Antibe Therapeutics Inc (CVE:ATE) (OTCQB:ATBPF) has unveiled positive results from its Phase 2B clinical trial of flagship drug ATB-346, which was better than the placebo in reducing osteoarthritis (OA) pain.
The drug met the primary endpoint in the dose-ranging, efficacy study, which involved 385 patients, the biotech firm said.
Antibe is now planning another pivotal Phase 2/3 randomized, controlled trial to define the lowest effective dose of the drug.
"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," Dan Legault, Antibe’s chief executive said in a statement.
"Through an adaptive registration trial we can maintain our clinical and commercial timelines, and focus on large market partnering.”
ATB-346 is being developed to work as an alternative to nonsteroidal anti-inflammatory drugs, or NSAIDs. The drug is a naproxen-derivative that has been shown to deliver pain relief with significantly less gastrointestinal (GI) damage typical NSAID usage.
Both the 250 mg and 200 mg doses of the drug showed superiority to placebo in reducing pain with a high level of statistical significance.
Significantly, the 150 mg dose, although not powered for statistical significance, demonstrated more potency than expected and the lowest effective dose is still to be established, said Antibe.
The next Phase 2/3 efficacy trial will compare multiple doses of ATB-346 to placebo in OA patients over 12 weeks.
Antibe said it intends to submit this study to the US FDA as a formal registration trial.
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