PHAT - Phathom announces positive topline data from late-stage trial on H. pylori infection

Phathom Pharmaceuticals (PHAT) has announced that its pivotal Phase 3 clinical trial for the eradication of H. pylori infection with vonoprazan-based regimens has reached the primary endpoints and met all secondary endpoints.The trial named PHALCON-HP was designed to evaluate vonoprazan + amoxicillin and clarithromycin (vonoprazan triple therapy) and vonoprazan + amoxicillin (vonoprazan dual therapy) against lansoprazole + amoxicillin and clarithromycin (lansoprazole triple therapy).It involved 992 patients with confirmed H. pylori infection.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 vs 78.8% with lansoprazole triple therapy (p<0.0001 and p=0.0037, respectively, for non-inferiority).In all patients and patients with clarithromycin resistant strains of H. pylori., the two regimens have met all secondary endpoints, the company said.Vonoprazan-based treatment combinations were well tolerated with a safety profile comparable to lansoprazole triple therapy.“There are estimated to be over 200 million people infected with

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Phathom announces positive topline data from late-stage trial on H. pylori infection