Company: PHAT
Filing Date: 2025-03-06
Form Type: 10-K
Source: 0000950170-25-034183
Chunk: 24

Company: Phathom Pharmaceuticals, Inc.
Filing Date: 2025-03-06
Form: 10-K
Item: Item 1
Chunk 24
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Healing and Maintenance of Healing of Erosive GERD Clinical Trials in Japan and Asia 

The results of PHALCON-EE were consistent with the results of earlier Phase 3 trials of vonoprazan in healing and maintenance of healing of Erosive GERD after which it was modeled. These trials were conducted in Japan as well as other countries in Asia.  

In two Phase 3 trials in healing of Erosive GERD comparing vonoprazan 20 mg QD to lansoprazole 30 mg QD for up to eight weeks, one conducted in Japan and the other in several countries in Asia, vonoprazan achieved the primary endpoint of non-inferiority versus lansoprazole on the percent of patients with healed Erosive GERD up to Week 8. Exploratory testing suggested higher healing rates for vonoprazan versus lansoprazole in the moderate to severe patients at Week 2 in both studies.

Similarly, in two Phase 3 trials in maintenance of healing of Erosive GERD comparing two doses of vonoprazan (10 mg and 20 mg QD) to lansoprazole 15 mg QD for 24 weeks, one conducted in Japan and the other in several countries in Asia, both vonoprazan doses achieved the primary endpoint of non-inferiority versus lansoprazole on the percent of patients with recurrence of Erosive GERD during the 24-week maintenance period. In both studies, exploratory testing suggested higher maintenance of healing rates for both vonoprazan doses versus lansoprazole in all patients and in the moderate to severe patients.

Our Development Program in Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD)  

 In July 2024, the FDA approved VOQUEZNA for the relief of heartburn associated with Non-Erosive GERD, the largest category of GERD. Non-Erosive GERD patients do not have esophageal erosions that require chronic treatment to prevent recurrence of erosions and their potential sequelae. Moreover, we believe the rapid onset of acid control of vonoprazan may enable as-needed use for the management of heartburn in Non-Erosive GERD patients as an alternative to chronic daily treatment.

Daily Dosing of Vonoprazan for the Treatment of Heartburn Associated with Non-Erosive GERD (PHALCON-NERD-301)