Phathom Pharmaceuticals Presents New Data Evaluating

FLORHAM PARK, N.J., Oct. 23, 2022 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical firm centered on growing and commercializing novel remedies for gastrointestinal ailments and issues, introduced right now that detailed outcomes from an investigational Phase 2 research evaluating the efficacy of vonoprazan in non-erosive gastroesophageal reflux illness (NERD) and different information will probably be introduced on the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting, being held October 21-26 in Charlotte, NC.

PHALCON-NERD On-Demand
In an oral plenary session throughout ACG, detailed outcomes from the Phase 2 PHALCON-NERD trial learning vonoprazan as a each day dosing and on-demand remedy for aid of episodic heartburn in sufferers with NERD will probably be introduced by Ronnie Fass, M.D., director of the Division of Gastroenterology and Hepatology and medical director of the Digestive Health Center at MetroHealth in Cleveland, Ohio and lead investigator of the PHALCON-NERD trial. This presentation is the primary launch of secondary and exploratory endpoint analyses since Phathom shared topline information from the research in February 2022.

The double-blind, placebo-controlled PHALCON-NERD research randomized 207 sufferers who have been eligible for on-demand (“as needed”) remedy following a 4-week each day dosing run-in interval wherein sufferers acquired vonoprazan 20 mg once-daily. Patients with out heartburn within the final seven days of the run-in interval have been evenly randomized to obtain 10 mg, 20 mg or 40 mg of vonoprazan or placebo for six weeks.

Key outcomes embody:

• The main endpoint was met for all three doses of vonoprazan, demonstrating full and sustained aid in 56% (10 mg), 60.6% (20 mg) and 70% (40 mg) of heartburn episodes was achieved inside three hours with no additional heartburn reported for twenty-four hours within the on-demand interval, in comparison with placebo (27.3%, p<0.0001).
• In exploratory endpoints, the onset of full and sustained aid of heartburn episodes was additionally evaluated at intervals of half-hour, 1 hour, 1.5 hours, 2 hours, and three hours after taking vonoprazan to find out the earliest level of full symptom aid.
• Significant variations in full and sustained aid occurred throughout all doses of vonoprazan in as early as one hour after dosing within the on-demand interval and was maintained for over 24 hours.
• In the on-demand interval, vonoprazan had no treatment-emergent hostile occasions (AEs) reported by >1 affected person per remedy group. Additionally, 16.3%, 18.4%, and 16.7% of sufferers handled with vonoprazan 10, 20, and 40 mg, respectively reported a treatment-emergent hostile occasion (TEAE) in comparison with 21.3% of sufferers receiving placebo.

“These results from the Phase 2 PHALCON-NERD study are very encouraging and demonstrate the potential of vonoprazan to be taken as-needed by patients with NERD who experience episodic heartburn symptoms and require rapid and sustained relief,” mentioned Ronnie Fass, M.D. “NERD is a common cause of reflux-related symptoms and some patients with NERD fail to respond adequately to PPI therapy. This study suggests that the rapid suppression of gastric acid by vonoprazan translates into clinical benefits for patients with NERD when taken on demand.”

In addition, Phathom is actively conducting a Phase 3 PHALCON-NERD Daily Dosing trial to judge vonoprazan as a each day dosing remedy of heartburn related to NERD. Topline information for the first endpoint are anticipated in early 2023, with full outcomes anticipated in late 2023.

“The data being presented at this year’s ACG further highlights Phathom’s commitment to its mission to transform treatment for patients with gastrointestinal diseases and disorders,” mentioned Azmi Nabulsi, M.D., Chief Operating Officer at Phathom. “We are excited to share more detailed results of our Phase 2 on-demand trial and look forward to generating additional insights about vonoprazan as a potential daily preventative therapy in patients with NERD in our ongoing Phase 3 trial. Our continued research program demonstrates the promise of a new mechanism of action to provide more effective acid control with the potential to address unmet needs in the treatment of NERD and other acid-related GI conditions.”

PK/PD Model Study
Also throughout ACG, Dr. Carmelo Scarpignato, Professor of Medicine & Clinical Pharmacology on the United Campus of Malta, and General Secretary, World Organization for Esophageal Diseases (OESO), will current a poster (Presentation #: E0193) on a pharmacokinetics (PK) and pharmacodynamics (PD) research. Pooled information from 5 Phase 1 research have been used to develop a PK/PD mannequin to research the connection between vonoprazan remedy and pH HTR. The pooled information included pH measurements for 245 contributors from Japan and Western nations.

Key outcomes embody:

• Simulations confirmed that vonoprazan 20 mg once-daily (QD) and 20 mg twice-daily (BID) are predicted to present pH>4 HTRs of 89.7% and 98.1%, respectively, by Day 7.
• HTRs for pH>6 have been 53.1% for vonoprazan 20 mg QD and 75.3% for BID.

