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Phathom Pharmaceuticals Announces Positive Topline Results from PHALCON-EE Pivotal Phase 3 Erosive Esophagitis Trial
Vonoprazan met its primary non-inferiority endpoints in both healing and maintenance phasesVonoprazan demonstrated superior healing rates in patients with
About this update from Phathom Pharmaceuticals, Inc.
[{"type":"text","content":"Vonoprazan met its primary non-inferiority endpoints in both healing and maintenance phasesVonoprazan demonstrated superior healing rates in patients with moderate-to-severe disease at Week 2 versus lansoprazole (PREVACID®), a proton pump inhibitor (PPI)Vonoprazan demonstrated superior maintenance of healing in all patients and patients with moderate-to-severe disease versus lansoprazole at Week 24New Drug Application (NDA) submission planned for H1 2022 targeting the following indications: healing of all grades of erosive esophagitis (EE) and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn Phathom to host conference call today, October 18, 2021, at 8:30 am ET FLORHAM PARK, N.J., Oct. 18, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that vonoprazan successfully met its primary endpoints and key secondary superiority endpoints in PHALCON-EE, a pivotal phase 3 trial evaluating vonoprazan versus lansoprazole for the treatment of erosive esophagitis. Based on the positive PHALCON-EE data, Phathom plans to submit an NDA to the U.S. Food and Drug Administration seeking the following indications: healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn. “The PHALCON-EE results are a major milestone for Phathom and for the 20 million Americans suffering from erosive esophagitis. The results further solidify vonoprazan’s potential to be the first major innovation in the U.S. and European GERD market in more than 30 years,” said Terrie Curran, Phathom’s President and Chief Executive Officer. “The results demonstrated that vonoprazan is superior to a standard of care PPI across a broad range of clinically relevant endpoints in the study, importantly including the maintenance of healing erosions at 24 weeks for all EE patients. We are excited about the potential for vonoprazan to satisfy the large unmet needs of so many patients and set a new treatment paradigm in EE. We thank the patients, physicians, and clinical sites who participated in the PHALCON-EE study during the height of the COVID-19 pandemic, and we look forward to submitting an NDA and, if ap...