Antibe Therapeutics has reported positive results from a Phase IIb gastrointestinal (GI) safety study of ATB-346, after the trial met its primary endpoint.
The double-blind trial enrolled 244 healthy subjects and was conducted to determine the superiority of ATB-346 in GI safety compared to naproxen, a commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) in the US.
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In the trial, subjects were given either 250mg of ATB-346 once-daily or 500mg of naproxen twice-daily.
At the end of the two-week treatment period, subjects on ATB-346 reportedly expressed an ulceration rate of 2.5% against an ulceration rate of 42.1% for subjects on naproxen, with a very high degree of statistical significance.
ATB-346 was also found to be safe and well tolerated during the trial, which was conducted in Toronto, Canada.
The trial’s primary endpoint was the incidence of gastric or duodenal ulcers of at least 3mm diameter with unequivocal depth, considered the gold standard in assessing the GI safety of NSAIDs.
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By GlobalDataAntibe Therapeutics chief scientific officer John Wallace said: “The number of subjects that developed ulcers while on treatment with ATB-346 was 3 (out of 118), compared to 53 (out of 126) for subjects treated with naproxen.
“This result was achieved with an impressive level of statistical significance. In addition, the incidence of elevated liver transaminases in the ATB-346 group was consistent with our expectations and the incidence associated with commonly-prescribed NSAIDs.”
Antibe plans to release a detailed summary of the clinical trial results, including secondary endpoints, by the second quarter of this year.
The company also noted that it will conduct a placebo-controlled dose ranging and effectiveness study of ATB-346, with a data read-out planned in the last quarter of the year.
