Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) today announced that data from its OASIS Phase 2 clinical study for its investigational drug candidate etrasimod, a next-generation, oral, S1P receptor modulator with optimized activity being evaluated in ulcerative colitis (UC), were presented by Dr. William J. Sandborn at the American College of Gastroenterology Annual Meeting. The paper was awarded the 2018 ACG Auxiliary Award Recipient (Member).
“We are pleased to share data which we believe further support a direct readthrough to our Phase 3 program in UC. Our Phase 2 results demonstrated the potential of etrasimod to allow patients to achieve clinical remission and meaningful improvements in the endpoints measured,” said Preston Klassen, MD, MHS, Executive Vice President, Research and Development and Chief Medical Officer of Arena. “We look forward to additional discussions with the regulatory agencies and moving rapidly into Phase 3.”
These data will also be presented at the United European Gastroenterology Week (UEGW) in Vienna later this month.
Presentation DetailsTitle: A Randomized, Double-Blind, Placebo-Controlled Trial of a Selective, Oral Sphingosine 1-Phosphate (S1P) Receptor Modulator, Etrasimod (APD334), in Moderate to Severe Ulcerative Colitis (UC): Results From the OASIS Study When: Monday, October 8, 2018, 2:15 PM – 2:25 PM EDT
About EtrasimodEtrasimod (APD334), is a next generation, oral, selective sphingosine 1 phosphate (S1P) receptor modulator, discovered by Arena, designed to provide systemic and local cell modulation by selectively targeting S1P receptor subtypes 1,4 and 5. Etrasimod has therapeutic potential in immune and inflammatory-mediated diseases such as ulcerative colitis, Crohn’s disease, primary biliary cholangitis (PBC) and atopic dermatitis. S1P receptors have been demonstrated to be involved in the modulation of several biological responses, including lymphocyte trafficking from lymph nodes to the peripheral blood. By isolating subpopulations of lymphocytes in lymph nodes, fewer immune cells are available in the circulating blood to effect tissue damage.
Etrasimod is an investigational compound that is not approved for any use in any country.
About Arena PharmaceuticalsArena Pharmaceuticals is focused on delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena’s proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), in a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), expected to commence a Phase 3 program for ulcerative colitis (UC) and a program in Crohn’s disease (CD), and which has potential utility for a broad range of immune and inflammatory-mediated. Arena is also evaluating olorinab (APD371) for the treatment of gastrointestinal pain, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including with Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin – Phase 2), Boehringer Ingelheim International GmbH (undisclosed target – preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® – marketed product).
Forward-Looking StatementsCertain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as “potentially,” “focused on,” “expected,” “next-generation,” or words of similar meaning, or they may be identified by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about the following: the opportunity and potential of etrasimod and Arena’s other investigational drug candidates, including to be first- or best-in-class; the significance of Phase 2 data; discussions with regulatory agencies; and the Phase 3 clinical programs for etrasimod, including about timing; and Arena’s focus, goals, strategy, clinical programs and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena’s expectations. Factors that could cause actual results to differ materially from the forward-looking statements include: results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; the timing and outcome of research, development and regulatory review is uncertain; we expect to need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; clinical trials and other studies may not proceed at the time or in the manner expected or at all; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; our drug candidates may not advance in development or be approved for marketing; unexpected or unfavorable new data; risks related to developing and commercializing drugs; risks related to relying on partners and other third parties; Arena’s and third parties’ intellectual property rights; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena’s forward-looking statements are disclosed in Arena’s filings with the Securities and Exchange Commission (SEC), including but not limited to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which was filed with the SEC on August 7, 2018. These forward-looking statements represent Arena’s judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:Kevin R. LindArena Pharmaceuticals, Inc.Executive Vice President andChief Financial Officerklind@arenapharm.com858.210.3636
Media Contact:Matt Middleman, M.D.LifeSci Public Relationsmatt.firstname.lastname@example.org
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