Opaganib

RedHill's Opaganib Selected for Evaluation by BARDA and NIH Countermeasures Programs

Retrieved on: 
Tuesday, March 5, 2024
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The overall evaluation will also include assessment of opaganib's efficacy against sub-chronic fibrosis and acute respiratory distress syndrome (ARDS) resulting from Sulfur Mustard exposure.

Key Points: 
  • The overall evaluation will also include assessment of opaganib's efficacy against sub-chronic fibrosis and acute respiratory distress syndrome (ARDS) resulting from Sulfur Mustard exposure.
  • "With the alarming increase in global geo-political instability, the opportunity to evaluate opaganib as a potential vital protective agent against chemical attack is inspiring.
  • "Opaganib is the first selective sphingosine kinase-2 (SPHK2) inhibitor investigational drug targeting sphingolipid metabolism to be evaluated as a chemical countermeasure.
  • Opaganib, a novel oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute for use against potential chemical weapon attack, if approved by the FDA.

RedHill's Opaganib Protects Against Radiation-Induced Lung Inflammation and Fibrosis - New Publication

Retrieved on: 
Tuesday, February 20, 2024
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The published data shows that opaganib2 protects against radiation-induced lung inflammation and fibrosis in an in vivo mouse model of lung damage following exposure to ionizing radiation, demonstrating its potential use as a medical countermeasure against nuclear irradiation and in cancer radiotherapy.

Key Points: 
  • The published data shows that opaganib2 protects against radiation-induced lung inflammation and fibrosis in an in vivo mouse model of lung damage following exposure to ionizing radiation, demonstrating its potential use as a medical countermeasure against nuclear irradiation and in cancer radiotherapy.
  • Radiation-induced inflammation is known to occur in two phases – in an initial inflammatory response immediately after irradiation and in a delayed response that can occur weeks later.
  • Thus, treating with opaganib during both initial and delayed phases of inflammation provided the greatest improvement in survival.
  • "These data further demonstrate that sphingolipid metabolism is a critical regulator of fibrogenesis, and specifically show that opaganib suppresses radiation-induced pulmonary inflammation and fibrosis."

RedHill Accelerates Opaganib's Nuclear Radiation Protection Program - Positive Data Published

Retrieved on: 
Monday, November 14, 2022
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The publication highlights observations from numerous studies undertaken in both protection against radiation toxicity and cancer radiotherapy settings.

Key Points: 
  • The publication highlights observations from numerous studies undertaken in both protection against radiation toxicity and cancer radiotherapy settings.
  • Much of the damage caused by radiation exposure is caused by inflammation secondary to the effects of ionizing radiation itself known as Acute Radiation Syndrome.
  • Again, opaganib was not associated with a diminished tumor response to fractionated radiation treatment and increased weight loss from radiation treatment was not observed.
  • Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv .

RedHill Reports Potent Inhibition of Omicron with Oral COVID-19 Drug Candidate Opaganib In Vitro

Retrieved on: 
Monday, April 11, 2022
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TEL AVIV, Israel and RALEIGH, N.C., April 11, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced study results in which opaganib (ABC294640)1, a leading oral drug candidate for hospitalized patients with moderate to severe COVID-19, was observed to have potent in vitro efficacy against the Omicron SARS-CoV-2 variant, while maintaining host cell viability. Based on the new and previously announced data, opaganib's unique human host-targeted, dual antiviral and anti-inflammatory suggested mechanism is expected to act independently of viral spike protein mutations and remain effective against Omicron sub-variants BA.2, XE and other emerging and future variants.

Key Points: 
  • Opaganib was studied in a global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840).
  • Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, 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.
  • All forward-looking statements included in this press release are made only as of the date of this press release.

RedHill and Kukbo Enter Oral Opaganib License for COVID-19 in South Korea

Retrieved on: 
Tuesday, March 15, 2022
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TEL-AVIV, Israel, and RALEIGH, N.C., March 15, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced that it has entered into an exclusive license agreement with Kukbo Co. Ltd. (Kospi: 001140) ("Kukbo"), a South Korean corporation, for oral opaganib[1] for the treatment of COVID-19, in South Korea.

Key Points: 
  • TEL-AVIV, Israel, and RALEIGH, N.C., March 15, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced that it has entered into an exclusive license agreement with Kukbo Co. Ltd. (Kospi: 001140) ("Kukbo"), a South Korean corporation, for oral opaganib[1] for the treatment of COVID-19, in South Korea.
  • Kukbo will receive the exclusive rights to commercialize opaganib in South Korea for COVID-19.
  • Together with our partner, Kukbo, we are working hard to bring opaganib to Korean patients in need of new COVID-19 therapeutic options."
  • "With the data supporting opaganib for COVID-19, and the expanded partnership with RedHill, Kukbo is determined to work with local regulators with the aim of bringing opaganib to South Korean patients, as soon as possible."

