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Phathom Pharmaceuticals Reports Second Quarter 2021 Results and Provides Update Regarding Key Clinical and Regulatory Milestones
Pivotal Phase 3 PHALCON-EE trial topline data for vonoprazan in erosive esophagitis expected in October 2021Phase 2 PHALCON-NERD on-demand trial for
About this update from Phathom Pharmaceuticals, Inc.
[{"type":"text","content":"Pivotal Phase 3 PHALCON-EE trial topline data for vonoprazan in erosive esophagitis expected in October 2021Phase 2 PHALCON-NERD on-demand trial for vonoprazan in non-erosive reflux disease enrolling ahead of schedule with topline data now expected in the first quarter of 2022 FLORHAM PARK, N.J., Aug. 10, 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 reported financial results for the second quarter of 2021 and provided an update on expected clinical and regulatory milestones. “Our execution against key priorities through the second quarter has advanced several critical catalysts which we expect will lay the foundation for Phathom’s long-term success,” said Terrie Curran, Phathom’s President and Chief Executive Officer. “We continue to progress our GERD development programs, which have the potential to address the unmet needs in a population of approximately 65 million people in the U.S. We are expecting topline data from our pivotal Phase 3 PHALCON-EE trial evaluating vonoprazan for erosive esophagitis (EE) in October 2021 and are now expecting topline data from our Phase 2 PHALCON-NERD trial evaluating vonoprazan as an on-demand treatment for non-erosive reflux disease (NERD) in Q1 2022. Additionally, we are nearing the submission of new drug applications (NDAs) to the FDA for both the dual and triple vonoprazan-based regimens for the treatment of H. pylori infection, now expected in September 2021. The anticipated progress over the next several months will be key to advancing our mission of changing the landscape in gastrointestinal diseases.” Clinical Development and Regulatory Timing Updates: Phathom has accelerated its work on the NDAs for dual and triple vonoprazan-based regimens for the treatment of H. pylori infection and now expects to submit both NDAs in September 2021 instead of in the fourth quarter of 2021.Topline results from PHALCON-EE, a pivotal Phase 3 trial evaluating vonoprazan for the healing and maintenance of erosive esophagitis, are expected in October 2021.Topline results from the PHALCON-NERD on-demand Phase 2 trial evaluating various doses of vonoprazan as an on-demand therapy for patients with non-erosive reflux disease are expected in...