedHill's Chief Scientific Officer said: "Acceptance for publication and presentation of these important data is testament to the quality and strength of RedHill's R&D capability. Oral opaganib and oral RHB-107, both of which have novel host-targeting antiviral mechanisms, have shown effect across multiple variants and virus models, and could serve as important tools in responding to the current and future pandemic waves, whether caused by SARS-COV-2 variants or by other viruses, and of particular concern, as Fall/Winter approach, is the specter of both COVID-19 and influenza circulating in abundance. We are seeing a shift in focus of government funding sources, public health experts, institutions and industry towards looking for broad host-directed antiviral mechanisms of action that will not be subject to resistance by viral mutation and that could address emerging new variants of SARS-CoV-2 and also combat other viruses that might create future pandemic waves - a more sustainable long-term approach than having to rediscover and reinvent very specific antiviral therapeutics which quickly become obsolete in the face of rapidly mutating viruses."

About H. pylori infection
H. pylori is a bacterial infection that affects approximately 35%[5] of the U.S. population, with an estimated two million patients treated annually[6]. Worldwide, more than 50% of the population has

H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[7] and a major risk factor for peptic ulcer disease[8] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[9]. More than 27,000 Americans are diagnosed with gastric cancer annually[10]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[11].

About Talicia
Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address H. pylori's high resistance to other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.

Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[12] to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm[13].

Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.

About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, investigational sphingosine kinase-2 (SK2) selective inhibitor, with suggested dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and, based on data accumulated to date, is expected to maintain effect against emerging viral variants, having already shown in vitro inhibition against variants of concern, including Omicron and Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

In prespecified analyses of Phase 2/3 clinical data, oral opaganib has 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. Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv. Opaganib previously delivered promising U.S. Phase 2 data in patients with moderate to severe COVID-19, published in Open Forum Infectious Diseases.

Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in the prostate cancer study are ongoing.

Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to decrease renal fibrosis, have shown decreased fatality rates from influenza virus infection, and amelioration of bacteria-induced pneumonia lung injury with reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[14].

The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

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 being evaluated in a Phase 2/3 study for treatment of patients with symptomatic COVID-19 who do not require inpatient care. 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. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.