FLORHAM PARK, N.J., Oct. 27, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced that the company will present data from multiple investigational studies for its first-in-class treatment VOQUEZNA® (vonoprazan) tablets at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting, being held October 25-30 in Philadelphia, PA. VOQUEZNA is approved for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD), for the treatment of all severities of Erosive Esophagitis, commonly referred to as Erosive GERD, and relief of related heartburn, and in combination with antibiotics for the eradication of Helicobacter pylori (H. pylori) infection.1 VOQUEZNA is the first and only U.S. Food and Drug Administration (FDA)-approved potassium-competitive acid blocker (PCAB).2
Evaluating On-Demand VOQUEZNA Treatment from the PHALCON-NERD-201 Trial3
In an oral presentation being presented Monday, October 28 at ACG, Ronnie Fass, M.D., director of the Division of Gastroenterology and Hepatology and medical director of the Digestive Health Center at MetroHealth in Cleveland, Ohio, and lead investigator of the PHALCON-NERD-201 trial, will provide results from a post-hoc analysis of the Phase 2 study. This research, recognized with the ACG Outstanding Research Award in the 'Esophagus' category, evaluated the efficacy of As Needed (On-Demand) dosing of VOQUEZNA, compared to placebo, for relief of episodic heartburn in participants with Non-Erosive GERD following a 4-week VOQUEZNA daily dosing "run-in” period. As previously reported, the primary analysis of the study demonstrated that all three VOQUEZNA doses tested (10 mg, 20 mg and 40 mg) had higher percentages of heartburn completely relieved within three hours of dosing and sustained for 24 hours, with significant differences reported as early as one hour. Use of As Needed dosing in this population is investigational as VOQUEZNA has been neither evaluated nor approved by the FDA as an As Needed treatment for Non-Erosive GERD.
To understand the practical application of As Needed dosing for VOQUEZNA, the new analysis examined daily heartburn symptom burden at baseline, during daily VOQUEZNA treatment, and upon switching to As Needed treatment after achieving symptom control during the run-in period. It also further evaluated the rate of symptom improvement upon treating new onset heartburn episodes during the As Needed dosing period.3
"As a healthcare provider, the concept of a novel As Needed dosing option for Non-Erosive GERD is highly compelling. I am pleased that ACG has recognized this data as a recipient of the ACG Outstanding Research Award, further reinforcing its importance to the GI community,” said Ronnie Fass, M.D. "The low frequency of heartburn after discontinuing daily VOQUEZNA treatment, coupled with the rapid onset of improvement following As Needed dosing, suggests that transitioning from daily dosing to As Needed treatment is a viable option for patients who previously respond well to daily therapy of VOQUEZNA. These promising results warrant further investigation in a larger and extended As Needed study period.”
The double-blind, placebo-controlled PHALCON-NERD Phase 2 study randomized 207 patients who were eligible for On-Demand ("As Needed”) treatment following a 4-week daily dosing run-in period in which patients received VOQUEZNA 20 mg once-daily. Patients without heartburn in the last seven days of the run-in period were evenly randomized to receive 10 mg, 20 mg or 40 mg of VOQUEZNA, or placebo, for six weeks. Results of the study were published in Alimentary Pharmacology & Therapeutics in September 2023.4
Results:3
Patients eligible for the On-Demand period (n=207) were highly symptomatic with a reported mean of 16.1% [95% CI: (13.5%, 18.7%)] heartburn-free days during screening. Heartburn-free days increased during the run-in period to a mean of 82.9% [95% CI: (80.4%, 85.4%)] and remained well above pre-treatment levels (means 71% to 75%) throughout the six-week On-Demand period.The difference in the improvement of treated heartburn episodes between the active and placebo groups became evident within the first hour of dosing (10 mg [75.5%, p Read The Rest at :
