Antibe Therapeutics has announced that it has received approval from Health Canada to initiate a Phase 2, double-blind, gastrointestinal endoscopy trial for its lead drug ATB-346.
The study will involve a total of 240 healthy volunteers, who will be randomised to one of two groups. One group will be treated for 14 days with ATB-346 (250 mg once daily), while the other group will be treated for 14 days with the standard prescription dose of naproxen (500 mg twice daily), which is one of the most prescribed nonsteroidal anti-inflammatory drug in the US.
Upper gastrointestinal endoscopy will be performed prior to drug treatment, and at the end of the 14-day study period. The study is expected to begin immediately, and will be performed by Topstone Research in Toronto.
Antibe’s CEO Daniel Legault, commented: "We are pleased with the approval, and excited to begin this GI-safety trial. It is the key trial that we have been building towards for the past few years.
"Our aim is to demonstrate a substantial, statistically significant reduction of upper GI ulceration with ATB-346 as compared to that with naproxen. This remains the major safety issue with this very large class of drugs.
"I am also pleased that we remain on the timelines that we have previously announced." It is anticipated that the study will be completed in early 2018.