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Arena Pharmaceuticals Announces Phase 2 Data Presentation for Ralinepag in Pulmonary Arterial Hypertension at the International Society for Heart and Lung Transplantation Annual Meeting

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Friday, April 13, 2018

SAN DIEGO - Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced that data from a post-hoc analysis of the 22-week Phase 2 clinical study for its investigative drug candidate ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension (PAH), will be presented at the International Society for Heart and Lung Transplantation (ISHLT) 2018 Annual Meeting in Nice, France.

Dr. Raymond Benza, Cardiovascular Institute, Allegheny General Hospital, Pittsburgh, will present the results of an analysis assessing the impact of ralinepag treatment on mortality risk, as measured by three risk scoring methodologies (REVEAL, FPHN and COMPERA), in patients on PAH specific background therapy. Registry risk scores are used to identify patients at the highest risk for mortality and assess the impact of treatments on moving patients into a low-risk category.

"Patients receiving ralinepag experienced improvements in their mortality risk category using three risk scoring methodologies developed and utilized globally," said Dr. Benza. "These positive data further highlight the potential of ralinepag as an effective treatment of PAH, and I look forward to determining the impact of ralinepag on clinical outcomes in the Phase 3 clinical program."

Arena previously announced topline Phase 2 results for ralinepag in PAH in which the primary efficacy analysis demonstrated a statistically significant absolute change from baseline in pulmonary vascular resistance compared to placebo. Ralinepag also demonstrated numerical improvement in 6-minute walk distance relative to placebo. Adverse events observed in the study were consistent with other prostacyclin treatments for the management of PAH.

Presentation Details
Title: Ralinepag, An Oral, Selective, Prostacyclin (IP) Receptor Agonist Consistently Improved Mortality Risk Scores Derived From PAH Registries Across Three Regions: Phase 2 Study Analysis

About Ralinepag
Ralinepag (APD811) is an oral, next-generation, selective IP receptor agonist targeting the prostacyclin pathway and intended for the treatment of pulmonary arterial hypertension (PAH). Arena discovered and developed this drug candidate internally. Ralinepag's potency on vasodilation, inhibition of proliferation of vascular smooth muscle cells, and inhibition of platelet aggregation, combined with an extended half-life support its application as a potentially best-in-class agent for the treatment of PAH. Ralinepag is an investigational compound that is not approved for any use in any country.

About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on developing novel, small molecule drugs with optimized receptor pharmacology and pharmacokinetics designed to deliver broad clinical utility across several therapeutic areas. Arena's proprietary pipeline includes potentially first- or best-in-class programs. The most advanced investigational clinical programs are ralinepag (APD811), which will be commencing a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), which will be commencing a Phase 3 program for ulcerative colitis (UC) and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating APD371 in Phase 2 for the treatment of pain associated with Crohn's disease. In addition, Arena has collaborations with the following pharmaceutical companies: Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ - marketed product).

Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and

Chief Financial Officer

Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations

Source: Arena Pharmaceuticals, Inc.
4.0 from 3 votes
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