FLORHAM PARK, N.J., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that data for vonoprazan, an investigational potassium competitive acid blocker (P-CAB) in late clinical-stage development for the treatment of gastric acid-related disorders, will be presented at the ACG 2021 Annual Scientific Meeting in Las Vegas, Nevada, organized by the American College of Gastroenterology, October 22-27.
During the scientific congress, new data on vonoprazan will be shared in addition to novel insights into the burden of acid-related diseases, analysis of treatment patterns, and other newfound developments.
“Phathom is committed to its mission as we seek to change the landscape for acid-related diseases,” said Eckhard Leifke, M.D., Chief Medical Officer of Phathom. “We’ve conducted extensive research specifically on H. pylori and erosive esophagitis and look forward to sharing our data as well as updates on the disease burden for patients and providers with the GI community at the ACG 2021 Annual Scientific Meeting.”
In addition to four poster sessions and one oral presentation, Phathom will sponsor a product theater highlighting unmet needs in the treatment of H. pylori and will also have a presence on the exhibit floor at booth #929 throughout the conference and virtually via RethinkGIAcid.com.
A high-level schedule of Phathom activities at the ACG 2021 Annual Scientific Meeting can be found below:
Sunday, October 24, 2021
- Phathom Poster Session
3:30 PM – 7:00 PM - Phathom Poster Session
3:30 PM – 7:00 PM
Monday, October 25, 2021
- Phathom Poster Session
10:30 AM – 4:15 PM - Phathom Oral Session
2:15 PM – 2:25 PM
Tuesday, October 26, 2021
- Medscape CME symposium sponsored by Phathom
6:00 AM – 7:00 AM
Presenters: Drs. William D. Chey, Colin Howden, Shailja Shah - Phathom Poster Session
10:30 AM – 4:15 PM - Product Theater sponsored by Phathom
10:35 AM – 11:30 AM
Phathom will attend ACG 2021 having recently announced positive data from its pivotal Phase 3 PHALCON-EE trial which studied vonoprazan as a treatment option for erosive esophagitis (EE).
Two New Drug Applications (NDAs) for vonoprazan-based regimens for the treatment of H. pylori infection were submitted to the U.S. FDA in September 2021. Based on the positive PHALCON-EE trial, Phathom also plans to submit an NDA to the FDA for the healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn by the end of the first half of 2022.
About Vonoprazan
Vonoprazan 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 awarded qualified infectious disease product (QIDP) status and granted Fast Track designation to vonoprazan in combination with both amoxicillin and clarithromycin and with amoxicillin alone for the treatment of H. pylori infection. Phathom submitted NDAs in September 2021 to the FDA for vonoprazan-based regimens 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 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 www.phathompharma.com and follow the Company on LinkedIn and Twitter.
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 submission of an NDA for healing and maintenance of healing of all grades of erosive esophagitis and relief of heartburn. 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: reported top-line data is based on preliminary analysis of key efficacy and safety data is subject to more audit and verification procedures that could result in material changes in the final data; we may experience delays submitting the NDA including in the event that the FDA does not agree with the Company’s interpretation of the data or feedback from the FDA that may be inconsistent with feedback received at prior meetings with the FDA; Phathom’s ability to access additional capital under the term loan facility is subject to certain conditions including verification by the lender that the clinical milestone has been met; 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 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 Benedetto
1-877-742-8466
media@phathompharma.com
Investor Contact:
Joe Hand
1-877-742-8466
ir@phathompharma.com
