Wednesday, August 07, 2019 8:20:44 AM
From CEO letter
“Phase 2B Dose-Ranging, Efficacy Study Remains on Track
Our Phase 2B dose-ranging, efficacy study for ATB-346 remains on track for a top-line data read-out this summer; the study is well underway with all 35 clinical sites actively enrolling patients. The study is designed to validate the effectiveness of ATB-346 in reducing osteoarthritis (“OA”) pain and establish the lowest effective dose. Specifically, the study includes three doses of ATB-346 that will be individually assessed for superiority versus placebo. With a total of 360 patients, the study powers both the high dose (250 mg) and middle dose (200 mg) for statistical significance which will provide more robust efficacy data that can be leveraged as we engage global partners. Importantly, this is the final Phase 2 study for ATB-346 and represents a major development milestone and inflection point for Antibe if one of the doses meets the primary endpoint.”
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