Company: PHAT
Filing Date: 2025-03-06
Form Type: 10-K
Source: 0000950170-25-034183
Chunk: 2

Company: Phathom Pharmaceuticals, Inc.
Filing Date: 2025-03-06
Form: 10-K
Item: Item 1
Chunk 2
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, see the discussion in our risk factors related to non-patent regulatory exclusivity. 

While we are initially focused on the commercialization of vonoprazan for the treatment of GERD and H. pylori infection, we believe there are opportunities to develop vonoprazan in other indications in our licensed territories. For example, we plan to expand the clinical development of vonoprazan in the U.S. into eosinophilic esophagitis, or EoE, the most common type of eosinophilic gastrointestinal disease. EoE is an autoimmune disease with significant unmet need and can result in trouble swallowing, chest pain, vomiting and impaction of food in the esophagus, a medical emergency. There are only two FDA-approved treatments for EoE. Although not approved for this indication, PPIs are often prescribed as a first-line therapy for the treatment of EoE. Given the limited choices of therapies for EoE and vonoprazan’s demonstrated potential, we believe EoE is an important indication for future study. We have obtained FDA feedback on the design of a Phase 2 study investigating VOQUEZNA as a potential treatment for EoE, in adults and adolescents, and plan to initiate the study in the first half of 2025.

GERD and H. pylori infection are two of the most common acid-related GI diseases and impact millions of people. The prevalence of GERD is estimated to be 20% of the U.S. population and 15% of the population in the five major countries in Europe (France, Germany, Italy, Spain and the United Kingdom), or collectively, the EU5. GERD is a disease that develops when the reflux of acidic stomach contents causes troublesome symptoms and/or complications. An estimated 20 million adults in the U.S. have Erosive GERD and more than twice that number, or an estimated 45 million adults, are believed to suffer from Non-Erosive GERD. H. pylori is a bacterial pathogen that infects approximately 35% of the U.S. population and 45% of the EU5 population. As a result of the chronic inflammation induced by H. pylori infection, approximately 20% of infected patients will develop a range of pathologies, including dyspepsia, peptic ulcer disease, gastric cancer, and mucosa-associated lymphoid tissue or MALT, lymphoma.  

Over the last thirty years, the proton pump inhibitor, or