PHAT - Phathom Pharma gains on Phase 3 results for heartburn therapy

Phathom Pharmaceuticals ( NASDAQ: PHAT ), a biopharma focused on GIT disorders, traded higher on Monday after the company said a Phase 3 trial for its experimental heartburn therapy vonoprazan met the primary endpoint.

Vonoprazan is designed to block acid secretion in the stomach. The 776-patient PHALCON-NERD-301 evaluated its effectiveness as a daily treatment for adults with symptomatic non-erosive gastroesophageal reflux disease (sGERD or NERD).

According to the company, the topline data from the four-week trial indicated that vonoprazan at both 10 mg and 20 mg doses met the main goal of PHALCON-NERD-301, showing a “significantly greater percentage of 24-hour heartburn-free days versus placebo.”

PHALCON-NERD-301 also demonstrated 48.3%, 46.7%, and 17.0% as the median percentage of 24-hour heartburn-free days for vonoprazan 10 mg and 20 mg doses and placebo, respectively.

A 20-week long-term extension period of the trial is currently underway to evaluate the safety and efficacy of vonoprazan at 10 mg and 20 mg doses following six months of continuous use.

“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,” Phathom ( PHAT ) Chief Executive Terrie Curran said.

“Today’s results mark Phathom’s third positive Phase 3 trial for vonoprazan across three different indications,” she added.

In 2021, Phathom ( PHAT ) said a Phase 3 trial for the candidate met its primary non-inferiority endpoints in erosive esophagitis.

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