Phathom Pharmaceuticals Announces Completion of Patient Enrollment in Pivotal Phase 3 Erosive Esophagitis Trial

Nachrichtenquelle: globenewswire
30.11.2020, 22:05  |  111   |   |   

Topline results expected in second half of 2021

FLORHAM PARK, N.J., Nov. 30, 2020 (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-EE, the Company’s pivotal Phase 3 clinical trial of vonoprazan for both the healing and maintenance of healing of erosive esophagitis (EE) as well as the relief of heartburn. Phathom exceeded the patient enrollment target of 1,000 patients. Phathom continues to expect topline results from the PHALCON-EE trial in the second half of 2021.

PHALCON-EE is a randomized, double-blind, two-phase, multicenter Phase 3 trial that has enrolled over 1,000 patients with EE in the U.S. and Europe. The first phase of the trial is evaluating the efficacy and safety of vonoprazan 20 mg administered once-daily (QD) compared to lansoprazole 30 mg QD for the healing of EE for up to eight weeks. The second phase of the trial is evaluating the efficacy and safety of vonoprazan 10 mg QD and 20 mg QD compared to lansoprazole 15 mg QD for the maintenance of healing of EE for 24 weeks. Both phases will also evaluate relief of heartburn symptoms.

“Completing patient enrollment in PHALCON-EE is a significant milestone for Phathom in our mission to bring innovative treatments to the millions of people battling gastrointestinal diseases. Exceeding our enrollment targets and timelines in the midst of a global pandemic underscores the great unmet need existing for new treatment options for patients with erosive esophagitis and further supports our belief that vonoprazan has the potential to transform the EE treatment paradigm,” said Azmi Nabulsi, M.D., Phathom’s Chief Operating Officer. “We are thankful for the unwavering commitment, support, and enthusiasm of the investigators and clinicians involved in executing this trial and are incredibly grateful to the patients who volunteered to participate in PHALCON-EE. We eagerly look forward to topline results from this trial in the second half of next year.”

PHALCON-EE is one of two Phase 3 trials evaluating vonoprazan in gastrointestinal diseases. The second trial, PHALCON-HP, is a randomized, multicenter trial evaluating vonoprazan in combination with antibiotics for the successful eradication of H. pylori infection. Phathom expects to complete patient enrollment in PHALCON-HP in the first quarter of 2021 with topline results expected in the second quarter of 2021.

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Phathom Pharmaceuticals Announces Completion of Patient Enrollment in Pivotal Phase 3 Erosive Esophagitis Trial Topline results expected in second half of 2021FLORHAM PARK, N.J., Nov. 30, 2020 (GLOBE NEWSWIRE) - Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel …

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