PHAT - Phathom posts positive results from late-stage vonoprazan combo study

Phathom Pharmaceuticals (PHAT) announces that both vonoprazan-based regimens in its pivotal Phase 3 clinical trial for the eradication of H. pylori infection successfully met their main and secondary goals.The trial studied vonoprazan in combination with amoxicillin and clarithromycin and in combination with amoxicillin compared to lansoprazole in combination with amoxicillin and clarithromycin.The primary endpoints in the study were non-inferiority of the H. pylori eradication rate for each of vonoprazan triple and dual therapy compared to lansoprazole triple therapy.In the modified intent-to-treat ((mITT)) population, H. pylori eradication rates were 84.7% with vonoprazan triple therapy and 78.5% for vonoprazan dual therapy compared to 78.8% with lansoprazole triple therapy (p<0.0001 and p=0.0037, respectively, for non-inferiority).H. pylori is a bacterial pathogen that is estimated to infect over 200M people in the United States and Europe.New Drug Application submissions for the treatment are targeted for Q4 2021.

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Phathom posts positive results from late-stage vonoprazan combo study