TEL AVIV, Israel and RALEIGH, N.C. - RedHill Biopharma Ltd. (NASDAQ: NASDAQ:RDHL), in collaboration with Apogee (NASDAQ:APOG) Biotechnology Corporation, has announced the U.S. government's selection of opaganib for evaluation as a potential countermeasure against Sulfur Mustard exposure.
The Chem MCM Program, run by BARDA, and the CCRP, managed by NIH/NIAID, will oversee the assessment, which also includes opaganib's effects on sub-chronic fibrosis and ARDS resulting from such exposure.
Sulfur Mustard, a chemical warfare agent, causes severe blistering and damage to the skin, eyes, lungs, and other organs, with the potential for fatal outcomes. The testing of opaganib aims to find treatments for these severe symptoms.
Opaganib is a novel oral small molecule and the first SPHK2 inhibitor drug targeting sphingolipid metabolism to be evaluated in this context. The drug has previously been accepted into the U.S. government's Radiation and Nuclear Countermeasures Program for ARS, suggesting its potential across different types of chemical injuries.
The pill has a five-year shelf-life and is considered easy to administer and distribute, which could be beneficial in the event of a chemical weapons attack, pending FDA approval.
Additionally, opaganib is being developed for multiple indications, including COVID-19, ARDS, and oncology. Its host-directed action is believed to work through the inhibition of various pathways, potentially disrupting viral replication and inducing autophagy and apoptosis.
The drug has demonstrated safety and tolerability in over 470 individuals across multiple clinical studies and has shown antiviral activity against SARS-CoV-2 and other viruses. It has also received Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma.
This announcement is based on a press release statement.
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