Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) today announced that it has initiated sites for its ELEVATE UC Phase 3 global program to evaluate etrasimod 2 mg in subjects with moderately to severely active ulcerative colitis (UC). Arena will present new data from its investigative drug candidates etrasimod, a next-generation, once-daily, oral, selective sphingosine 1 phosphate (S1P) receptor modulator, and olorinab, a peripherally acting, highly selective, full agonist of the cannabinoid type 2 receptor (CB2) in development for the treatment of visceral pain associated with gastrointestinal (GI) diseases, at Digestive Disease Week® (DDW). DDW is the world’s largest gathering of physicians, researchers and industry in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. In addition to the presentations, Arena Pharmaceuticals will have a booth at DDW located in the exhibit hall, booth #3417.
“We are thrilled that we have initiated sites for our Phase 3 ELEVATE UC program. This further reinforces our commitment to bringing a potential new therapy to inflammatory bowel disease patients globally, and brings us one step closer to that goal,” stated Preston Klassen, MD, MHS, Executive Vice President, Research and Development and Chief Medical Officer of Arena. “We hope to address the significant unmet need that still affects 60-80% of IBD patients, who are either not receiving or failing on current standard of care.”
Presentation Title: Histologic Remission and Mucosal Healing in a Randomized, Placebo-Controlled, Phase 2 Study of Etrasimod in Patients with Moderately to Severely Active Ulcerative ColitisPresenter: Laurent Peyrin-Biroulet, MD, PhDSession Date: May 21, 2019 Presentation Time: 10:45 AM – 11:00 AMLocation: Room 20BCD
Presentation Title: Correlation of Fecal Calprotectin and C-Reactive Protein Concentrations with Clinical Outcomes and Endoscopic Disease Activity in Patients with Ulcerative Colitis Receiving Induction Therapy with Etrasimod Presenter: Andres Yarur, MD Poster Session Date: May 21, 2019Session Time: 12:00 PM – 2:00 PMPoster Number: Tu1745 Location: Hall C-E
Presentation Title: Olorinab, a Peripherally Acting, Highly Selective, Full Agonist of the Cannabinoid Type 2 Receptor (CB2), Reduces Visceral Hypersensitivity in Animal Models Presenter: Stuart M. Brierley, PhDPoster Session Date: May 18, 2019Session Time: 12:00 PM – 2:00 PMPoster Number: Sa1738Location: Halls C-E
Presentation Title: Safety and Efficacy of Olorinab, a Peripherally Acting, Highly Selective, Cannabinoid Type 2 Receptor Agonist in a Phase 2a Study in Chronic Abdominal Pain Associated with Crohn’s DiseasePresenter: Bruce Yacyshyn, MDPoster Session Date: May 19, 2019SessionTime: 12:00 PM – 2:00 PMPoster Number: Su1930Location: Halls C-E
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, 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 OlorinabOlorinab (APD371) is an oral, peripherally acting, highly selective, full agonist of cannabinoid type 2 receptor (CB2) in development for the treatment of visceral pain associated with gastrointestinal (GI) diseases, including Crohn’s disease and irritable bowel syndrome (IBS). Evidence that CB2 are expressed in multiple cell types of the GI tract, and modulate intestinal inflammation and visceral hypersensitivity, make CB2 an attractive target for the treatment of abdominal pain in GI disorders.
Olorinab is an investigational compound that is not approved for any use in any country.
About Arena PharmaceuticalsArena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena’s proprietary pipeline includes multiple potentially first- or best-in-class assets with broad clinical utility. Etrasimod (APD334), with potential utility in a broad range of immune and inflammatory conditions, is being evaluated in later-stage clinical programs in ulcerative colitis (UC) and Crohn’s disease, as well as in programs for other indications such as atopic dermatitis. Arena is also evaluating olorinab (APD371) in a Phase 2 program for gastrointestinal pain. Arena continues to assess other earlier research and development stage drug candidates, including APD418 for decompensated heart failure.
Arena has additional license agreements and partnerships, including with United Therapeutics (ralinepag in a Phase 3 program for pulmonary arterial hypertension), Everest Medicines Limited (etrasimod in Greater China and select Asian countries), 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 “will,” “in development for,” “potential,” “goal,” “hope to,” “designed to,” “driven to,” “potentially,” 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, development and potential of etrasimod, olorinab and Arena’s other investigational drug candidates, including to be first- or best-in-class or next-generation, have broad clinical utility, or satisfy an unmet medical need; Arena’s drive, commitment, and goals; and the potential of Arena’s assets, programs, licenses, 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: the timing and outcome of research, development and regulatory review is uncertain; 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; 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, licensees 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 its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. 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 and Chief Financial Officer email@example.com 858.210.3636
Media Contact:Matt Middleman, MDLifeSci Public Relationsmatt.firstname.lastname@example.org 646.627.8384
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