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Phathom
Pharmaceuticals Completes Patient Enrollment in Phase 3 PHALCON-NERD-301 Daily Dosing Trial of
Vonoprazan
in
Non-Erosive Gastroesophageal Reflux Disease (NERD)
2022-10-24
·
BioSpace
合作
First in Class
A total of 776 patients with symptomatic NERD have been enrolled and randomized in the multisite trial across the U.S. Topline data for the primary endpoint is expected in Q1 2023 with full trial results available in late-2023 NERD is the largest subcategory of
gastroesophageal reflux disease (GERD)
and affects an estimated 45 million people in the U.S. FLORHAM PARK, N.J., Oct. 24, 2022 (GLOBE NEWSWIRE) --
Phathom Pharmaceuticals, Inc.
(Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for
gastrointestinal diseases and disorders
, today announced it has completed enrollment in its PHALCON-NERD Daily Dosing Phase 3 trial of
vonoprazan
in
non-erosive gastroesophageal reflux disease (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 Company expects to share topline data from the primary endpoint in the first quarter of 2023 and full results from the study in late 2023. If successful,
Phathom
believes that the trial will form the basis of a supplemental New Drug Application (sNDA) for
vonoprazan
as once daily therapy for the treatment of symptomatic NERD in adults in 2023. NERD 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 estimated to be over 65 million individuals with
GERD
in the U.S., and it is estimated that seventy percent (70%) of this population have NERD. The primary endpoint of the double-blind Phase 3 PHALCON-NERD-301 study is evaluating 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 symptomatic NERD. The trial also includes a unique blinded 20-week long-term extension period to further evaluate the safety and efficacy of both doses of
vonoprazan
after six months. “NERD is a highly prevalent
acid-related disorder
that impacts the overall quality of life of millions of people and can present painful and chronic symptoms including
episodic heartburn
and
chest pain
,” said Azmi Nabulsi, M.D., Chief Operating Officer at Phathom. “We are pleased to have marked another milestone with the completion of enrollment in our Phase 3 daily dosing trial of
vonoprazan
in NERD, bringing Phathom another step closer to provide a much-needed novel therapy for a disease that has not seen a new class of therapeutics introduced in the U.S. in over 30 years. We look forward to sharing the topline results in the first quarter of 2023.”
Phathom
is also currently in discussions with FDA on a second Phase 3 trial design to support 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 U.S. for
proton pump inhibitors (PPIs)
. About
Phathom Pharmaceuticals, Inc.
Phathom Pharmaceuticals
is a biopharmaceutical company focused on the development and commercialization of novel treatments for
gastrointestinal diseases and disorders
.
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).
Vonoprazan
-based regimens are approved in the U.S. as part of a co-packaged product in combination with antibiotics for the treatment of
H. pylori infection
in adults, marketed as VOQUEZNA™ TRIPLE PAK™ (
vonoprazan
,
amoxicillin
,
clarithromycin
) and
VOQUEZNA
™ DUAL PAK™ (
vonoprazan
,
amoxicillin
).
Phathom
has a New Drug Application under review by the FDA for
vonoprazan
in
erosive esophagitis (EE)
and is studying the use of
vonoprazan
for the treatment of
non-erosive reflux disease (NERD)
. For more information about
Phathom
, visit the Company’s website at and follow the Company on LinkedIn and Twitter. About
Non-Erosive Gastroesophageal Reflux Disease (NERD)
NERD is the largest subcategory of
gastroesophageal reflux disease (GERD)
and is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions.1,2 There are estimated to be over 65 million individuals with
GERD
in the U.S., and it is estimated that seventy percent (70%) of this population have NERD.2 Symptoms of NERD impact overall quality of life and can include
episodic heartburn
, especially at night, regurgitation, problems swallowing, and
chest pain.3,4
INDICATIONS AND USAGE VOQUEZNA™ TRIPLE PAK™ is a co-packaged product containing
vonoprazan
, a potassium-competitive acid blocker (PCAB),
amoxicillin
, a penicillin-class antibacterial, and
clarithromycin
, a macrolide antimicrobial.
VOQUEZNA
™ DUAL PAK™ is a co-packaged product containing
vonoprazan
and
amoxicillin
. Both products are indicated for the treatment of
Helicobacter pylori infection
in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, and other antibacterial drugs, both products should be used only to treat or prevent
infections
that are proven or strongly suspected of being caused by bacteria. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are contraindicated in patients with known
hypersensitivity
to
vonoprazan
or
amoxicillin
, any other components of the formulation, any other beta-lactams, or in patients receiving
rilpivirine
-containing products. Due to the
clarithromycin
component, VOQUEZNA TRIPLE PAK is also contraindicated in patients with any known
hypersensitivity
to
clarithromycin
or any
macrolide antibiotic
, in patients receiving
pimozide
,
lomitapide
,
lovastatin
,
simvastatin
,
ergotamine
,
dihydroergotamine
,
colchicine
in patients with
renal or hepatic impairment
, or those with a history of
cholestatic jaundice
/hepatic dysfunction. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious and occasionally fatal reactions (e.g.,
anaphylaxis
) have been reported with components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. If
hypersensitivity reactions
occur, discontinue use and institute immediate therapy (e.g.,
anaphylaxis
management). Severe Cutaneous Adverse Reactions (SCAR): Discontinue use of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK at first signs or symptoms of
SCAR
or other signs of
hypersensitivity
and consider further evaluation.
SCAR
, including
Stevens-Johnson syndrome (SJS)
and
toxic epidermal necrolysis (TEN)
have been reported with the components of both products. In addition, drug reaction with
eosinophilia
and
systemic symptoms (DRESS)
, and
acute generalized exanthematous pustulosis (AGEP)
have been reported with
amoxicillin
and
clarithromycin
.
