Phathom Pharmaceuticals, Inc. Announces Completion of Patient Enrollment in Pivotal Phase 3 Helicobacter pylori (H. pylori) Trial
January 19, 2021 at 08:30 am EST
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Phathom Pharmaceuticals, Inc. announced that it has completed patient enrollment in PHALCON-HP, a pivotal Phase 3 clinical trial of vonoprazan in combination with amoxicillin (vonoprazan dual therapy) and vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) for the eradication of H. pylori infection. Phathom continues to expect topline results from the study in the second quarter of 2021. PHALCON-HP is a randomized, multicenter, Phase 3 trial that has enrolled over 1,000 patients with H. pylori infection. Participants are evenly randomized 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 1g BID and clarithromycin 500 mg BID; and lansoprazole 30 mg BID, amoxicillin 1g BID and clarithromycin 500 mg BID. Each treatment regimen is administered for 14 days. The primary endpoint is the percentage of patients with successful eradication of H. pylori infection. PHALCON-HP is one of two Phase 3 trials evaluating vonoprazan in gastrointestinal diseases. The second trial, PHALCON-EE, is a randomized, double-blind, two-phase, multicenter trial evaluating vonoprazan in the treatment of erosive esophagitis (EE). Patient enrollment in PHALCON-EE was completed in November 2020 with topline results expected in the second half of 2021.
Phathom Pharmaceuticals, Inc. is a biopharmaceutical company. The Company is focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases. The Companyâs pipeline product candidate, VOQUEZNA, VOQUEZNA TRIPLE PAK, and VOQUEZNA DUAL PAK. Its product candidate, VOQUEZNA, contains vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB). PCABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan has also demonstrated clinical benefits in the treatment of erosive gastroesophageal reflux disease (erosive GERD), and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection. GERD and H. pylori infection are two of the most common acid-related GI diseases. GERD is a disease that develops when the reflux of acidic stomach contents causes troublesome symptoms and/or complications. H. pylori is a bacterial pathogen.