RedHill Biopharma Ltd (RDHL)

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RedHill's RHB-102 (BEKINDA®) and Opaganib Granted New Patents in Oncology Setting

https://finance.yahoo.com/news/redhills-rhb-102-bekinda-opaganib-110000092.html

European Patent Office grants RHB-102 patent covering antiemetic extended-release solid dosage forms for the prevention of nausea and vomiting (CINV/RINV), providing protection of RHB-102 to March 2034

Discussions with potential commercialization partners for RHB-102 in the UK and other territories are ongoing

US PTO grants new opaganib combination compositions patent for treatment of cancer

TEL AVIV, Israel and RALEIGH, N.C., May 1, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the granting of two new EU and U.S. patents for RHB-102 (BEKINDA)1 and opaganib2, respectively, in the oncology setting.

The European Patent Office granted RHB-102 (BEKINDA), a 24-hr bimodal release, once-daily oral tablet formulation of ondansetron, a patent covering antiemetic extended-release solid dosage forms for the prevention of nausea and vomiting (CINV/RINV). The patent provides the potential for UK and EU protection of RHB-102 to March 2034.

"Between 70-80% of patients undergoing chemotherapy or radiotherapy will experience nausea and/or vomiting. The global CINV/RINV market is growing at approximately 6% CAGR and is estimated to be worth over $10 billion by 20313," said Guy Goldberg, RedHill's Chief Business Officer. "Following a positive recent UK MHRA scientific advice meeting RHB-102 (BEKINDA) data was deemed supportive of potential submission for marketing approval in the UK for chemotherapy and radiotherapy induced nausea and vomiting (CINV/RINV). The Company is also considering the potential for RHB-102 in additional territories and discussions with potential commercialization partners in the UK and other territories are ongoing."

Additionally, the U.S. Patent and Trademark Office (USPTO) has granted a new patent for opaganib in respect to combination compositions for treatment of cancer, extending protection to October 2036.

About RHB-102 (BEKINDA):

RHB-102 is a proprietary, bimodal release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting several gastrointestinal indications. RHB-102 24 mg is intended to provide patients with relief from nausea and vomiting symptoms for a full 24-hour period with a single oral tablet. If approved for marketing by the MHRA, RHB-102 24 mg could become the first oral 24hr extended-release 5-HT3 antiemetic drug in the UK indicated for the treatment of CINV/RINV.

Positive results from two successful late-stage RHB-102 studies at different doses, the U.S. Phase III GUARD gastroenteritis study (RHB-102 24 mg) and the U.S. Phase II IBS-D study (RHB-102 12 mg) were published in JAMA Network Open3 and The American Journal of Gastroenterology4, respectively.

About Opaganib (ABC294640)
Opaganib, a new chemical entity, is an orally administered, first-in-class proprietary selective inhibitor of sphingosine kinase-2 (SK2) with suggested anti-inflammatory, anticancer, radioprotective and antiviral activity.

Opaganib 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 (SK2, DES1 and GCS).

Opaganib was recently selected by the U.S. Government's Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS). As part of this collaboration, contractors directed and supported by the RNCP will undertake studies, designed in collaboration with RedHill, to test opaganib in established ARS models. In an ARS setting, opaganib is thought to exert its protective effects via an anti-inflammatory mechanism of action involving ceramide elevation and reduction of sphingosine 1-phosphate (S1P) in human cells - suppressing inflammatory damage to normal tissue and thus suppressing toxicity from unintended ionizing radiation exposure. It has also been reported in the literature that inhibition of sphingosine kinase 2 promotes the viability and robustness of hematopoietic stem cells, even in the face of radiation damage, supporting increased survival.

Opaganib has received Orphan Drug designation from the U.S. 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 IND submission.

Opaganib has demonstrated broad-acting, host-directed, antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A. 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. Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv.

Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.