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Arena Pharmaceuticals to Present Data from the Phase 2b ADVISE Trial - Late-Breaker at Revolutionizing Atopic Dermatitis Conference

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Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced the presentation of topline results from the Phase 2b ADVISE trial for etrasimod, a novel oral treatment for moderate-to-severe atopic dermatitis, at the Revolutionizing Atopic Dermatitis (RAD) 2020 Virtual Conference. The findings support etrasimod's potential as an effective once-daily therapy. Etrasimod is designed for various immune-mediated diseases but remains investigational and unapproved.

Positive
  • Topline results from the Phase 2b ADVISE trial support etrasimod as a potential oral therapy for atopic dermatitis.
  • Etrasimod is designed for optimized pharmacology targeting multiple immune-mediated inflammatory diseases.
Negative
  • Etrasimod is still an investigational compound and has not received approval in any country.

SAN DIEGO, Dec. 11, 2020 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that data from the Phase 2b ADVISE trial evaluating the safety and efficacy of etrasimod, a highly selective, once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator, in participants with moderate-to-severe atopic dermatitis (AD), will be presented at the Revolutionizing Atopic Dermatitis (RAD) 2020 Virtual Conference.

"I am pleased to present the topline results from the ADVISE Phase 2 trial which support the rationale for etrasimod as a potential oral, once-daily therapy with a novel mechanism of action for the treatment of atopic dermatitis. I look forward to seeing the advancement of etrasimod to the next phase of clinical development," stated Robert Bissonnette, MD, FRCPC, Founder and CEO, Innovaderm Research. "There is a significant unmet clinical need for the development of novel oral therapeutic options for atopic dermatitis patients."

Title: Results from ADVISE: a randomized, double-blind, placebo-controlled Phase 2 study of etrasimod, an oral, selective, sphingosine 1-phosphate receptor modulator, in adults with moderate-to-severe atopic dermatitis
Presenter: Dr. Robert Bissonnette
Authors: Jonathan Silverberg, Robert Bissonnette, Leon Kircik, Dedee Murrell, Andrew Selfridge, Gurpreet Ahluwalia, Kris Liu, Emma Guttman-Yassky
Date/Time: 8:50 – 8:57 AM ET, Monday, December 14, 2020
Session: Late-Breaking Research Session

About Etrasimod
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 is intended to provide 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, eosinophilic esophagitis, atopic dermatitis, and alopecia areata.

Etrasimod is an investigational compound that is not approved for any use in any country.

About Arena Pharmaceuticals
ARENA Pharmaceuticals is a team with a singular purpose – deliver our important medicines to patients.

In a rapidly changing global market, we work with a sense of urgency every day to understand the needs of all our stakeholders, identify bold, sometimes disruptive, ideas to get our medicines to patients, and relentlessly execute until it's done.

ARENA - Care More. Act Differently.

Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements may be identified by words such as "evaluating," "potential," "may," "will," and "designed for," and "intended to" and include, without limitation, statements about the following: the topline results from the ADVISE Phase 2 clinical trial supporting the rationale for etrasimod as a potential oral, once-daily therapy with a novel mechanism of action for the treatment of atopic dermatitis; the opportunity, development and potential of etrasimod, its therapeutic potential in immune-mediated inflammatory diseases such as atopic dermatitis, its ability to satisfy an unmet medical or clinical need, its potential effects, and its selectivity, safety, and activity; and Arena's purpose, work, understanding, ideas, and execution. 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, but are not limited to, the following: clinical trials and other studies may not proceed at the time or in the manner expected, or at all; the timing and outcome of research, development and regulatory review is uncertain, and Arena's drug candidates may not advance in development or be approved for marketing; the duration and severity of the COVID-19 pandemic, including but not limited to its impact on Arena's clinical trials and operations, the operations of Arena's suppliers, partners, collaborators, licensees, and the capital markets, which in each case remains uncertain; risks related to developing and commercializing drugs; Arena may need additional funds to advance all of its programs; risks and uncertainties relating to cash and revenues that may be generated from product sales or other sources, including the impact of competition; risks related to unexpected or unfavorable new data; nonclinical and clinical data is 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; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; topline data may not accurately reflect the complete results of a particular study or trial; satisfactory resolution of litigation or other disagreements with others; government and third-party payor actions, including relating to reimbursement and pricing; risks related to relying on licenses or collaborative arrangements, including lack of control and potential disputes; the entry into or modification or termination of licenses or collaborative arrangements; and Arena's and third parties' intellectual property rights. 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 Arena's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the SEC on November 9, 2020. 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 Contacts:
Patrick Malloy
Arena Pharmaceuticals, Inc.
Vice President, Investor Relations & Corporate Communications
pmalloy@arenapharm.com
847.987.4878

Megan E. Knight
Arena Pharmaceuticals, Inc.
Director, Investor Relations 
mknight@arenapharm.com
858.210.3635

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SOURCE Arena Pharmaceuticals, Inc.

FAQ

What are the results of the Phase 2b ADVISE trial for ARNA's etrasimod?

The Phase 2b ADVISE trial results support etrasimod as a potential oral treatment for moderate-to-severe atopic dermatitis.

When will the results of the ADVISE trial be presented?

The topline results will be presented on December 14, 2020, at the RAD 2020 Virtual Conference.

What diseases could etrasimod potentially treat?

Etrasimod may treat various immune-mediated inflammatory diseases including atopic dermatitis, ulcerative colitis, and Crohn's disease.

Is etrasimod approved for use?

No, etrasimod is an investigational compound and is not approved for any use in any country.

What is the significance of the ADVISE trial for ARNA's stock?

The ADVISE trial results may enhance investor confidence in etrasimod's market potential, influencing ARNA's stock positively.

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