Phathom Pharmaceuticals Announces Completion of Patient Enrollment in Pivotal Phase 3 Helicobacter pylori (H. pylori) Trial
Topline results expected in second quarter of 2021
- NDA submission for H. pylori expected in second half of 2021
FLORHAM PARK, N.J., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today 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.
“The completion of patient enrollment in the PHALCON-HP trial marks another significant milestone for Phathom and for the millions of people with H. pylori infection. In the U.S. and Europe, one-in-three adults are believed to carry H. pylori, which, if left untreated, can lead to dyspeptic symptoms, ulcers, and gastric cancer. These regions are experiencing declining H. pylori eradication rates due to increasing antibiotic resistance which we believe can be addressed with more potent inhibition of gastric acid. Our ability to enroll patients in the PHALCON-HP trial during a pandemic highlights the demand for new therapeutic regimens to combat this chronic bacterial infection,” said Azmi Nabulsi, M.D., Phathom’s Chief Operating Officer. “Phathom greatly appreciates the commitment and execution of our investigators and clinicians involved in PHALCON-HP and thanks all our patient volunteers for their participation.”