Arena Pharmaceuticals Completes Phase 1b Clinical Trial Evaluating APD811 for Pulmonary Arterial Hypertension -- Preparation for APD811 Phase 2 Clinical Trial Now Underway --
SAN DIEGO, Aug. 28, 2013 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced the completion of a Phase 1b clinical trial for APD811, an investigational oral prostacyclin (IP) receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). The company plans to initiate a Phase 2 clinical trial for APD811 in the first quarter of 2014.
"Arena's internal GPCR-focused efforts led to the discovery of this novel drug candidate," said William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer. "We believe APD811 is a promising new chemical entity that could improve current patient care by providing an oral option for IP-targeted therapy. Based on the encouraging Phase 1 results, we look forward to initiating the Phase 2 program early next year."
This randomized, double-blind and placebo-controlled Phase 1b clinical trial evaluated the safety, tolerability and pharmacokinetics of multiple-ascending doses of APD811. Arena previously evaluated single-ascending doses of APD811 in a Phase 1a clinical trial.
In the Phase 1b clinical trial, 40 healthy volunteers received APD811 and 15 received placebo, and the safety profile of APD811 was characteristic of IP receptor agonists. No serious adverse events were observed, and the most frequent treatment-emergent adverse events were headache, nausea and jaw pain. The results of the Phase 1 program led to the decision to proceed with Phase 2 development of APD811, which will include further exploration of dosing regimens in PAH patients.
About Pulmonary Arterial Hypertension (PAH)
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.
APD811, an orally available agonist of the prostacyclin (IP) receptor, is an investigational drug candidate internally discovered and developed by Arena and intended for the treatment of PAH. Treatment with IP agonists, which can slow disease progression and improve exercise tolerance in PAH patients, is considered standard of care for advanced PAH. Currently available IP agonists belong to the prostanoid class of molecules, and these products need to be administered frequently or continuously through intravenous, subcutaneous or inhaled delivery methods. Arena believes that an orally available, non-prostanoid IP agonist such as APD811 may have the potential to improve the standard of care for PAH.
About Arena Pharmaceuticals
Arena is a biopharmaceutical company focused on discovering, developing and commercializing novel drugs that target G protein-coupled receptors, or GPCRs, to address unmet medical needs. BELVIQ® (lorcaserin HCl), Arena's internally discovered drug, is approved in the United States, and is under review for regulatory approval in additional territories. 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.
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, therapeutic indication, safety, efficacy and mechanism of action of APD811; the initiation of a Phase 2 clinical trial for APD811 and the further exploration of dosing regimens; the potential of APD811 and orally available, non-prostanoid IP agonists in general, including in improving patient care; the regulatory review and approval of BELVIQ; and Arena's focus, plans, goals, strategy, 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: APD811 may not be sufficient for further development or regulatory review or approval; risks related to commercializing drugs, including regulatory, manufacturing and supply 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 further research and development, regulatory review or approval or continued marketing; Arena's ability to obtain and defend patents; 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.
SOURCE Arena Pharmaceuticals, Inc.