RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced that the US Patent and Trademark Office (USPTO) has issued two new patents, one covering opaganib for treating Ebola virus disease, with patent protection until 2035, and the other covering RHB-104 for treating bacterial infections, with protection through 2029.
“Opaganib’s potent activity against several single-stranded RNA viruses positions it as a potential treatment for many viral diseases, including Covid-19 and other viruses that are the origin of devastating epidemics. Ebola virus disease remains a major risk with recent recurring outbreaks. Opaganib has already demonstrated positive results from non-clinical studies in Ebola, and RedHill is committed to continuing its development as a potential treatment for this devastating disease,” said Danielle T. Abramson, Ph.D., SVP, global head of intellectual property. “In addition, we continue to evaluate the potential development path to approval of RHB-104 for Crohn’s disease.”
Opaganib is also under development for Covid-19, with a 475-patient global phase 2/3 study in patients hospitalized with severe Covid-19 with patient treatment and follow-up recently completed and top-line results upcoming. In parallel, opaganib is also being studied in phase 2 US studies in cholangiocarcinoma and prostate cancer, as well as development programs for other indications.
The MAP US randomized, double-blind, placebo-controlled first phase 3 study with oral RHB-104 for Crohn’s disease successfully met both its primary endpoint and its key secondary endpoints and presented the broad benefit of RHB-104 as an add-on therapy to standard-of-care treatments for Crohn’s disease, including anti-TNFs. Future development path to approval is being explored.
RedHill Biopharma Ltd. is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases.