Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical
company focused on developing and commercializing novel treatments
for gastrointestinal (GI) diseases, today announced the submission
of an NDA to the FDA for vonoprazan as a daily treatment for
Non-Erosive gastroesophageal reflux disease (GERD) in adults. The
regulatory submission is supported by the positive data from the
PHALCON-NERD-301 study, a Phase 3 study evaluating the efficacy and
safety of vonoprazan for the daily treatment of adults with
Non-Erosive GERD (NERD). Vonoprazan is an investigational
first-in-class potassium-competitive acid blocker (PCAB) from a
novel class of medicines that block acid secretion in the stomach.
“The submission of the NERD daily dosing NDA represents a major
potential advancement for the estimated 38 million adults in the
U.S. suffering from the symptoms of Non-Erosive GERD, many of whom
are dissatisfied with currently available therapies,” said Terrie
Curran, President and Chief Executive Officer at Phathom. “Our NDA
is supported by the results of our successfully completed
PHALCON-NERD-301 study, which demonstrated vonoprazan’s durable
24-hour heartburn control over six months and reaffirmed its known
safety profile.”
The effectiveness and safety of vonoprazan 10 mg and 20 mg given
once daily in NERD was evaluated in a randomized,
placebo-controlled, double-blind, 4-week trial with a 20-week
blinded extension conducted in the United States in 772 adult
patients. As previously reported, both vonoprazan doses met the
primary endpoint for the mean percentage of heartburn free days
over the 4-week placebo-controlled period at 45%, 44%, and 28% for
vonoprazan 10 mg, vonoprazan 20 mg and placebo, respectively
(p<0.0001 for both doses).
Patients randomized to vonoprazan 10 mg and 20 mg during the
initial 4-week period remained on their blinded treatment
assignment for the 20-week extension period. The mean percentage of
heartburn free days reported over the 20-week extension period for
these patients was 63% for vonoprazan 10 mg and 61% for vonoprazan
20 mg.
Additionally, patients who were randomized to placebo during the
initial 4-week period were re-randomized to either vonoprazan 10 mg
or 20 mg for the 20-week extension period. For these patients, the
mean percentage of heartburn free days reported over the 20-week
extension period was 62% for vonoprazan 10 mg and 63% for
vonoprazan 20 mg.
As previously reported, the overall adverse events were
comparable between vonoprazan and placebo during the 4-week
placebo-controlled period of which the most common events were
nausea, abdominal pain, constipation, and diarrhea, reported at or
below 3% for either vonoprazan 10 mg or 20 mg doses. The most
common adverse events reported for the two vonoprazan
doses during the 20-week extension period were upper
respiratory tract infection, sinusitis, influenza, urinary tract
infection, nasopharyngitis, nausea, and gastroenteritis, reported
at or below 5%.
Phathom expects a 10-month regulatory review and if approved,
anticipates a third quarter 2024 U.S. launch for vonoprazan as a
daily treatment for Non-Erosive GERD.
Phathom also plans to initiate an additional Phase 3 study to
evaluate vonoprazan as an As Needed treatment for episodic
heartburn relief in adults with Non-Erosive GERD, a novel dosing
treatment regimen.
“While our Non-Erosive daily dosing NDA is under review, we plan
to initiate a separate Phase 3 trial studying the As Needed dosing
of vonoprazan for active heartburn episodes, a dosing regimen for
which proton pump inhibitors (PPIs) are not approved in the U.S.,
thereby representing a significant unmet need,” said Azmi Nabulsi,
M.D., Chief Operating Officer at Phathom. “We look forward to
confirming the positive results from our previous Phase 2 As Needed
study of vonoprazan in Non-Erosive GERD and, if our Phase 3 study
is successful, vonoprazan has the potential to offer a new
treatment option for Non-Erosive GERD patients with flexibility to
be taken either daily, or for heartburn symptoms that require rapid
and sustained relief, on an as-needed basis.”
