Phathom Pharmaceuticals Announces Vonoprazan NDA Submission for Non-Erosive GERD

• Submission based on positive results from Phase 3 PHALCON-NERD-301 in which vonoprazan 10 mg and 20 mg controlled heartburn symptoms through the entire 6 months of the study with a safety profile consistent with prior vonoprazan studies
• New drug application (NDA) seeks U.S. Food and Drug Administration (FDA) approval for vonoprazan as a daily treatment for Non-Erosive GERD, the largest subcategory of GERD with an estimated U.S. adult population of 38 million
• FDA action date for Non-Erosive GERD NDA expected in the third quarter of 2024

FLORHAM PARK, N.J., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced the submission of an NDA to the FDA for vonoprazan as a daily treatment for Non-Erosive gastroesophageal reflux disease (GERD) in adults. The regulatory submission is supported by the positive data from the PHALCON-NERD-301 study, a Phase 3 study evaluating the efficacy and safety of vonoprazan for the daily treatment of adults with Non-Erosive GERD (NERD). Vonoprazan is an investigational first-in-class potassium-competitive acid blocker (PCAB) from a novel class of medicines that block acid secretion in the stomach.

“The submission of the NERD daily dosing NDA represents a major potential advancement for the estimated 38 million adults in the U.S. suffering from the symptoms of Non-Erosive GERD, many of whom are dissatisfied with currently available therapies,” said Terrie Curran, President and Chief Executive Officer at Phathom. “Our NDA is supported by the results of our successfully completed PHALCON-NERD-301 study, which demonstrated vonoprazan’s durable 24-hour heartburn control over six months and reaffirmed its known safety profile.”

The effectiveness and safety of vonoprazan 10 mg and 20 mg given once daily in NERD was evaluated in a randomized, placebo-controlled, double-blind, 4-week trial with a 20-week blinded extension conducted in the United States in 772 adult patients. As previously reported, both vonoprazan doses met the primary endpoint for the mean percentage of heartburn free days over the 4-week placebo-controlled period at 45%, 44%, and 28% for vonoprazan 10 mg, vonoprazan 20 mg and placebo, respectively (p