RedHill Biopharma Ltd. (NASDAQ:RDHL) announced that it has acted on a request to provide its opaganib treatment on an outpatient basis under compassionate use exemption for several Swiss patients suffering from coronavirus (COVID-19) pneumonia.
The specialty biopharmaceutical company noted that, acting rapidly to ensure emergency transport and supply of drug, treatment was initiated with orally-administered opaganib within the past week.
Opaganib is a novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated dual anti-inflammatory and antiviral activity, targeting a human cell component involved in viral replication and therefore expected to be effective against emerging viral variants with mutations in the spike protein.
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In a statement, Gilead Raday, RedHill's chief operating officer commented: "We continue to do all we can to support patients, and their treating physician, who are in need of treatment options for COVID-19. Having recently reported positive Phase 2 data with opaganib in the US, our ongoing global 464-patient Phase 2/3 study with opaganib for severe COVID-19 is now more than two-thirds enrolled."
The global Phase 2/3 randomized, double-blind, parallel-arm, placebo-controlled study of opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen (NCT04467840), is advancing in a total of eight countries and approximately 40 recruiting sites, the company noted
RedHill recently announced positive top-line safety and efficacy data from the non-powered US Phase 2 study with opaganib in 40 patients with COVID-19 pneumonia, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14, on top of standard-of-care. The Phase 2 data also showed no material safety differences between the opaganib and placebo on top of standard-of-care treatment arms - further adding to the growing safety database for opaganib.
A new chemical entity
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib received Orphan Drug designation from the US 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. Opaganib is also being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a 40-patient US Phase 2 study.
Preclinical data have demonstrated the anti-inflammatory and antiviral activity of opaganib, with the potential to ameliorate inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Opaganib also demonstrated reduced blood clot length, weight and total thrombus score in a preclinical model of Acquired Respiratory Distress Syndrome.
Opaganib was originally developed by US-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.
RedHill Biopharma is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. The company promotes the following gastrointestinal drugs: Movantik for opioid-induced constipation in adults, Talicia for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo for the treatment of travellers' diarrhoea in adults.
Contact the author at jon.hopkins@proactiveinvestors.com
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