Phathom Pharmaceuticals Presents New VOQUEZNA® Data for GERD Treatment at ACG 2024
核心洞察
Phathom Pharmaceuticals presented data on VOQUEZNA® (vonoprazan) at the ACG 2024 meeting, highlighting its efficacy in treating GERD.
A post-hoc analysis of the PHALCON-NERD-201 trial showed that on-demand VOQUEZNA provided rapid relief of heartburn in Non-Erosive GERD patients.
Data from another study indicated VOQUEZNA significantly improved nocturnal GERD symptoms, offering better sleep quality for patients.
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 (搜索) (GERD). The presentations included findings from studies evaluating on-demand dosing for Non-Erosive GERD and the impact on nocturnal GERD symptoms.
On-Demand VOQUEZNA for Non-Erosive GERD
Ronnie Fass, M.D., director of the Division of Gastroenterology and Hepatology at MetroHealth in Cleveland, Ohio, presented results from a post-hoc analysis of the Phase 2 PHALCON-NERD-201 trial. The study, which received the ACG Outstanding Research Award in the ‘Esophagus’ category, assessed the efficacy of on-demand VOQUEZNA compared to placebo for episodic heartburn relief in patients with Non-Erosive GERD, following a 4-week daily dosing period.
The analysis focused on daily heartburn symptom burden at baseline, during daily VOQUEZNA treatment, and after switching to on-demand treatment. Key findings included:
- Patients eligible for the on-demand period (n=207) initially reported a mean of 16.1% [95% CI: (13.5%, 18.7%)] heartburn-free days during screening, which increased to 82.9% [95% CI: (80.4%, 85.4%)] during the daily run-in period.
- Heartburn-free days remained significantly above pre-treatment levels (71% to 75%) throughout the six-week on-demand period.
- Improvement in treated heartburn episodes was evident within the first hour of dosing, with significant differences between active and placebo groups (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."
Impact on Nocturnal GERD Symptoms
Another presentation by Dr. Catiele Antunes from Yale New Haven Hospital highlighted the impact of VOQUEZNA on nocturnal GERD symptoms in Non-Erosive GERD patients. This study, which received ACG’s Presidential Poster Award, analyzed data from a validated patient-reported outcomes scale, the Nocturnal Gastro-esophageal reflux disease Symptom Severity and Impact Questionnaire (N-GSSIQ).
Key results included:
- The mean percentage of heartburn-free nights during the screening period was 29.6%, 25.8% and 31.1% for patients randomized to placebo, VOQUEZNA 10 mg and 20 mg, respectively.
- After 4 weeks, the least-square (LS) mean percentage of heartburn-free nights significantly improved 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 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."
These findings suggest that VOQUEZNA could offer a significant benefit for patients experiencing nocturnal GERD symptoms, potentially improving their overall quality of life.
About VOQUEZNA
VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) approved in the U.S. for treating Erosive Esophagitis (搜索), relieving heartburn associated with Erosive GERD and Non-Erosive GERD, and treating H. pylori infection in combination with antibiotics. It is marketed exclusively by Phathom Pharmaceuticals.