Vonoprazan is under active review by the FDA as a treatment of
Erosive GERD and relief of heartburn associated with Erosive GERD
in adults, with a Prescription Drug User Fee Act (PDUFA) goal date
of November 17, 2023. If approved, a commercial launch is planned
for the fourth quarter of 2023.
About Non-Erosive Gastroesophageal Reflux
DiseaseNon-Erosive GERD is the largest subcategory of
gastroesophageal reflux disease (GERD) and is characterized by
reflux-related symptoms in the absence of esophageal mucosal
erosions. There are an estimated 38 million U.S. adults living with
Non-Erosive GERD, of these approximately 15 million are treated
with a prescription medicine annually. Symptoms of NERD impact
overall quality of life and can include episodic heartburn,
especially at night, regurgitation, problems swallowing, and chest
pain.
About Phathom PharmaceuticalsPhathom
Pharmaceuticals is a biopharmaceutical company focused on the
development and commercialization of novel treatments for
gastrointestinal diseases. Phathom has in-licensed the exclusive
rights in the United States, Europe, and Canada to vonoprazan, a
first-in-class potassium-competitive acid blocker (PCAB). For more
information about Phathom, visit the Company’s website
at www.phathompharma.com and follow the
Company on LinkedIn and Twitter.Forward
Looking StatementsThis press release contains
forward-looking statements. Investors are cautioned not to place
undue reliance on these forward-looking statements, including
statements about the potential of vonoprazan as a treatment for
Non-Erosive GERD; the timing of potential approval of the
Non-Erosive GERD NDA; the timing of initiating the additional Phase
3 clinical trial to evaluate vonoprazan as an as-needed treatment
for episodic heartburn relief in patients with Non-Erosive
GERD, and statements regarding the PDUFA goal date and the
timing of a U.S. commercial launch for the Erosive GERD and H.
pylori indications. 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 press release due to the risks and
uncertainties inherent in Phathom’s business, including, without
limitation: the FDA may refuse to file the NDA for Non-Erosive
GERD; Phathom may delay or choose not to initiate the planned
Phase 3 trial to evaluate vonoprazan as an as-needed treatment for
Non-Erosive GERD; future data generated from our stability program
may be different from the data submitted to the FDA to date and may
not demonstrate that our mitigation efforts will continue to
maintain the level of the nitrosamine impurity below the acceptable
intake (AI) level throughout the shelf life of the products, if
approved, which could result in market action or shelf life
reduction; risks associated with product manufacturing or
formulation changes required to be made in connection with
achieving the AI; the FDA may disagree that the existing safety and
efficacy data, together with additional data, is sufficient to
approve the Erosive GERD NDA or supplements to the H.
pylori NDAs; the inherent risks of clinical development of
vonoprazan; Phathom’s dependence on third parties in connection
with product manufacturing, research and preclinical and clinical
testing; regulatory developments in the United States and foreign
countries; unexpected adverse side effects or inadequate efficacy
of vonoprazan that may limit its development, regulatory approval
and/or commercialization, or may result in recalls or product
liability claims; Phathom’s ability to access additional capital
under its term loan facility and royalty interest finance
agreements is subject to certain conditions; Phathom’s ability to
obtain and maintain intellectual property protection for
vonoprazan; Phathom’s ability to comply with its license agreement
with Takeda; and other risks described in the Company’s prior press
releases and the Company’s filings with the Securities and Exchange
Commission (SEC), including under the heading “Risk Factors” in the
Company’s Annual Report on Form 10-K and any subsequent filings
with the SEC. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof, and Phathom 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.
MEDIA CONTACTNick
Benedetto1-877-742-8466media@phathompharma.com
INVESTOR CONTACTEric
Sciorilli1-877-742-8466ir@phathompharma.com
© 2023 Phathom Pharmaceuticals. All rights reserved.
Phathom Pharmaceuticals (NASDAQ:PHAT)
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Phathom Pharmaceuticals (NASDAQ:PHAT)
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