Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that it has achieved target enrollment in Study A of the Phase 2/3 CULTIVATE 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 Crohn's disease (CD). CULTIVATE Study A reached target enrollment of 70 study participants to assess etrasimod 2 mg and 3 mg in participants with CD.
"Crohn's disease patients have an intense need for additional therapeutic options, particularly for a safe and effective oral option," said Doug Manion, MD, FRCP (C) Executive Vice President, Research & Development at Arena. "We are already progressing etrasimod into the next study in the CULTIVATE program and look forward to seeing the topline data from Study A in Q2 2022."
About CULTIVATE and Study A
CULTIVATE is a Phase 2/3 trial consisting of five studies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderate to severe Crohn's disease (CD) who are refractory or intolerant to at least one of the current therapies for CD. CULTIVATE is being conducted in approximately 27 countries globally.
CULTIVATE Study A is a Phase 2 randomized, double-blind trial to assess the efficacy, safety, and tolerability of etrasimod 2 mg and 3 mg once-daily in participants with moderate to severe CD to support the selection of an induction and maintenance dose(s) for Phase 3. Study A consists of a 14-week induction and a 52-week extension period. The primary outcome measures is number and severity of adverse events. Key secondary measures include efficacy as measured by the Simple Endoscopic Score in CD (SES-CD) and the Crohn's Disease Activity Index (CDAI).
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 receptors 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 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 medicines to patients, and relentlessly execute until it's done.
We are developing a richly diversified portfolio of therapeutic candidates targeting gastroenterology, dermatology and cardiology. To fuel our growth, we are unlocking the value of our historical GPCR research with a sustainable discovery engine for broad portfolio expansion.
ARENA - Care More. Act Differently.
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 "on track," “designed to,” “expect,” “may,” “lead to,” and “potentially,” and include, without limitation, statements about the potential benefits of the CULTIVATE trial, the timing of topline data from CULTIVATE Study A, the potential benefits of etrasimod, 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 and the operations of Arena’s suppliers, partners, collaborators, licensees, which in each case remains uncertain; risks related to developing and commercializing drugs; 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; 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 under the heading “Risk Factors” in Arena’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the SEC on November 4, 2021. 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.
Arena Pharmaceuticals, Inc.
Vice President, Investor Relations & Corporate Communications