First patient dosed, with topline results expected in 2027pHalcon-EoE-201 is the first large, well-controlled clinical trial of an acid secretory treatment in EoE FLORHAM PARK, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced the first patient has been dosed in its Phase 2 pHalcon-EoE-201 clinical trial evaluating VOQUEZNA® (vonopraza ...

Core Insights - Phathom Pharmaceuticals announced the publication of additional analyses from its pivotal Phase 3 pHalcon-NERD-301 trial for VOQUEZNA (vonoprazan) in treating Non-Erosive Reflux Disease (NERD), highlighting its potential to alleviate nighttime GERD symptoms [1][8] Group 1: Clinical Findings - Nighttime GERD symptoms affect up to 80% of patients, leading to impaired sleep and increased health risks, yet many patients do not find relief with existing treatments [2][9] - The Phase 3 trial involved 772 patients, randomized to receive either VOQUEZNA (10 mg or 20 mg) or placebo, with significant findings on symptom relief [3][5] - VOQUEZNA demonstrated rapid and sustained relief of nighttime GERD symptoms, with heartburn-free nights increasing significantly after the first dose and maintained through 24 weeks [5][6] Group 2: Efficacy Data - At week 4, patients on VOQUEZNA 10 mg and 20 mg reported heartburn-free nights of 59.9% and 56.4%, respectively, compared to 43.3% for placebo [6] - Improvements in nocturnal symptom severity and sleep-related impacts were sustained throughout the treatment period, with median heartburn-free nights remaining above 70% [5][6] - VOQUEZNA was generally well tolerated, with common adverse events being mild and occurring in less than 5% of patients [6][7] Group 3: Product Information - VOQUEZNA is a potassium-competitive acid blocker (PCAB) approved for treating Erosive and Non-Erosive GERD, as well as H. pylori infection [10][30] - Approximately 38 million U.S. adults suffer from Non-Erosive GERD, with around 15 million receiving prescription treatment annually [9]

Core Insights - Phathom Pharmaceuticals is participating in the ACG 2025 Annual Scientific Meeting to showcase its leadership in gastrointestinal treatments, particularly focusing on VOQUEZNA (vonoprazan) for GERD [1][2][3] Company Activities - The company will engage with the medical community through a product theater presentation on VOQUEZNA and will have a significant presence at the exhibit floor [2][3] - Phathom has organized an independent medical education program titled "Decision Points in the Management of GERD," scheduled for October 25, 2025 [5] Product Information - VOQUEZNA is a potassium-competitive acid blocker (PCAB) approved for treating various forms of GERD, including Erosive GERD and Non-Erosive GERD [6][25] - The product is marketed in the U.S. for multiple indications, including the relief of heartburn associated with Non-Erosive GERD and the healing of Erosive GERD [25] Safety and Efficacy - VOQUEZNA has been associated with several adverse reactions, including gastritis (3% in healing of Erosive GERD) and diarrhea (2% in relief of heartburn associated with Non-Erosive GERD) [20][21] - Important safety information includes contraindications for patients with hypersensitivity to vonoprazan and potential risks such as acute tubulointerstitial nephritis and Clostridioides difficile-associated diarrhea [6][10][11] Market Position - The company aims to build on the momentum for VOQUEZNA in the GERD treatment market by connecting with healthcare professionals and sharing clinical insights at the ACG meeting [3][25]

Core Insights - Phathom Pharmaceuticals is set to present real-world data on its first-in-class treatment VOQUEZNA (vonoprazan) for gastroesophageal reflux disease (GERD) at Digestive Disease Week (DDW) from May 3-6, 2025, in San Diego, CA [1][3] - VOQUEZNA is the only treatment approved by the U.S. FDA for adults for heartburn relief associated with Non-Erosive GERD and for treating all severities of Erosive Esophagitis (Erosive GERD) [1][34] - The data presented will analyze treatment patterns and patient characteristics, indicating VOQUEZNA's potential role for patients inadequately managed by existing therapies [3] Company Activities - Two Phathom-sponsored posters will be presented on May 5, 2025, at the conference, along with a Product Theater highlighting VOQUEZNA [2] - The company will maintain a strong presence at the conference with a booth (1743) on the exhibit floor [2] Industry Context - GERD affects approximately 1 in 5 U.S. adults, with around 70% of the GERD population suffering from Non-Erosive GERD [31][32] - Erosive GERD, affecting about 30% of the GERD population, can lead to severe complications if inadequately treated [33] - The conference will showcase over 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine, and technology [8]

Core Insights - Phathom Pharmaceuticals has partnered with Kenan Thompson to raise awareness about gastroesophageal reflux disease (GERD) through the "GERD IS NO JOKE" campaign, highlighting the importance of discussing treatment options with healthcare providers [1][7][10] Company Overview - Phathom Pharmaceuticals is focused on developing and commercializing innovative treatments for gastrointestinal diseases, specifically through its product VOQUEZNA (vonoprazan), which is the first FDA-approved potassium-competitive acid blocker (PCAB) for GERD management [23][20] - VOQUEZNA is approved for adults for the relief of heartburn associated with Non-Erosive GERD and for the treatment of Erosive Esophagitis, addressing a significant unmet need in the GERD patient population [20][18] Industry Context - Over 65 million people in the U.S. suffer from GERD, with approximately 70% having Non-Erosive GERD and 30% having Erosive GERD, indicating a large market potential for effective treatments [3][18] - The campaign aims to empower individuals with GERD to engage in open discussions with their healthcare providers about treatment options, particularly VOQUEZNA, which offers rapid and durable acid suppression compared to traditional medications [6][7]