Clostridioides difficile-associated diarrhea (CDAD)
: Evaluate if
diarrhea
occurs with VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK. CDAD has been reported with use of acid suppressing therapies and nearly all antibacterial agents, and may range in severity from mild
diarrhea
to fatal
colitis
. If CDAD is confirmed, discontinue therapy and treat appropriately.
Rash
in Patients with
Mononucleosis
: A high percentage of patients with
mononucleosis
who receive
amoxicillin
(a component of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK) develop an
erythematous skin rash
. Avoid use of both products in patients with
mononucleosis
. Interactions with Diagnostic Investigations for
Neuroendocrine Tumors
: Serum
chromogranin A (CgA)
levels increase secondary to drug-induced decreases in gastric acidity. The increased
CgA
level may cause false positive results in diagnostic investigations for
neuroendocrine tumors
. Assess CgA levels at least 14 days after VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK treatment and consider repeating the test if initial CgA levels are high. VOQUEZNA TRIPLE PAK Warnings or Precautions Due to the
Clarithromycin
Component: QT Prolongation: Avoid VOQUEZNA TRIPLE PAK in patients with known
QT prolongation
or receiving drugs known to prolong the QT interval,
ventricular arrhythmia
(
torsades de pointes
),
hypokalemia
/
hypomagnesemia
, significant
bradycardia
, or taking Class IA or III antiarrhythmics. Hepatotoxicity: Discontinue use of VOQUEZNA TRIPLE PAK if signs and symptoms of
hepatitis
occur. Serious adverse reactions due to concomitant use with other drugs: Serious adverse reactions can occur with VOQUEZNA TRIPLE PAK due to drug interactions of
clarithromycin
with
colchicine
, some lipid lowering agents, some
calcium channel blockers
, hypoglycemic agents including
insulin
,
quetiapine
,
warfarin
,
benzodiazepines
, and other drugs. Embryo-Fetal Toxicity: VOQUEZNA TRIPLE PAK is not recommended for use in pregnancy as
clarithromycin
may cause fetal harm.
Myasthenia Gravis
: Exacerbation of
myasthenia gravis
can occur with VOQUEZNA TRIPLE PAK since it has been reported in patients receiving
clarithromycin
tablets. ADVERSE REACTIONS VOQUEZNA TRIPLE PAK: The most common adverse reactions (≥2%) include
dysgeusia
(4.6%),
diarrhea
(4.0%),
vulvovaginal candidiasis
(3.2%),
headache
(2.6%),
abdominal pain
(2.3%), and
hypertension
(2.0%). VOQUEZNA DUAL PAK: The most common adverse reactions (≥2%) include
diarrhea
(5.2%),
abdominal pain
(2.6%),
vulvovaginal candidiasis
(2.0%), and
nasopharyngitis
(2.0%). DRUG INTERACTIONS Components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK have the potential for clinically important drug interactions. See full Prescribing Information for important drug interactions. USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended during treatment, but a lactating woman can pump and discard breast milk during treatment and for 2 days after VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK administration. Geriatrics: VOQUEZNA TRIPLE PAK increased risk of torsades de pointes due to
clarithromycin
.
Renal and Hepatic Impairment
: Avoid use in patients with severe
renal impairment
and avoid use in patients with moderate to severe hepatic impairment. You are encouraged to report suspected adverse reactions by contacting
Phathom Pharmaceuticals
at 1-888-775-PHAT (7428) or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. Forward Looking Statements
Phathom
cautions you that statements contained in this press release 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 availability of results from the PHALCON-NERD-301 trial, whether such trial will form the basis for an sNDA for
vonoprazan
as a once-daily treatment for NERD, and the timing for the submission of such sNDA with the FDA. 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 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;
Phathom
’s ability to successfully launch and commercialize
vonoprazan
; 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 obtain and maintain intellectual property protection for vonoprazan;
Phathom
’s ability to comply with its license agreement with
Takeda
;
Phathom
’s ability to maintain undisrupted business operations due to the ongoing impact of the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain and launch and commercialization efforts;
Phathom
’s ability to achieve and maintain adequate levels of coverage and reimbursement for vonoprazan;
Phathom
’s ability to access additional capital under each of its term loan facility and its revenue interest financing agreement is subject to certain conditions, 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. INVESTOR AND MEDIA CONTACT Nick Benedetto 1-877-742-8466 media@phathompharma.com ir@phathompharma.com © 2022
Phathom Pharmaceuticals
. All rights reserved. VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK,
Phathom Pharmaceuticals
, and their respective logos are registered trademarks or trademarks of
Phathom Pharmaceuticals, Inc.
10/22 US-VPZ-22-0314 __________________ 1 Chen CL, Hsu PI. Current advances in the diagnosis and treatment of
nonerosive reflux disease
. Gastroenterol Res Pract. 2013;2013:653989. 2 Fass R and Frazier R. The role of
dexlansoprazole
modified-release in the management of
gastroesophageal reflux disease
. Therap Adv Gastroenterol. 2017 Feb;10(2):243-251. 3 Lee SW, Lee TY, Lien HC, Yang SS, Yeh HZ, Chang CS. Characteristics of symptom presentation and risk factors in patients with
erosive esophagitis
and
nonerosive reflux disease
. Med PrincPract. 2014;23(5):460-4. 4 Modlin IM, Hunt RH, Malfertheiner P, Moayyedi P,
Quigley EM
, Tytgat GN, et al; Vevey NERD Consensus Group. Diagnosis and management of non-erosive reflux disease--the Vevey NERD Consensus Group. Digestion. 2009;80(2):74-88.
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机构
Phathom Pharmaceuticals, Inc.
Takeda Pharmaceutical Co., Ltd.
Quigley Co.
适应症
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