Antibe Therapeutics announced its Phase 2B dose-ranging, efficacy study for ATB-346 has formally commenced. Enrollment is open, clinical sites have been activated and patients will now begin screening.
The study is designed to validate the efficacy of ATB-346 in reducing osteoarthritis (OA) pain and establish the dose for Phase 3 development. The study will involve a total of 360 patients with OA of the knee, who will be randomized to placebo or one of three doses of ATB-346 administered once daily: 150 mg, 200 mg or 250 mg.
“We are excited to officially commence the final Phase 2 study for ATB-346,” said Dan Legault, Antibe’s CEO. “A successful outcome in this large clinical trial will further validate the best-in-class potential of ATB-346, and will represent a major inflection point as we position ourselves for Phase 3 development and global partnering discussions.”
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The study is being conducted by Veristat in approximately 35 clinical sites across Canada and is expected to have a top-line data read-out this summer.
ATB-346 is a hydrogen sulfide-releasing derivative of naproxen. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most commonly used therapy for osteoarthritis, but their use is associated with a high incidence of gastrointestinal ulceration and bleeding. NSAIDs are also widely used in conditions such as rheumatoid arthritis, ankylosing spondylitis, gout, and general pain reduction, with a similarly high rate of gastrointestinal ulceration and bleeding. It is well-accepted that patients with these conditions would benefit greatly from an effective, non-addictive, GI-sparing anti-inflammatory/analgesic agent such as ATB-346.