• First patient dosed, with topline results expected in 2027
• pHalcon-EoE-201 is the first large, well-controlled clinical trial of an acid secretory treatment in EoE

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced the first patient has been dosed in its Phase 2 pHalcon-EoE-201 clinical trial evaluating VOQUEZNA^® (vonoprazan) tablets as an investigational treatment for eosinophilic esophagitis (EoE) in adults.

“The initiation of the pHalcon-EoE-201 study reflects Phathom’s commitment to advancing care for patients with gastrointestinal diseases and our development strategy to expand VOQUEZNA’s clinical potential,” said Steve Basta, President and Chief Executive Officer at Phathom. “This trial represents an important opportunity to address significant unmet needs in the treatment of EoE while potentially generating data to support discussions on a pediatric program that could ultimately extend VOQUEZNA’s regulatory exclusivity and strengthen our long-term growth strategy as leaders in GI.”

“Despite advances in understanding eosinophilic esophagitis, treatment options remain limited, with only two approved therapies currently available,” said Evan S. Dellon, MD, MPH, Professor of Medicine in the Division of Gastroenterology and Hepatology, and Director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, Chapel Hill, and principal investigator of the pHalcon-EoE-201 study. “Proton pump inhibitors (PPIs) are traditionally used as first-line treatment for EoE, but none are FDA approved for this indication, and supporting data come primarily from uncontrolled studies. VOQUEZNA’s acid suppression profile could potentially offer an oral, non-steroidal treatment approach for patients with EoE.”

Phathom’s Phase 2 EoE study is a two-part, randomized, double-blind, placebo-controlled study. The first part will enroll 80 adults with endoscopic-confirmed EoE and dysphagia, or trouble swallowing, to be randomized evenly to receive VOQUEZNA 20 mg or placebo, once daily for 12 weeks. Patients who complete the initial 12-week treatment period will be eligible to enter Part 2, a 12-week extension phase, where all subjects will receive VOQUEZNA 20 mg for the remainder of the study.

Topline primary and secondary results are anticipated to be available in 2027.