FLORHAM PARK - 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.
About pHalcon-EoE-201
pHalcon-EoE-201 (NCT06851559) is a Phase 2, randomized, double-blind, placebo-controlled study evaluating VOQUEZNA (vonoprazan) 20 mg in approximately 80 adults with eosinophilic esophagitis (EoE) across approximately 40 U.S. sites. In Part 1, participants with endoscopically-confirmed EoE and dysphagia will receive once-daily VOQUEZNA or placebo for 12 weeks. Those who complete Part 1 may enter Part 2, a 12-week extension period, during which all patients will receive VOQUEZNA 20 mg once daily.
About Eosinophilic Esophagitis
Eosinophilic esophagitis (EoE) is a chronic, immune condition of the esophagus where white blood cells called eosinophils build up in the lining, causing inflammation and potential difficulty or painful swallowing, choking or food impaction. Additional symptoms may also include chest pain, heartburn, regurgitation, and vomiting. Although the exact cause is unknown, it is believed to be triggered by a variety of stimuli including certain foods and environmental allergens. Identifying EoE can be complex and delayed diagnosis is common among patients. If left untreated, the inflammation of EoE can worsen and narrow the esophagus, further exacerbating symptoms.
About VOQUEZNA
VOQUEZNA (vonoprazan) tablets contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB). PCABs are a novel class of medicines that block acid secretion in the stomach. VOQUEZNA is approved in the U.S. for the treatment of adults with Erosive Esophagitis, also known as Erosive GERD, the relief of heartburn associated with Erosive GERD, the relief of heartburn associated with Non-Erosive GERD, and for the treatment of H. pylori infection in combination with either amoxicillin or amoxicillin and clarithromycin. Phathom in-licensed the rights to vonoprazan for the U.S., Europe and Canada from Takeda, which markets the product in Japan and numerous other countries in Asia and Latin America.
About Phathom Pharmaceuticals, Inc.
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB), for the U.S., Europe and Canada. Phathom currently markets vonoprazan in the United States as VOQUEZNA (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, and as part of VOQUEZNA TRIPLE PAK (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA DUAL PAK (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding: our plans, expectations, and goals for development of VOQUEZNA in eosinophilic esophagitis (EoE); potential timelines for the pHalcon-EoE-201 study (the 'Study'), including timelines for reporting of topline results; the potential for the Study to support discussions on a pediatric program that could extend regulatory exclusivity; the unmet need for additional options in the treatment of EoE and the potential of VOQUEZNA as a treatment option and our plans, expectations and strategies with respect to our business, goals, mission and vision and as to future performance, results and likelihood of success, are forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplates,' 'believes,' 'estimates,' 'predicts,' 'potential', 'guidance', or 'continue' or the negative of these terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including the risk that: we may encounter issues with conduct of the Study that delay our timelines, including slower than expected enrollment or issues with conduct of the study or data analysis; we may receive negative or mixed results from the Study that are not sufficient to advance the program; even if the results of the Study are positive, we may decide not to advance the EoE program and we may decide not to conduct a pediatric program in EoE; if we decide to conduct a pediatric program in EoE, the studies we conduct may not meet the requirements or timelines for receiving an extension of our regulatory exclusivity for VOQUEZNA; the data from the Study or any future studies we may conduct in EoE may not support the potential for VOQUEZNA as a treatment option in this indication; the success of the EoE program may be impacted by potential safety or tolerability issues, competition from other therapies or treatment approaches, or technical issues; future cash needs may cause us to change our plans and any of the foregoing or other factors may negatively impact our ability to achieve our plans, goals, mission, vision and potential. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Nick Benedetto
Tel: 1-877-742-8466
Email: media@phathompharma.com
Eric Sciorilli
Tel: 1-877-742-8466
Email: ir@phathompharma.com
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