Phathom Pharmaceuticals presented new data on VOQUEZNA® (vonoprazan) at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting, showcasing its potential in treating Non-Erosive Gastroesophageal Reflux Disease (GERD). The presentations included findings on on-demand dosing efficacy and the relief of nocturnal GERD symptoms.
On-Demand VOQUEZNA for Non-Erosive GERD
Dr. Ronnie Fass presented results from a post-hoc analysis of the Phase 2 PHALCON-NERD-201 trial, which evaluated the efficacy of as-needed VOQUEZNA for episodic heartburn relief in Non-Erosive GERD patients. The study, recognized with the ACG Outstanding Research Award, followed a 4-week daily VOQUEZNA run-in period. The analysis examined daily heartburn symptom burden at baseline, during daily treatment, and after switching to as-needed treatment.
The results indicated that patients eligible for the on-demand period (n=207) experienced a significant increase in heartburn-free days during the run-in period (mean of 82.9% [95% CI: 80.4%, 85.4%]) compared to screening (mean of 16.1% [95% CI: 13.5%, 18.7%]). This improvement was sustained throughout the six-week on-demand period (means 71% to 75%). Furthermore, the difference in improvement of treated heartburn episodes between the active and placebo groups was evident within the first hour of dosing (10 mg [75.5%, p<0.0001], 20 mg [69.1%, p = 0.0010], 40 mg [75.5%, p<0.0001], placebo [57.0%]). Over 90% of heartburn episodes treated with VOQUEZNA improved within two hours.
Dr. Fass noted, "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."
Relief of Nocturnal GERD Symptoms
Dr. Catiele Antunes presented data on nocturnal symptoms in Non-Erosive GERD patients. The study included an exploratory analysis of the Nocturnal Gastro-esophageal reflux disease Symptom Severity and Impact Questionnaire (N-GSSIQ) to determine the severity, morning impact, and concern about nocturnal GERD.
The results showed that after 4 weeks, the least-square (LS) mean percentage of heartburn-free nights was significantly better with VOQUEZNA 10 mg (59.9%, LS mean difference=16.5%, p<0.0001 vs. placebo) and 20 mg (56.4%, LS mean difference=13.1%, p<0.0001 vs. placebo), compared to placebo (43.3%). N-GSSIQ scores also showed significant improvement with VOQUEZNA compared to placebo in total score (p<0.005), nocturnal symptom severity (p<0.001), and concern about nocturnal GERD (p<0.0001).
Eckhard Leifke, M.D., Chief Medical Officer at Phathom, stated, "In our study, patients who experienced nocturnal GERD symptoms prior to VOQUEZNA treatment found effective and meaningful relief with daily dosing, reinforcing its potent and durable acid suppression profile in helping to address both daytime and nighttime heartburn."
About VOQUEZNA
VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) approved in the U.S. for the treatment of Erosive Esophagitis, relief of heartburn associated with Erosive GERD, relief of heartburn associated with Non-Erosive GERD, and for the treatment of H. pylori infection in combination with antibiotics.
