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FLORHAM PARK, N.J., May 24, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that results from multiple studies evaluating the efficacy of vonoprazan were presented at Digestive Disease Week® (DDW) 2022, being held May 21-24 in person in San Diego, CA and virtually.
PHALCON-EE StudyIn an oral presentation session, results from the PHALCON-EE study, an investigational Phase 3 registration trial evaluating vonoprazan compared to the proton pump inhibitor (PPI) lansoprazole in patients with erosive esophagitis (EE), will be shared by Loren Laine, M.D., Professor of Medicine, and Chief, Digestive Diseases at Yale School of Medicine, and lead investigator of the PHALCON-EE study.
Results of PHALCON-EE showed that vonoprazan, a novel potassium-competitive acid blocker (PCAB), demonstrated non-inferiority to the PPI lansoprazole in complete healing by week 8, the study’s primary endpoint, and showed superiority in a prespecified, exploratory analysis.1 In addition, vonoprazan demonstrated superior healing at week 2 in patients with Los Angeles (LA) Grade C/D EE and superior maintenance of healing in all patients with EE versus lansoprazole.1 Patients with this classification are typically more difficult to treat and current available treatments may not provide complete resolution of esophageal erosions. The LA Classification categorizes EE from Grades A through D based on disease severity.4
“These data provide further insights from the PHALCON-EE study for the novel PCAB vonoprazan in a Western patient population, which had not been assessed previously,” said Stuart J. Spechler, M.D., AGAF, FACG, co-director of the Center for Esophageal Diseases at Baylor University Medical Center in Dallas, Texas. “A significant proportion of patients with EE do not have complete resolution of erosion in the esophageal tissue with PPI therapy. The study’s results demonstrate the potential of this new treatment class for all patients with EE and are particularly impressive in those with moderate-to-severe disease, who are at risk for serious complications if left untreated.”
PHALCON-EE evaluated 1,024 Helicobacter pylori (H. pylori)-negative adults in the U.S. and Europe with EE who were randomized to receive vonoprazan 20 mg or lansoprazole 30 mg for up to eight weeks. The study’s primary endpoints were percent healed by week 8 in the healing phase, and percent who maintained healing at week 24 in the maintenance phase.1
“As the first head-to-head study of vonoprazan versus a traditional PPI therapy in Western patients, PHALCON-EE provides important confirmation about the potential of the PCAB treatment class for gastroenterologists and their patients,” said Azmi Nabulsi, M.D., Chief Operating Officer at Phathom. “Phathom recently submitted its new drug application in the U.S. for vonoprazan in EE based on the strength of the results from PHALCON-EE, and we’re optimistic that vonoprazan has the potential to be an important treatment option in the future for GERD patients.”
PK/PD StudyDuring the meeting, Dr. Laine also presented a poster on a Phase 1 study evaluating the pharmacodynamics (PD) and pharmacokinetics (PK) of vonoprazan and the PPI lansoprazole in 44 healthy U.S. subjects, which was selected as a Poster of Distinction by the American Gastroenterological Association (AGA) Institute. The primary PD endpoint was the mean 24-hour holding-time ratio for pH>4 (pH>4 HTR) on day 7. Other PD parameters included 24-hour HTR for pH>4 on day 1 and 24-hour mean intragastric pH on days 1 and 7.
