Phathom Pharma's Digestive Disease Candidate Meets Primary Goal In Mid-Stage Study

Phathom Pharmaceuticals Inc PHAT reported topline results from the PHALCON-NERD Phase 2 study of vonoprazan as an on-demand therapy to relieve episodic heartburn in non-erosive gastroesophageal reflux disease (NERD). 

• All three vonoprazan dose levels met the primary endpoint and were statistically significant compared to placebo in the study.
• Within three hours, vonoprazan 10 mg, 20 mg, and 40 mg achieved complete and sustained relief in 56.0%, 60.6%, and 70.0% of evaluable heartburn episodes, respectively, compared to 27.3% on placebo.
• Related: Phathom's Vonoprazan Non-Inferior To Proton Pump Inhibitor For Esophagitis Inflammation.
• The PHALCON-NERD trial also included an open-label daily dosing run-in phase where all participants enrolled received vonoprazan 20 mg once daily (QD) for four weeks.
• Over this period, the mean percentage of 24-hour heartburn-free days observed was 65.4% (median 76.0%).
• Phathom has initiated NERD-301 Phase 3 for vonoprazan 10 mg and 20 mg as daily dosing (QD) therapy for NERD. 
• The Company expects to report topline results from NERD-301 in 2023. 
• Price Action: PHAT shares traded 3.50% higher at $17.91 on the last check Thursday.