Phathom Pharmaceuticals has reported positive topline data from the Phase III PHALCON-NERD-301 trial of vonoprazan to treat symptomatic non-erosive gastroesophageal reflux disease (sGERD or NERD).
The double-blind, placebo-controlled Phase III trial was designed for assessing vonoprazan’s safety and efficacy for the daily treatment of sGERD or NERD adult patients.
Its primary endpoint was to evaluate the efficacy of 10mg and 20mg of vonoprazan given over four weeks as a daily dosing (QD) treatment for heartburn relief in symptomatic NERD patients.
The findings demonstrated that both of the vonoprazan doses met the primary endpoint and also showed a significantly high percentage of 24-hour heartburn-free days, compared to a placebo.
The median percentage of 24-hour heartburn-free days was 48.3% for vonoprazan 10mg, 46.7% for 20mg, and 17.0% for the placebo.
Phathom president and CEO Terrie Curran said: “Today’s results mark Phathom’s third positive Phase III trial for vonoprazan across three different indications.
“The topline data are expected to form the basis of our FDA submission seeking approval of vonoprazan as a daily treatment for patients with NERD, following completion of the long-term extension portion of the trial.
“These data are very encouraging for the treatment of NERD, a highly prevalent category of gastroesophageal reflux disease that causes disruptive day and nighttime symptoms for over 45 million patients in the US.”
The company stated that the Phase III trial also includes a blinded, 20-week long-term extension period that is currently ongoing for further assessing the efficacy and safety of both doses of vonoprazan following six months of continuous treatment.
For the multisite US trial, 776 symptomatic NERD patients were enrolled and randomised.
Phathom said that the data is expected to provide the basis for future regulatory submission for vonoprazan as a daily treatment for NERD patients.
The complete data from the trial is anticipated later this year.