Phathom Starts Phase 3 Trial of Vonoprazan in Non-Erosive Gastroesophageal Reflux Disease

 

• A total of 776 patients with symptomatic NERD have been enrolled and randomized in the multisite trial across the U.S.
   
• Topline data for the primary endpoint is expected in Q1 2023 with full trial results available in late-2023
   
• NERD is the largest subcategory of gastroesophageal reflux disease (GERD) and affects an estimated 45 million people in the U.S.

FLORHAM PARK, N.J., Oct. 24, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, today announced it has completed enrollment in its PHALCON-NERD Daily Dosing Phase 3 trial of vonoprazan in non-erosive gastroesophageal reflux disease (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 Company expects to share topline data from the primary endpoint in the first quarter of 2023 and full results from the study in late 2023.

If successful, Phathom believes that the trial will form the basis of a supplemental New Drug Application (sNDA) for vonoprazan as once daily therapy for the treatment of symptomatic NERD in adults in 2023.

NERD is the largest subcategory of gastroesophageal reflux disease (GERD) and is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions. There are estimated to be over 65 million individuals with GERD in the U.S., and it is estimated that seventy percent (70%) of this population have NERD.

The primary endpoint of the double-blind Phase 3 PHALCON-NERD-301 study is evaluating the efficacy of vonoprazan 10 mg and 20 mg as a daily dosing (QD) treatment, as compared to placebo (QD), in the relief of heartburn over four weeks in participants with symptomatic NERD. The trial also includes a unique blinded 20-week long-term extension period to further evaluate the safety and efficacy of both doses of vonoprazan after six months.

https://www.biospace.com/article/releases/phathom-pharmaceuticals-completes-patient-enrollment-in-phase-3-phalcon-nerd-301-daily-dosing-trial-of-vonoprazan-in-non-erosive-gastroesophageal-reflux-disease-nerd-/