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Phathom Pharmaceuticals Announces Initiation of Pivotal Phase 3 Clinical Trial for Vonoprazan in Helicobacter Pylori (H. pylori) Infection
BUFFALO GROVE, Ill.--(BUSINESS WIRE)-- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing
About this update from Phathom Pharmaceuticals, Inc.
[{"type":"text","content":" BUFFALO GROVE, Ill.--(BUSINESS WIRE)--\nPhathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today the initiation of PHALCON-HP. In this pivotal Phase 3 clinical trial, clinicians will evaluate vonoprazan in combination with amoxicillin (vonoprazan dual therapy) and vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) for the successful eradication of H. pylori infection. With the initiation of PHALCON-HP, vonoprazan is now being evaluated in two pivotal trials to support regulatory submissions in two different disease areas in the United States and Europe. Earlier this month, the company initiated PHALCON-EE, a pivotal trial evaluating vonoprazan for both the healing and maintenance of healing of erosive esophagitis as well as the relief of heartburn. Topline data from both PHALCON-HP and PHALCON-EE are expected in 2021.\n\n\nPHALCON-HP is a randomized, multicenter, Phase 3 trial that is planned to enroll approximately 975 patients with H. pylori infection. Participants will be randomized 1:1:1 to one of three arms: vonoprazan 20 mg administered twice a day (BID) and amoxicillin 1g administered three times a day (TID); vonoprazan 20 mg BID, amoxicillin 1 g BID and clarithromycin 500 mg BID; and lansoprazole 30 mg BID, amoxicillin 1 g BID and clarithromycin 500 mg BID. Each treatment regimen will be administered for 14 days. The primary endpoint of PHALCON-HP is the percentage of patients with successful eradication of H. pylori infection.\n\n\n“The initiation of the PHALCON-HP study is another significant step in the development of vonoprazan for underserved patients living with gastrointestinal diseases,” said Azmi Nabulsi, MD, Chief Operating Officer of Phathom. “There are millions of people living with H. pylori infection in the United States and Europe and due to increased antibiotic resistance, eradication rates for patients treated with currently available therapies are declining. In addition to the troubling symptoms of H. pylori infection, H. pylori patients have an increased risk of developing other serious diseases including gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. Vonoprazan, if approved, represents a first-in-cl...