Arena Pharmaceuticals Initiates Phase 2 Clinical Trial Evaluating Ralinepag for Pulmonary Arterial Hypertension

Press Release

Arena Pharmaceuticals Initiates Phase 2 Clinical Trial Evaluating Ralinepag for Pulmonary Arterial Hypertension

SAN DIEGO, Jan. 12, 2015 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the initiation of patient dosing in a Phase 2 clinical trial of ralinepag, an oral, non-prostanoid prostacyclin (IP) receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH).

"An intriguing component of this compound is the smooth peak-to-trough ratio, which may potentiate efficacy and minimize toxicity relative to currently available therapies," said Lewis J. Rubin, M.D., Emeritus Professor of Medicine at University of California, San Diego, School of Medicine. "This clinical trial should help to further elucidate how ralinepag's intrinsic properties translate to its efficacy and safety profile."

This 22-week, randomized, double-blind and placebo-controlled Phase 2 trial will evaluate the hemodynamic and exercise capacity effects, safety and tolerability of ralinepag in up to 60 patients with PAH. During the first nine weeks of the trial, patients will be titrated to their individual tolerance level, and then sustained at this level for the remainder of the trial.

"We believe ralinepag offers promise in the IP receptor class of molecules given its oral availability, long plasma half-life, and high selectivity and potency in vitro," said Jack Lief, Arena's President and Chief Executive Officer. "In conjunction with our other clinical-stage programs, this compound further enhances our optimism about Arena's value drivers."

About Pulmonary Arterial Hypertension

PAH is a progressive, life-threatening disorder characterized by increased pressure in the arteries that carry blood from the heart to the lungs. The increased pressure strains the heart, which can limit physical activity, result in heart failure and reduce life expectancy. Based on data from the Registry to EValuate Early And Long-term PAH disease management (REVEAL) of patients in the United States, there is an estimated five-year survival rate of 57% from diagnosis.

About Ralinepag

Ralinepag, an orally available agonist of the IP receptor, is an investigational drug candidate internally discovered and developed by Arena and intended for the treatment of vascular diseases, including PAH. In Phase 1 trials, ralinepag showed an approximate 25-hour half-life, indicating that the compound could be dosed once or twice daily. Arena believes that an orally available, non-prostanoid IP receptor agonist that provides clinical benefits similar to currently available IP receptor agonists has the potential to improve treatment for patients with PAH. The FDA has granted ralinepag orphan drug status for the treatment of PAH.

About Arena Pharmaceuticals

Arena is embracing the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena's internally discovered drug, BELVIQ® (lorcaserin HCl), is approved in the United States, and Arena is focused on discovering, developing and commercializing additional drugs to address unmet medical needs. Arena's US operations are located in San Diego, California, and its operations outside of the United States, including its commercial manufacturing facility, are located in Zofingen, Switzerland. For more information, visit Arena's website at www.arenapharm.com.

Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.

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 include statements about the advancement, evaluation, therapeutic indication, use, safety, efficacy, dosing, mechanism of action, significance and potential of ralinepag, including relative to other therapies; the protocol, design, scope, enrollment, expectations and other aspects of the Phase 2 clinical trial of ralinepag, including with respect to ralinepag's properties and efficacy and safety profile; value drivers; potential of an orally available, non-prostanoid IP receptor agonist that provides clinical benefits similar to available IP receptor agonists; embracing the challenge of improving health; seeking to bring innovative medicines to patients; and Arena's focus, plans, goals, strategy, optimism, expectations, research and development programs, and ability to discover and develop compounds and commercialize drugs. 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: ralinepag may not be developed, approved for marketing or commercialized for any disease or condition; risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing issues and the availability and use of BELVIQ; cash and revenues generated from BELVIQ, including the impact of competition; Arena's revenues will be based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena's guidance or previously reported results; the timing and outcome of regulatory review is uncertain, and BELVIQ may not be approved for marketing when expected or ever in combination with another drug, for another indication or using a different formulation or in any other territory for any indication; regulatory decisions in one territory may impact other regulatory decisions and Arena's business prospects; government and commercial reimbursement and pricing decisions; risks related to relying on collaborative arrangements; the timing and receipt of payments and fees, if any, from collaborators; the entry into or modification or termination of collaborative arrangements; 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; data and other information related to any of Arena's research and development may not meet regulatory requirements or otherwise be sufficient for (or Arena or a collaborator may not pursue) further research and development, regulatory review or approval or continued marketing; Arena's and third parties' intellectual property rights; the timing, success and cost of Arena's research and development; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; having adequate funds; 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. 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.

Contact: Arena Pharmaceuticals, Inc.

Media Contact: Russo Partners



Craig M. Audet, Ph.D., Senior Vice President,

David Schull, President

Operations & Head of Global Regulatory Affairs 

david.schull@russopartnersllc.com

caudet@arenapharm.com  

858.717.2310

858.453.7200, ext. 1612




www.arenapharm.com


 

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SOURCE Arena Pharmaceuticals, Inc.

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