RedHill Biopharma's Oral Opaganib Reduces Mortality by 70% Given on Top of Remdesivir and Corticosteroids in Severe COVID-19

Retrieved on: 
Monday, February 7, 2022
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The first analysis showed that opaganib significantly reduced mortality when given to patients who received remdesivir and corticosteroids, the best available standard-of-care (SoC) for hospitalized patients.

Key Points: 
  • The first analysis showed that opaganib significantly reduced mortality when given to patients who received remdesivir and corticosteroids, the best available standard-of-care (SoC) for hospitalized patients.
  • Oral opaganib has now shown an ability to reduce deaths, speed up recovery and clear viral RNA, all with a safety and tolerability profile similar to placebo.
  • "The hospitalized moderate to severe COVID-19 patient group is estimated to represent more than 50% of all hospitalized COVID-19 cases and growing.
  • Oral opaganib was studied in a global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840).

RedHill Biopharma Announces Last Patient Randomized in Part A of Ongoing Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients

Retrieved on: 
Monday, November 15, 2021
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TEL AVIV, Israel and RALEIGH, N.C., Nov. 15, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the last patient has been enrolled in Part A of the Phase 2/3 study with novel, once-daily, orally-administered pill RHB-107 (upamostat)[1] for non-hospitalized patients with symptomatic COVID-19. The study is being conducted in the U.S. and South Africa.

Key Points: 
  • The study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of RHB-107.
  • The study is designed to evaluate time to sustained recovery from illness as the primary endpoint and for dose selection.
  • 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.
  • RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients.

RedHill Biopharma Announces Last Patient Randomized in Part A of Ongoing Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients

Retrieved on: 
Monday, November 15, 2021
Cancer, Opioid, Rifabutin, Security (finance), FSE, Gastritis, COVID-19, IBS-D, Vii, Ix, Opaganib, Infection, Cell, Redhill, Risk, Gastroenteritis, Magnesium, Mortality, Safety, Trial of the century, Research, Forward-looking statement, Amoxicillin, NTM, U.S. Securities and Exchange Commission, Omeprazole, Marketing, Patient, Feedback, Helicobacter pylori, Genta (company), Private Securities Litigation Reform Act, Protease, Disease, Crohn's disease, Xi, Vaccine, SEC, TEL, Prostate cancer, Severe acute respiratory syndrome coronavirus 2, ABC294640, Cholangiocarcinoma, Diarrhea, Annual report, Atmosphere, Authorization, HPHA, Company, Nasdaq, Medicare Part D, Pharmaceutical industry

TEL AVIV, Israel and RALEIGH, N.C., Nov. 15, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the last patient has been enrolled in Part A of the Phase 2/3 study with novel, once-daily, orally-administered pill RHB-107 (upamostat)[1] for non-hospitalized patients with symptomatic COVID-19. The study is being conducted in the U.S. and South Africa.

Key Points: 
  • The study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of RHB-107.
  • The study is designed to evaluate time to sustained recovery from illness as the primary endpoint and for dose selection.
  • 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.
  • RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients.

RedHill Biopharma Reports Top-Line Data from Opaganib Phase 2/3 Study in Severe COVID-19 Patients

Retrieved on: 
Tuesday, September 14, 2021
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Top-line safety data showed good tolerability of opaganib, with balanced adverse events between the study arms.

Key Points: 
  • Top-line safety data showed good tolerability of opaganib, with balanced adverse events between the study arms.
  • Phase 2 study and the previously observed antiviral activity of opaganib.
  • "We would like to thank the patients, physicians and supporting medical staff who took part in this important study.
  • The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study enrolled 475 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen.

RedHill Biopharma Further Expands Opaganib Manufacturing Capacity for COVID-19 with Cosmo Pharmaceuticals

Retrieved on: 
Thursday, January 28, 2021
Opaganib, Cosmo, Kinase

TEL AVIV, Israel and RALEIGH, N.C., Jan. 28, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced a manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN) ("Cosmo") to further expand manufacturing capacity for opaganib (Yeliva, ABC294640)[1], to address prospective demand subsequent to potential global emergency use authorizations.

Key Points: 
  • TEL AVIV, Israel and RALEIGH, N.C., Jan. 28, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced a manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN) ("Cosmo") to further expand manufacturing capacity for opaganib (Yeliva, ABC294640)[1], to address prospective demand subsequent to potential global emergency use authorizations.
  • "We are very pleased to expand the manufacturing capacity of opaganib with a partner of Cosmo's quality.
  • Opaganib is a Phase 2/3-stage novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity.
  • Cosmo has licensed Aemcolo to RedHill Biopharma for the US and has licensed Relafalk to Dr. Falk Gmbh for the EU and other countries.