FLORHAM PARK, NJ, October 23, 2022 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. FATa biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders, today announced that it has received detailed results from a phase 2 exploratory study evaluating the efficacy of vonoprazan in non-erosive gastroesophageal reflux disease ( NERD) and additional data will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting 2022, being held October 21-26 in Charlotte, NC.
PHALCON NERD On Demand
In an oral plenary session during the ACG, Ronnie Fass, MD, director of the Division of Gastroenterology and Hepatology and Medical Director of the Digestive Health Center at MetroHealth in Cleveland, Ohio, and principal investigator of the PHALCON-NERD study. This presentation is the first publication of secondary and exploratory endpoint analyzes since Phathom published topline data from the study in February 2022.
The double-blind, placebo-controlled PHALCON-NERD study randomized 207 patients to be eligible for treatment as needed (“as needed”) after a 4-week daily lead-in period in which patients received 20 mg of vonoprazan once daily. Patients without heartburn in the last seven days of the run-in period were equally randomized to receive 10 mg, 20 mg, or 40 mg of vonoprazan or placebo for six weeks.
Key results include:
- The primary endpoint was met for all three doses of vonoprazan, resulting in complete and sustained relief in 56% (10 mg), 60.6% (20 mg), and 70% (40 mg) of heartburn episodes within three hours without additional heartburn was reported for 24 hours in the on-demand period compared to placebo (27.3%, p<0.0001).
- In exploratory endpoints, the onset of complete and sustained relief from heartburn is…
