Phathom Pharmaceuticals Reports First Quarter 2021 Results
11 May 2021
CollaborateFinancial StatementSmall molecular drugQualified Infectious Disease ProductFast Track
FLORHAM PARK, N.J., May 11, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the first quarter of 2021 and provided an update on its recent clinical and organizational progress.
“With both the impressive results from our pivotal Phase 3 PHALCON-HP trial and the initiation of our NERD development program, Phathom marks a strong start to 2021 having accomplished two of our key strategic imperatives for the year,” said Terrie Curran, Phathom’s President and Chief Executive Officer. “We are well-positioned to further build on this positive momentum as we anticipate several other significant catalysts in 2021 – including the expected readout from our pivotal Phase 3 trial in erosive esophagitis and the planned NDA submissions for vonoprazan-based regimens in the treatment of H. pylori infection.”
PHALCON-HP Clinical Development and Regulatory Updates:
Other Clinical and Business Updates:
First Quarter 2021 Financial Results:
About VonoprazanVonoprazan is an investigational, oral small molecule potassium-competitive acid blocker (P-CAB). P-CABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan has shown the potential to have rapid, potent, and durable anti-secretory effects as a single agent in the treatment of gastroesophageal reflux disease (GERD) and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection. The FDA has designated vonoprazan in combination with both amoxicillin and clarithromycin and with amoxicillin alone as qualified infectious disease products (QIDP) and awarded them Fast Track status for the treatment of H. pylori infection. Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which completed 19 Phase 3 trials for vonoprazan and received marketing approval in Japan and numerous other countries in Asia and Latin America.
About PHALCON-HPPHALCON-HP was a randomized, multicenter, Phase 3 trial that enrolled 1046 patients of which 992 patients with a confirmed H. pylori infection were randomized to one of three arms: vonoprazan 20 mg administered twice a day (BID) and amoxicillin 1g administered three times a day (TID) (n=324); vonoprazan 20 mg BID, amoxicillin 1g BID and clarithromycin 500 mg BID (n=338); and lansoprazole 30 mg BID, amoxicillin 1g BID and clarithromycin 500 mg BID (n=330). Each treatment regimen was administered for 14 days. Diagnoses of infection and test of cure were confirmed by 13C-urea breath test. Additional efficacy analyses were conducted using the pre-specified per protocol population (n=822), a subset of the mITT population comprised of patients who were protocol compliant.
About PHALCON-EEPHALCON-EE is a randomized, double-blind, two-phase, multicenter Phase 3 trial that has completed enrollment of patients with erosive esophagitis (EE) in the U.S. and Europe. The first phase of the trial is evaluating the efficacy and safety of vonoprazan 20 mg administered once-daily (QD) compared to lansoprazole 30 mg QD for the healing of EE for up to eight weeks. The second phase of the trial is evaluating the efficacy and safety of vonoprazan 10 mg QD and 20 mg QD compared to lansoprazole 15 mg QD for the maintenance of healing of EE for 24 weeks. Both phases are also evaluating heartburn symptoms.
About PHALCON-NERD on-demandPHALCON-NERD on-demand is a randomized, double-blind, multicenter Phase 2 study evaluating the efficacy and safety of various doses of vonoprazan compared to placebo for relief of episodic heartburn in subjects with symptomatic non-erosive gastroesophageal reflux disease or NERD. The first phase of the trial is a four-week, open-label run-in period with daily dosing of vonoprazan 20 mg. Following the run-in period, responders will be evenly randomized to one of three doses of vonoprazan (10 mg, 20 mg, and 40 mg) or placebo and treated on-demand for six weeks. The primary endpoint is evaluating the proportion of heartburn episodes with complete and durable relief. Secondary endpoints will also assess different aspects of the speed of onset of symptom relief and durability of relief, as well as number of doses of study drug and use of rescue antacids.
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 novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. For more information about Phathom, visit the Company’s website at or follow the Company on social media: LinkedIn at and Twitter @PhathomPharma.
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 topline results from the PHALCON-EE Phase 3 clinical trial; the expected submission of New Drug Applications for the eradication of H. pylori infection; the expected completion of enrollment in the Phase 2 NERD study; and Phathom’s belief that vonoprazan could represent an important treatment option for acid-related diseases, if approved. 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: potential additional delays in the commencement, enrollment and completion of clinical trials due to the COVID-19 pandemic and other factors outside of Phathom’s control; patients already enrolled in PHALCON-EE and the Phase 2 NERD study may not complete the clinical trials or public health conditions and governmental restrictions may lead Phathom to stop such trial all together, which may adversely impact its trial results and development plans; 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; QIDP and Fast Track designations may be withdrawn or not actually lead to a faster development or regulatory review or extended exclusivity, and would not assure FDA approval of vonoprazan; 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 spread of the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain, 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.
CONTACTS
Media Contact:Nick Benedetto1-877-742-8466media@phathompharma.com
Investor Contact:Todd Branning 1-877-742-8466ir@phathompharma.com
PHATHOM PHARMACEUTICALS, INC.Balance Sheets (Unaudited)(in thousands, except share and par value amounts)
PHATHOM PHARMACEUTICALS, INC. Statements of Operations and Comprehensive Loss (Unaudited)(in thousands, except share and per share amounts)
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