Company: PHAT
Filing Date: 2025-03-06
Form Type: 10-K
Source: 0000950170-25-034183
Chunk: 27

Company: Phathom Pharmaceuticals, Inc.
Filing Date: 2025-03-06
Form: 10-K
Item: Item 1
Chunk 27
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 mg administered as needed for relief of episodic heartburn compared to placebo in subjects with Non-Erosive GERD (as confirmed by endoscopy). After an initial four-week vonoprazan 20 mg QD dose open-label run-in period, two hundred and seven subjects without a heartburn episode during the last 7 days of the run-in period and who also met drug and diary compliance requirements were randomized to receive vonoprazan 10 mg, 20 mg, 40 mg or placebo as needed for six weeks. Subjects completed an electronic diary to assess presence and severity of heartburn symptoms and use of rescue antacid (if needed). 

In this Phase 2 proof-of-concept trial, the primary endpoint was the percentage of heartburn episodes completely relieved within three hours and with no further heartburn reported for 24 hours after taking study drug. All three vonoprazan doses met this primary endpoint and were statistically significant (p<0.0001) when compared to placebo. Within three hours, vonoprazan 10 mg, 20 mg and 40 mg achieved complete and sustained relief in 56.0%, 60.6% and 70.0% of evaluable heartburn episodes, respectively, as compared to 27.3% of episodes for placebo.

During the PHALCON-NERD open-label daily dosing run-in phase, where all enrolled participants received vonoprazan 20 mg QD for four weeks, the mean percentage of 24-hour heartburn free days observed was 65.4% (median 76.0%).

With our recent launch of VOQUEZNA for Non-Erosive GERD, we have begun generating real-world data which is being reviewed to understand consumer usage patterns and prescribing habits of healthcare providers. We believe these efforts will help assess the value and potential timing for advancing a Phase 3 program to evaluate the as needed dosing of VOQUEZNA for active heartburn episodes, building on the positive results from our prior Phase 2 study.

21

Results of Phase 2 Non-Erosive GERD As Needed Dosing Trial

Vonoprazan in Combination with Antibiotics for the Treatment of H. pylori Infection 

Disease Burden and Outcomes 

H. pylori is a bacterial pathogen that infects approximately 35% of the U.S. population, 45% of the EU5 population, and more than 50% of the global population. We estimate that there