Arena Pharmaceuticals Announces First Subject Dosed in ADVISE Phase 2 Trial Evaluating Etrasimod in Atopic Dermatitis
- ADVISE clinical trial initiated and enrollment progressing
- Evaluating patients with the clinical diagnosis of moderate-to-severe atopic dermatitis
- Significant unmet need for an oral therapy in atopic dermatitis
"I am pleased that Arena is currently enrolling patients in its Phase 2 ADVISE study, advancing an oral agent with a novel mechanism of action for the potential treatment of atopic dermatitis," said
"The decision to move into dermatology, and specifically atopic dermatitis, is founded on scientific, preclinical and early clinical supporting evidence," stated
ADVISE is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study (with an open-label extension) to assess the safety and efficacy of once-daily etrasimod in subjects with moderate-to-severe atopic dermatitis. The primary endpoint is percent change in Eczema Area and Severity Index (EASI) from baseline to week 12, followed by a 4-week follow-up observation period. The ADVISE trial will enroll approximately 120 subjects and will be conducted in study sites across
About Atopic Dermatitis
Atopic dermatitis (AD) is a serious, chronic immune-mediated disease in which symptoms vary, but often include severe dry skin, itching, patches, swollen skin and raised bumps which may leak fluid.
Etrasimod (APD334) is a next generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator discovered by Arena, and designed for optimized pharmacology and engagement of S1P receptor 1, 4 and 5 which may lead to an improved efficacy and safety profile.
Etrasimod provides systemic and local effects on specific immune cell types and has the potential to treat multiple immune-mediated inflammatory diseases including ulcerative colitis, Crohn's disease, and atopic dermatitis.
Etrasimod is an investigational compound that is not approved for any use in any country.
Arena has additional license agreements and partnerships, including with
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be identified by introductory words such as "evaluating", "progressing," "will," "advancing," "potential," "initiating," "confident that" "look forward to," "designed to," "driven to," "potentially," "being evaluated for," "assess," 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, including regarding its design, its therapeutic potential in immune-mediated inflammatory diseases such as ulcerative colitis, Crohn's disease, and atopic dermatitis, its ability to treat atopic dermatitis, improve lives, and satisfy an unmet medical or clinical need, and its safety and efficacy; the ADVISE trial, including enrollment, study sites, trial design, and timing of Phase 2 data; the significance of the ADVISE trial and its initiation; Arena's drive; and the potential of Arena's assets, programs, licenses, and partnerships, including to be first- or best-in-class or have broad clinical utility. 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; enrolling subjects in our ongoing and intended clinical trials is competitive and challenging; 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; clinical trials and other studies may not proceed at the time or in the manner expected or at all; 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; our drug candidates may not advance in development or be approved for marketing; risks related to 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
Executive Vice President and
Chief Financial Officer
Matt Middleman, MD
LifeSci Public Relations
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