Phantom Pharmaceuticals Inc. (NASDAQ: PHAT) has announced positive findings from PHALCON-NERD, a second phase trial assessing three vonoprazan dose levels (40mg, 20mg, and 10mg) as in-demand treatment of episodic heartburn relief in people with non-erosive gastroesophageal reflux disease (NERD).
Vonoprazan dose levels attained primary outcomes
All three vonoprazan dosage levels achieved the primary outcome in this double-blind, placebo-controlled trial and were statistically meaningful (p0.0001) relative to placebo.
The primary outcome was the proportion of heartburn episodes eased completely within 3 hours (“complete relief”) and lasted for more than 24 hours (“sustained relief”). For example, compared to 27.3 percent of assessable heartburn episodes1, vonoprazan 10 mg, 20 mg, and 40 mg provided complete and persistent relief in 56.0 percent, 60.6 percent, and 70.0 percent assessable heartburn episodes, respectively, within 3 hours.
The open-label everyday dose run-in phase of the PHALCON-NERD experiment included all patients receiving vonoprazan 20 mg/ day for four weeks. During this time, the average percentage of twenty-four-hour heartburn-free days was 65.4 percent (median 76.0 percent ).
COO Azmi Nabulsi said, “We believe the data from this Phase 2 study are very encouraging for the treatment of NERD, a highly prevalent gastroesophageal disease which often presents itself with episodic heartburn. These results support the potential of vonoprazan to transform the treatment of patients with NERD by offering much needed flexibility in the management of their NERD heartburn symptoms via preventative daily dosing or on-demand dosing.”
Vonoprazan well tolerated
In the trial, vonoprazan was safe and well-tolerated. During both stages of the study, no more than 3% of subjects in each treatment group experienced an adverse event. There were 4 serious adverse events (SAEs) in the daily dosage period but none in the on-demand phase. The safety results for all vonoprazan cohorts were similar to placebo and in line with previous research findings.
Phathom has stated that it has started NERD-301, a Phase 3 study assessing vonoprazan 10 mg and 20 mg as daily dosing therapy for NERD treatment, based on these promising results.
