Phathom Unveils Promising VOQUEZNA Data On GERD Relief At The American College Of Gastroenterology Annual Meeting

Phathom Pharmaceuticals, Inc., a biopharma company dedicated to advancing and commercializing new treatments for gastrointestinal (GI) disorders, today declared that it will present data from several studies on its innovative treatment, VOQUEZNA® (vonoprazan) tablets, at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting, running from October 25-30 in Philadelphia, PA. 

VOQUEZNA is a unique potassium-competitive acid blocker (PCAB), and the only one approved by the FDA is currently indicated for the management of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (GERD). It helps in treating Erosive GERD across various severities and as part of a combination therapy for H. pylori infection eradication.

The VOQUEZNA treatment from the PHALCON-NERD-201 trial will be orally presented on October 28 by Dr. 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 principal investigator of the trial. 

This Phase 2 study, recognized with the ACG Outstanding Research Award, investigated the efficacy of VOQUEZNA for on-demand dosing in patients with non-erosive GERD. The post-hoc analysis revealed that VOQUEZNA, at doses of 10 mg, 20 mg, and 40 mg, provided faster and longer-lasting heartburn relief compared to a placebo. Specifically, the study results revealed that symptom improvement was noted with VOQUEZNA at one hour and sustained as long as 24 hours with all doses. As VOQUEZNA is not yet FDA-approved for the as-needed use in Non-Erosive GERD, these results indicate how flexible dosing could be beneficial.

Ronnie Fass, M.D., said, “As a healthcare provider, the concept of a novel 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. 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, extended As Needed study period.”

The practical application of As Needed dosing for VOQUEZNA would be understood through this new analysis, daily heartburn symptom burden at baseline while patients are receiving daily VOQUEZNA, and post-switching to As Needed treatment once the patient reaches symptom control during the run-in period. 

The analysis aimed to provide insights into the viability of as-needed dosing for managing episodic heartburn after initial symptom control with daily VOQUEZNA use. In this randomized, placebo-controlled Phase 2 study, 207 participants received 20 mg of VOQUEZNA daily for four weeks. Patients who achieved heartburn control at the end of the treatment period were randomized to receive either one of three doses of VOQUEZNA or a placebo for six weeks of as-needed treatment.