The research discovered vonoprazan offered excessive, dose-dependent pH holding time ratios (HTR) in keeping with dose-dependent management of 24-hour intragastric acidity. The extent of gastric acid suppression has been proven to be an vital issue within the remedy of acid-related gastrointestinal issues, suggesting vonoprazan may have potential utility for a variety of acid-related gastrointestinal issues.

Following the conclusion of ACG 2022, the abstracts will probably be posted to Phathom’s publications and scientific part of the corporate web site.

About Phathom Pharmaceuticals, Inc.
Phathom Pharmaceuticals is a biopharmaceutical firm centered on the event and commercialization of novel remedies for gastrointestinal ailments and issues. Phathom has in-licensed the unique rights within the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). Vonoprazan-based regimens are authorised within the U.S. as a part of a co-packaged product together with antibiotics for the remedy of H. pylori an infection in adults, marketed as VOQUEZNA™ TRIPLE PAK™ (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA™ DUAL PAK™ (vonoprazan, amoxicillin). Phathom has a New Drug Application below assessment by the FDA for vonoprazan in erosive esophagitis (EE) and is learning using vonoprazan for the remedy of non-erosive reflux illness (NERD). For extra details about Phathom, go to the Company’s web site at www.phathompharma.com and observe the Company on LinkedIn and Twitter.

About Non-Erosive Gastroesophageal Reflux Disease (NERD)
NERD is the most important subcategory of gastroesophageal reflux illness (GERD) and is characterised by reflux-related signs within the absence of esophageal mucosal erosions.^1,2 There are estimated to be over 65 million people with GERD within the U.S., and it’s estimated that seventy % (70%) of this inhabitants have NERD. Symptoms of NERD impression total high quality of life and might embody episodic heartburn, particularly at evening, regurgitation, issues swallowing, and chest ache.^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 merchandise are indicated for the remedy of Helicobacter pylori an infection in adults.

To cut back the event of drug-resistant micro organism and preserve the effectiveness of VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, and different antibacterial medicine, each merchandise must be used solely to deal with or stop infections which can be confirmed or strongly suspected of being brought on by micro organism.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are contraindicated in sufferers with recognized hypersensitivity to vonoprazan or amoxicillin, every other elements of the formulation, every other beta-lactams, or in sufferers receiving rilpivirine-containing merchandise.

Due to the clarithromycin part, VOQUEZNA TRIPLE PAK can also be contraindicated in sufferers with any recognized hypersensitivity to clarithromycin or any macrolide antibiotic, in sufferers receiving pimozide, lomitapide, lovastatin, simvastatin, ergotamine, dihydroergotamine, colchicine in sufferers with renal or hepatic impairment, or these with a historical past of cholestatic jaundice/hepatic dysfunction.

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Serious and infrequently deadly reactions (e.g., anaphylaxis) have been reported with elements of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. If hypersensitivity reactions happen, discontinue use and institute fast remedy (e.g., anaphylaxis administration).

Severe Cutaneous Adverse Reactions (SCAR): Discontinue use of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK at first indicators or signs of SCAR or different indicators of hypersensitivity and think about additional analysis. SCAR, together with Stevens-Johnson syndrome (SJS) and poisonous epidermal necrolysis (TEN) have been reported with the elements of each merchandise. In addition, drug response with eosinophilia and systemic signs (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with amoxicillin and clarithromycin.

Clostridioides difficile-associated diarrhea (CDAD): Evaluate if diarrhea happens with VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK. CDAD has been reported with use of acid suppressing therapies and practically all antibacterial brokers, and will vary in severity from delicate diarrhea to deadly colitis. If CDAD is confirmed, discontinue remedy and deal with appropriately.

Rash in Patients with Mononucleosis: A excessive share of sufferers with mononucleosis who obtain amoxicillin (a part of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK) develop an erythematous pores and skin rash. Avoid use of each merchandise in sufferers with mononucleosis.

Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Serum chromogranin A (CgA) ranges improve secondary to drug-induced decreases in gastric acidity. The elevated CgA degree might trigger false optimistic ends in diagnostic investigations for neuroendocrine tumors. Assess CgA ranges a minimum of 14 days after VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK remedy and think about repeating the take a look at if preliminary CgA ranges are excessive.

VOQUEZNA TRIPLE PAK Warnings or Precautions Due to the Clarithromycin Component:
QT Prolongation: Avoid VOQUEZNA TRIPLE PAK in sufferers with recognized QT prolongation or receiving medicine recognized to lengthen the QT interval, ventricular arrhythmia (torsades de pointes), hypokalemia/hypomagnesemia, vital bradycardia, or taking Class IA or III antiarrhythmics.

