Navigation Links
Arena Pharmaceuticals Completes Phase 1b Clinical Trial Evaluating APD811 for Pulmonary Arterial Hypertension
Date:8/28/2013

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.About APD811APD811, 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 PharmaceuticalsArena 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.

Forward-Looking StatementsCertain 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.Contact: Arena Pharmaceuticals, Inc.

Media Contact: Russo PartnersCindy McGee, Vice President,

David Schull, PresidentInvestor Relations & Alliance Management

david.schull@russopartnersllc.comcmcgee@arenapharm.com  

858.717.2310858.453.7200, ext. 1479 www.arenapharm.com 
'/>"/>

SOURCE Arena Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2013 Financial Results
2. Arena Pharmaceuticals to Host Corporate Update and Financial Results Conference Call and Webcast on Thursday, August 1
3. Arena Pharmaceuticals to Present at the 2013 Wells Fargo Securities Healthcare Conference
4. Former Semi-Pro Arena Football Player Bridged to Heart Transplant with the SynCardia Total Artificial Heart
5. Arena Pharmaceuticals to Present at the Bank of America Merrill Lynch 2013 Health Care Conference
6. BIOCOM Applauds Arena Pharmaceuticals Commitment to Innovation, Contributions to Southern California Life Science Community
7. Carena Launches 24/7 Virtual Care Delivery Service for Hospital Systems and Primary Care Clinics
8. Arena Pharmaceuticals Provides Corporate Update and Reports First Quarter 2013 Financial Results
9. Arena Pharmaceuticals to Host Corporate Update and Financial Results Conference Call and Webcast on Thursday, May 2
10. Arena Pharmaceuticals Initiates Phase 1 Clinical Trial of APD334 for Autoimmune Diseases
11. Arena Pharmaceuticals Provides Corporate Update and Reviews Fourth Quarter and Full Year 2012 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... 2016 Open Access Journal ... Elsevier , a world-leading provider of ... announced the launch of Clinical Neurophysiology ... focuses on clinical practice issues in clinical neurophysiology. The ... normal values and didactic reviews. It is an official ...
(Date:5/23/2016)... , May 23, 2016 ... "Patient Handling Equipment Market by Product (Wheelchair, Scooters, ... Care (Bariatric Care, Critical Care, Wound), Accessories (Lifting, ... Forecast to 2021", published by MarketsandMarkets, the patient ... 17.18 Billion by 2021 at a CAGR of ...
(Date:5/23/2016)... 2016 Transparency Market Research has ... Insufficiency Market - Global Industry Analysis, Size, Share, Growth, ... the report, the exocrine pancreatic insufficiency market is anticipated ... to 2023 to reach US$2.85 Bn by 2023. ... by the deficiency of the exocrine pancreatic enzymes, causing ...
Breaking Medicine Technology:
(Date:5/25/2016)... ... 25, 2016 , ... Serenity Recovery, a holistic treatment center ... of the many supplemental program options offered at their rehabilitation facility, this time ... Black Belt in the Shorin-ryu style of Karate that originated in Okinawa, Japan, ...
(Date:5/25/2016)... CA (PRWEB) , ... May 25, 2016 , ... According ... a new type of hernia mesh that would effectively fight against common bacteria and ... could make the healing process from hernia repair surgery even safer and ...
(Date:5/25/2016)... ... ... was a time when tampons and pads were the only options for women for period ... like Lunette . To make that time of the month less of a pain ... video ! , It’s easy to see why Lunette is so popular. Lunette cups ...
(Date:5/25/2016)... NY (PRWEB) , ... May 25, 2016 , ... ... and Florida International University (FIU) Herbert Wertheim College of Medicine announced the AUA-FIU ... Medical Doctor Degree and Global Health Certificate from AUA and a Certificate of ...
(Date:5/25/2016)... ... May 25, 2016 , ... CloudLIMS, joins an elite number of ... Tech Solution Providers list of 2016 by CIOReview. , In a deliberate session with ... Tech Solution Providers 2016 has been concluded with. The positioning is based on evaluation ...
Breaking Medicine News(10 mins):