Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) presented new Phase 2 data from its investigative drug candidates etrasimod, a next-generation, oral, selective sphingosine 1 phosphate (S1P) receptor modulator in development for the treatment of moderate to severely active ulcerative colitis (UC), and olorinab, a peripherally restricted, highly selective, full agonist of the cannabinoid receptor type 2 (CB2) in development for the treatment of visceral pain associated with gastrointestinal (GI) diseases, at the 14th Congress of European Crohn’s and Colitis Organisation (ECCO).
“The new data presented from the Phase 2 trial of etrasimod demonstrate that both mucosal healing and histological remission were seen in patients with moderate to severe ulcerative colitis following just 12 weeks of treatment,” said Laurent Peyrin-Biroulet, MD PhD, Professor of Medicine and Head of the Inflammatory Bowel Disease Unit, Inserm, University Hospital of Nancy, France. “These results continue to support etrasimod’s potential as an important future therapy and we look forward to further validating these data in the soon to be initiated ELEVATE Phase 3 clinical program for etrasimod in UC.”
Etrasimod Presentation Details – Awarded “Top-10 Oral Poster 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 Colitis
“Non-opioid-based treatments for visceral pain associated with Crohn’s disease address an area of significant unmet need, especially in patients in whom nonsteroidals and opioids are restricted,” stated Peter Doyle Higgins MD, PhD, Professor, Director of Inflammatory Bowel Disease Program, Director of Ambulatory and Chronic Disease Clinical Trials Support Unit, University of Michigan. “These data from the olorinab program highlight its potential as a novel approach for the management of GI pain that may lack abuse potential. I look forward to further clinical studies of this promising candidate therapy in Crohn’s disease and IBS with the hopes of providing a new treatment option to patients in need of relief from chronic abdominal pain.”
Olorinab Presentation Details Title: Safety and Efficacy of Olorinab, a Peripherally Restricted, Highly-Selective, Cannabinoid Receptor 2 Agonist in a Phase 2a Study in Chronic Abdominal Pain Associated with Crohn’s Disease
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 restricted, highly selective, full agonist of cannabinoid receptor type 2 (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’s licensee, United Therapeutics, is evaluating ralinepag in a Phase 3 program for pulmonary arterial hypertension (PAH).
Arena has additional license agreements and partnerships, including with 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 “potential,” “future,” “look forward to,” “soon to be,” “may,” “promising,” “hopes of,” “designed to,” “in development for,” “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, have broad clinical utility, lack abuse potential, or satisfy an unmet medical need; Arena’s drive; 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 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 Annual Report on Form 10-K for the year ended December 31, 2018, which was filed with the SEC on February 28, 2019. 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.
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