SAN DIEGO, Dec. 7, 2016 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that it has completed enrollment in the ralinepag phase 2 trial. Ralinepag is an oral, selective IP receptor agonist targeting the prostacyclin pathway for the treatment of pulmonary arterial hypertension (PAH). The study enrolled approximately 60 patients at sites globally.
"This marks an important step in the development of ralinepag and is evidence of our strategic focus on our pipeline," said Amit Munshi, Arena's President and CEO. "We believe ralinepag has the potential to achieve a best-in-class profile for patients suffering from PAH and we look forward to seeing the results mid-year to confirm our hypothesis."
The trial is a 22-week, randomized, double-blind, placebo-controlled Phase 2 trial evaluating the effectiveness in reducing pulmonary vascular resistance, improving exercise capacity, tolerability and safety of ralinepag.
Pulmonary arterial hypertension (PAH) is a rare, 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.
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 ralinepag's high intrinsic potency and activity at the human IP receptor 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
We are a biopharmaceutical company focused on developing novel, small molecule drugs across a range of therapeutic areas. We have three primary proprietary investigational clinical programs: etrasimod (APD334) in Phase 2 evaluation for ulcerative colitis, APD371 entering Phase 2 evaluation for the treatment of pain associated with Crohn's disease, and ralinepag (APD811) in Phase 2 evaluation for pulmonary arterial hypertension (PAH). Additionally, we have collaborations with the following pharmaceutical companies: Eisai Co., Ltd. and Eisai Inc. (commercial stage), Axovant Sciences Ltd. (Phase 2 candidate), and Boehringer Ingelheim International GmbH (preclinical candidate).
Our US operations are located in San Diego, California. Our primary clinical operations are located in Zug, Switzerland, and our commercial manufacturing for BELVIQ is located in Zofingen, Switzerland.
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 ongoing Phase 2 program for ralinepag; the expected timing of clinical data; whether planned clinical trials for ralinepag can be completed; the improved treatment of patients with PAH; the advancement and potential of Arena's clinical programs; and Arena's focus, primary programs and collaborations. 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 those 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.
Kevin R. Lind, Chief Financial Officer [email protected]
SOURCE Arena Pharmaceuticals, Inc.