The patents cover RedHill’s propriety formulation of its extended-release ondansetron tablet, and the way BEKINDA is used in treatment.
“We are very pleased with the allowance of two additional U.S. patents for BEKINDA,” Danielle Abramson, RedHill’s director of intellectual property and research, said in a press release. “This is an important addition to RedHill’s strong IP [intellectual property] portfolio that will further enhance our protection of BEKINDA.
“We are approaching significant milestones with BEKINDA in the coming months,” Abramson added. She was referring to the results of two ongoing clinical trials that are expected in the second and third quarters of 2017.
BEKINDA is an anti-emetic drug, or one that treats nausea and vomiting. It targets multiple gastrointestinal problems, including irritable bowel syndrome (IBS), acute gastroenteritis and gastritis. Patients take the tablet once a day.
The randomized, double-blind, placebo-controlled Phase 3 GUARD clinical trial of 24 mg of BEKINDA (NCT02246439) is continuing. It is evaluating its effectiveness and safety as a treatment for vomiting resulting from acute gastroenteritis or gastritis.
RedHill announced in February that the last of the 320 adults and children in the GUARD study had completed the treatment and observation period. Key results of the trial, which took part at 29 U.S. sites, are expected in the second quarter of 2017.
Also under way is a randomized, double-blind, placebo-controlled Phase 2 trial (NCT02757105). It is evaluating the effectiveness and safety of the 12-mg bimodal-release tablet form of BEKINDA for treating adults with IBS-related diarrhea, or IBS-D. The key results of the trial, which is being conducted at 16 U.S. sites, are expected in the third quarter of 2017.
RedHill, a Tel Aviv-based specialty biopharmaceutical company, will hold an R&D Day and live webcast on BEKINDA on April 27 in New York. It will cover what the drug is used for, the clinical trials, and potential markets.
Ondansetron is in a class of medications called serotonin 5-HT3 receptor antagonists that prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. It works by blocking the action of serotonin, a natural body chemical that can cause nausea and vomiting. It is marketed under various trade names, including GSK’s Zofran.
Redhill said BEKINDA, which it licensed from SCOLR Pharma in 2010, is the only once-a-day oral formulation of ondansetron — and is likely to be the first to reach U.S. and European markets. RedHill obtained the rights to the original ondansetron patents from Temple University after SCOLR went out of business.
RedHill now has three U.S. patents on BEKINDA, two pending American patents, 17 patents from other countries, and more than 35 pending patents outside the United States.
RedHill Biopharma Ltd.
U.S. National Library of Medicine Medline Plus
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