Results
Phathom Pharmaceuticals Inc.
10/27/2025 | Press release | Distributed by Public on 10/27/2025 04:03
Material Event (Form 8-K)
| Item 8.01 |
Other Events. |
On October 25, 2025, Phathom Pharmaceuticals, Inc. ("Phathom" or the "Company") announced that results of additional analyses from its pivotal Phase 3 pHalcon-NERD-301trial evaluating VOQUEZNA® (vonoprazan) tablets in patients with Non-ErosiveReflux Disease ("NERD") have been published in the American Journal of Gastroenterology. The article, titled "VonoprazanImproves Nocturnal Gastroesophageal Reflux Symptoms in Non-ErosiveReflux Disease", underscores the significant burden of nighttime GERD symptoms and the potential role of VOQUEZNA in addressing this aspect of the disease.
Nighttime GERD symptoms are highly prevalent, affecting up to an estimated 80% of patients with GERD, and can be associated with impaired sleep, reduced work productivity, and increased risk of esophageal and respiratory complications. Despite lifestyle interventions and the widespread use of proton pump inhibitors ("PPIs") and H2-receptorantagonists ("H2Ras"), many patients experience inadequate relief of nocturnal symptoms, which remain underrepresented in clinical research.
In the Phase 3 pHalcon-NERD-301trial, 772 patients were randomized to VOQUEZNA 10 mg, 20 mg, or placebo for an initial 4-weekperiod. Patients on VOQUEZNA continued blinded active treatment for a 20-weekextension, while those on placebo were re-randomizedto VOQUEZNA 10 mg or 20 mg for the extension phase.
Key findings include:
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Percentage of Heartburn-Free Nights:At week 4, patients receiving VOQUEZNA 10 mg and 20 mg achieved mean percentages of heartburn-free nights of 59.9% and 56.4%, respectively, compared to 43.3% for placebo (nominal p<0.0001, exploratory analysis not adjusted for multiple comparisons). Median percentages of heartburn-free nights during the 4-weekplacebo-controlled treatment period were 70.4% for VOQUEZNA 10 mg, 71.0% for VOQUEZNA 20 mg, and 45.5% for placebo. |
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Onset of Effect:Separation from placebo was observed after the first dose, with 45.3% of VOQUEZNA 10 mg and 52.4% of VOQUEZNA 20 mg patients experiencing a heartburn-free night after the first dose vs. 32.1% on placebo. |
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Patient-Reported Outcomes:As measured by the validated Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire ("N-GSSIQ"),treatment with VOQUEZNA was associated with improvements from baseline versus placebo in total N-GSSIQscore, and in the subscales of nocturnal symptom severity and concern about nocturnal GERD, but not on morning impact. Improvements with VOQUEZNA were sustained through the 20-weekextension treatment period. |
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Durability:VOQUEZNA demonstrated sustained nocturnal symptom relief throughout the full treatment period, consistent with the 24-hourheartburn relief observed in the full pHalcon-NERD-301trial. Median heartburn-free nights remained above 70% across all treatment groups through the 20-weekactive extension. |
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Generally Well Tolerated: VOQUEZNA was generally well tolerated in both phases of the trial. The most common adverse events (≤3%) in the 4-weekperiod were nausea, abdominal pain, constipation, diarrhea, and urinary tract infection; in the 20-weekextension, most common adverse events (≤5%) included upper respiratory tract infection, sinusitis, influenza, urinary tract infection, nasopharyngitis, nausea, and gastroenteritis. |
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