Antibe Therapeutics Announces Positive Top-Line Data From Phase 2B Dose-Ranging, Efficacy Study For ATB-346
- ATB-346 demonstrates superiority to placebo in reducing osteoarthritis pain -
- ATB-346 is more potent than expected; lowest effective dose still to be established -
- Antibe plans pivotal Phase 2/3 adaptive registration trial -
Antibe Therapeutics Inc. (TSXV: ATE, OTCQB: ATBPF) is pleased to announce that its lead drug, ATB-346, met the primary endpoint in the Phase 2B dose-ranging, efficacy study. Both the 250 mg and 200 mg doses of ATB-346 demonstrated superiority to placebo in reducing osteoarthritis (“OA”) pain with a high level of statistical significance. The 150 mg dose of ATB-346, although not powered for statistical significance, demonstrated more potency than expected and the lowest effective dose is still to be established. The drug was safe and well tolerated during this study. The Company is planning a pivotal Phase 2/3 randomized, controlled trial with an adaptive design that will define the lower end of the dose-response curve.
“We are pleased that our drug provided excellent pain relief to the patients in the study,” remarked Dan Legault, Antibe’s CEO. “The success of this study is a worthy complement to the GI safety results already in hand. With the extensive learning that these Phase 2 studies have provided, we have a clear path forward including an opportunity to lower the dose further. Through an adaptive registration trial we can maintain our clinical and commercial timelines, and focus on large market partnering.”
A total of 385 patients with osteoarthritis (OA) of the knee were randomized to either placebo or ATB-346 administered once daily: 250 mg, 200 mg or 150 mg. The primary endpoint in the study was the change from baseline in the WOMAC pain subscale score as measured at the end of the 14-day treatment period. The 250 mg and 200 mg doses were powered for statistical significance and the 150 mg dose was powered to only observe an efficacy response.
ATB-346 demonstrated superiority to placebo at doses of 250 mg (p-value of 0.01) and 200 mg (p-value of 0.007). Similar efficacy was observed between these doses, suggesting that the upper range of the dose-response curve has been reached. The 150 mg dose demonstrated a robust efficacy response and had it been equivalently powered to the other treatment arms, the Company believes it would have achieved statistical significance. As such, the lower portion of the dose-response curve remains to be established.