Item 8.01 Other Events.
On
The topline results from the four-week, double-blind, placebo-controlled period showed both doses of vonoprazan 20 mg and 10 mg met the primary endpoint and demonstrated a significantly greater percentage of 24-hour heartburn-free days versus placebo (mean 46.4% vonoprazan 10 mg, 46.0% vonoprazan 20 mg, compared to 27.5% for placebo; p<0.0001 for both vonoprazan 10 mg and 20 mg versus placebo). The median percentage of 24-hour heartburn-free days was 48.3%, 46.7% and 17.0% for vonoprazan 10 mg, vonoprazan 20 mg, and placebo, respectively.
The primary endpoint of the double-blind Phase 3 PHALCON-NERD-301 study
evaluated the efficacy of vonoprazan 10 mg and 20 mg as a daily dosing (QD)
treatment, as compared to placebo (QD), in the relief of heartburn over four
weeks in participants with sGERD. The trial also includes a blinded 20-week
long-term extension period, which is currently ongoing, to further evaluate the
safety and efficacy of both doses of vonoprazan after six months of continuous
use. A total of 776 patients with symptomatic NERD were enrolled and randomized
in the multisite
Vonoprazan was generally well tolerated in the initial four week double-blind, placebo-controlled phase of the trial. The overall adverse events for all vonoprazan arms were comparable to placebo and consistent with what was reported in previous studies. The most commonly reported adverse event was nausea (2.3% vonoprazan 10 mg, 3.1% vonoprazan 20 mg, 0.4% placebo) with no other events reported above 3.0% in either vonoprazan dose arm.
Phathom is currently in discussions with the FDA on the design of a separate
Phase 3 trial to evaluate the novel dosing regimen for vonoprazan as an
on-demand or "as needed" treatment for episodic heartburn relief in patients
with NERD, a dosing treatment regimen not approved in the
Forward Looking Statements
Phathom cautions you that statements contained in this report regarding matters
that are not historical facts are forward-looking statements. These statements
are based on the Company's current beliefs and expectations. Such
forward-looking statements include, but are not limited to, statements regarding
the expected timing of full trial results from NERD-301, NERD-301 data providing
the basis for submission of a marketing application to FDA and the potential of
vonoprazan as a treatment for patients with symptomatic NERD. The inclusion of
forward-looking statements should not be regarded as a representation by Phathom
that any of its plans will be achieved. Actual results may differ from those set
forth in this report due to the risks and uncertainties inherent in Phathom's
business, including, without limitation: reported top-line data is based on
preliminary analysis of key efficacy and safety data, which is subject to
completion of the NERD-301 trial and additional audit and verification
procedures that could result in material changes in the final data; FDA actions
related to Phathom's
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undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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