Phathom Pharmaceuticals presented new data on VOQUEZNA® (vonoprazan) at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting, showcasing the drug's potential in treating gastroesophageal reflux disease (GERD). The presentations highlighted VOQUEZNA's efficacy in both on-demand and daily dosing regimens for Non-Erosive GERD, as well as its impact on nocturnal GERD symptoms.
On-Demand VOQUEZNA for Non-Erosive GERD
Ronnie Fass, M.D., presented findings from a post-hoc analysis of the Phase 2 PHALCON-NERD-201 trial, which evaluated the efficacy of on-demand VOQUEZNA compared to placebo for episodic heartburn relief in patients with Non-Erosive GERD. The study included a 4-week daily VOQUEZNA run-in period. The analysis, recognized with the ACG Outstanding Research Award, demonstrated that all VOQUEZNA doses (10 mg, 20 mg, and 40 mg) resulted in higher percentages of heartburn completely relieved within three hours and sustained for 24 hours, with significant differences observed as early as one hour (p<0.0001 for 10mg and 40mg, p=0.0010 for 20mg compared to placebo).
The analysis examined daily heartburn symptom burden at baseline, during daily VOQUEZNA treatment, and after switching to on-demand treatment. Results showed 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 maintained throughout the six-week on-demand period (means 71% to 75%).
Impact on Nocturnal GERD Symptoms
Catiele Antunes, M.D., presented data on the impact of VOQUEZNA on nocturnal GERD symptoms in Non-Erosive GERD patients. The study, which received ACG’s Presidential Poster Award, included an exploratory analysis of the Nocturnal Gastro-esophageal reflux disease Symptom Severity and Impact Questionnaire (N-GSSIQ).
The results indicated that VOQUEZNA significantly improved nocturnal symptoms. 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 for both VOQUEZNA 10 mg and 20 mg), nocturnal symptom severity (p<0.001 for both VOQUEZNA 10 mg and 20 mg), and concern about nocturnal GERD (p<0.0001 for both VOQUEZNA 10 mg and 20 mg).
Clinical Implications
These findings suggest that VOQUEZNA offers a valuable treatment option for GERD patients, addressing both daytime and nighttime symptoms. The on-demand dosing regimen provides flexibility for patients experiencing episodic heartburn, while the improvement in nocturnal symptoms enhances overall quality of life. Eckhard Leifke, M.D., Chief Medical Officer at Phathom, stated, "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."