Hepatotoxicity: Discontinue use of VOQUEZNA TRIPLE PAK if indicators and signs of hepatitis happen.

Serious hostile reactions resulting from concomitant use with different medicine: Serious hostile reactions can happen with VOQUEZNA TRIPLE PAK resulting from drug interactions of clarithromycin with colchicine, some lipid reducing brokers, some calcium channel blockers, hypoglycemic brokers together with insulin, quetiapine, warfarin, benzodiazepines, and different medicine.

Embryo-Fetal Toxicity: VOQUEZNA TRIPLE PAK just isn’t really helpful to be used in being pregnant as clarithromycin might trigger fetal hurt.

Myasthenia Gravis: Exacerbation of myasthenia gravis can happen with VOQUEZNA TRIPLE PAK because it has been reported in sufferers receiving clarithromycin tablets.

ADVERSE REACTIONS
VOQUEZNA TRIPLE PAK: The commonest hostile reactions (≥2%) embody dysgeusia (4.6%), diarrhea (4.0%), vulvovaginal candidiasis (3.2%), headache (2.6%), belly ache (2.3%), and hypertension (2.0%).

VOQUEZNA DUAL PAK: The commonest hostile reactions (≥2%) embody diarrhea (5.2%), belly ache (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 vital drug interactions. See full Prescribing Information for vital drug interactions.

USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding not really helpful throughout remedy, however a lactating girl can pump and discard breast milk throughout remedy and for two days after VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK administration.

Geriatrics: VOQUEZNA TRIPLE PAK elevated threat of torsades de pointes resulting from clarithromycin.

Renal and Hepatic Impairment: Avoid use in sufferers with extreme renal impairment and keep away from use in sufferers with average to extreme hepatic impairment.

You are inspired to report suspected hostile reactions by contacting Phathom Pharmaceuticals at 1-888-775-PHAT (7428) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK.

Forward Looking Statements
Phathom cautions you that statements contained on this press launch concerning issues that aren’t historic information are forward-looking statements. These statements are primarily based on the Company’s present beliefs and expectations. The inclusion of forward-looking statements shouldn’t be thought to be a illustration by Phathom that any of its plans will probably be achieved. Actual outcomes might differ from these set forth on this press launch as a result of dangers and uncertainties inherent in Phathom’s business, together with, with out limitation: the inherent dangers of scientific improvement of vonoprazan; Phathom’s dependence on third events in reference to product manufacturing, analysis and preclinical and scientific testing; regulatory developments within the United States and overseas nations; Phathom’s potential to efficiently launch and commercialize vonoprazan; surprising hostile uncomfortable side effects or insufficient efficacy of vonoprazan that will restrict its improvement, regulatory approval and/or commercialization, or might end in remembers or product legal responsibility claims; Phathom’s potential to acquire and preserve mental property safety for vonoprazan; Phathom’s potential to adjust to its license settlement with Takeda; Phathom’s potential to keep up undisrupted business operations as a result of ongoing impression of the COVID-19 coronavirus, together with delaying or in any other case disrupting its scientific trials, manufacturing and provide chain and launch and commercialization efforts; Phathom’s potential to realize and preserve sufficient ranges of protection and reimbursement for vonoprazan; Phathom’s potential to entry extra capital below its time period mortgage facility is topic to sure circumstances, and different dangers described within the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), together with below the heading “Risk Factors” within the Company’s Annual Report on Form 10-Okay and any subsequent filings with the SEC. You are cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date hereof, and Phathom undertakes no obligation to replace such statements to replicate occasions that happen or circumstances that exist after the date hereof. All forward-looking statements are certified of their entirety by this cautionary assertion, which is made below the protected harbor provisions of the Private Securities Litigation Reform Act of 1995.

INVESTOR AND MEDIA CONTACT
Nick Benedetto
1-877-742-8466
[email protected]
[email protected]

© 2022 Phathom Pharmaceuticals. All rights reserved.
VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, Phathom Pharmaceuticals, and their respective logos are registered logos or logos of Phathom Pharmaceuticals, Inc.

10/22 US-VPZ-22-0274

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¹ Chen CL, Hsu PI. Current advances within the analysis and remedy of nonerosive reflux illness. Gastroenterol Res Pract. 2013;2013:653989.
² Fass R and Frazier R. The position of dexlansoprazole modified-release within the administration of gastroesophageal reflux illness. 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 threat elements in sufferers with erosive esophagitis and nonerosive reflux illness. Med Princ Pract. 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 administration of non-erosive reflux disease–the Vevey NERD Consensus Group. Digestion. 2009;80(2):74-88.