Company: PHAT
Filing Date: 2025-03-06
Form Type: 10-K
Source: 0000950170-25-034183
Chunk: 11

Company: Phathom Pharmaceuticals, Inc.
Filing Date: 2025-03-06
Form: 10-K
Item: Item 1
Chunk 11
---
 across indications, including EoE, and alternative formulations and packaging. We plan to pursue vonoprazan lifecycle extension strategies in areas with clear unmet need, clinical rationale, and commercial justification. For example, 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. Additionally, we believe that vonoprazan has the ideal profile for an OTC product because of the potential for rapid symptom relief and a well-tolerated safety profile. We plan to explore the economics and potential development in this market to determine the best strategy going forward. Potential indications for development in addition to EoE may include treatment of gastric and duodenal ulcers, and Barrett’s esophagus; and alternative formulations and packaging include orally disintegrating tablets and other oral dosage forms for patients with difficulty swallowing, and an intravenous formulation for in-hospital applications. We are also evaluating further development of vonoprazan as an “as needed” treatment of Non-Erosive GERD. With our recent launch of VOQUEZNA for Non-Erosive GERD, we have begun generating real-world data which are being reviewed to understand consumer usage patterns and prescribing habits of healthcare providers. These insights will help assess the value and potential timing for advancing a Phase 3 program to validate the "as needed" dosing of VOQUEZNA for active heartburn episodes. 

•Evaluate commercial partnerships to maximize the vonoprazan opportunity outside of the United States. To address the opportunity for vonoprazan in Europe and Canada, we continue to evaluate potential partners with existing commercial infrastructure and expertise in these markets. We believe this strategy could allow us to realize the value of the market opportunity in Europe and Canada while focusing our resources on the U.S. market.  

•In-license or acquisition of additional clinical or commercial stage product candidates for the treatment of GI diseases in a capital efficient manner. We plan to evaluate and to take advantage of our management team’s GI expertise to opportunistically in-license or acquire additional innovative therapies for diseases treated by gastroenterologists. We plan to leverage our development and commercial infrastructure to support multiple assets targeting GI indications. 

Acid-Related GI Diseases 

Overview 

Gastric acid is a digestive fluid formed in the stomach. The highly acidic environment of the stomach causes the unfolding, or denaturing, of food proteins that are subsequently broken