Significant improvement in pulmonary vascular resistance (PVR) with ralinepag compared to placebo
SAN DIEGO, Oct. 19, 2017 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (ARNA) today announced that results of the Phase 2 clinical study of ralinepag (APD811), the Company's next-generation, oral, selective prostacyclin receptor (IP) agonist, intended for the treatment of pulmonary arterial hypertension (PAH), will be presented at the American College of Chest Physicians 2017 (CHEST) Annual Meeting, taking place October 28 – November 1 at the Metro Toronto Convention Centre in Toronto, Canada.
Title: Hemodynamic Effects of the Oral Prostacyclin (IP) Receptor Agonist Ralinepag in Pulmonary Arterial Hypertension (PAH)
Session: 4060 - Late-breaking Abstracts 2
Date/Time: Wednesday, November 1st, 3:45 p.m. - 4:00 p.m. EDT
Location: Convention Center - 603
"These Phase 2 results are extremely compelling, particularly considering the contemporary patient population of our trial in which 65% patients were already receiving dual background therapies and all patients were receiving at least one therapy," said Preston Klassen, M.D., MHS, Executive Vice President, Research and Development and Chief Medical Officer of Arena. "We look forward to our upcoming discussions with the FDA and advancing into a Phase 3 clinical program."
Prostacyclin deficiency results in increased pulmonary vascular resistance and is a key factor contributing to disease progression in PAH ultimately leading to right ventricular failure and death if untreated. Drugs targeting the prostacyclin receptor should be considered a cornerstone of optimal PAH therapy as they address a central pathophysiologic mechanism of the disease. Earlier and broader use of parenteral and oral prostacyclin analogues have been limited by inconvenient modes of administration, poor tolerability and sub-optimal pharmacokinetics. Ralinepag was strategically designed in an effort to overcome many of these limitations.
The primary efficacy analysis in the Phase 2 study demonstrated a statistically significant absolute change from baseline in pulmonary vascular resistance (PVR) with ralinepag compared to placebo. Ralinepag also demonstrated a numerical improvement in 6-minute walk distance (6MWD). Adverse events observed in the study were consistent with other prostacyclin receptor agonists used for the management of PAH.
The ralinepag Phase 2 study was a randomized, double-blind, placebo-controlled, dose-ranging study in 61 adult patients with PAH, WHO/NYHA functional class II-IV. Study medication was titrated over 9 weeks, followed by a 13-week treatment period. The primary efficacy analysis was absolute change from baseline in pulmonary vascular resistance (PVR) at week 22. Additional endpoints included change from baseline in 6MWD, proportion of subjects who exhibit clinical worsening and safety and tolerability. Patients who completed week 22 could transition to an open-label ralinepag extension study.
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 the American College of Chest Physicians
The American College of Chest Physicians is the global leader in advancing best patient outcomes through innovative chest medicine education, clinical research, and team-based care. With more than 19,000 members representing 100+ countries around the world, its mission is to champion the prevention, diagnosis, and treatment of chest diseases through education, communication, and research. This includes connecting health-care professionals to the latest clinical research and a wide array of evidence-based guidelines through the CHEST Journal, while also serving as a total education resource for clinicians through year-round meetings, books, mobile apps, and live courses in pulmonary, critical care, and sleep medicine. The first medical association with a clinical simulation program accredited by the Society for Simulation in Healthcare, the American College of Chest Physicians also provides hands-on training through innovative simulation education. The CHEST Foundation, its philanthropic arm, provides members with grants, patient education tools, and other resources to help their patients live and breathe easier.
About Arena Pharmaceuticals
Arena Pharmaceuticals is a biopharmaceutical company focused on developing novel, small molecule drugs with optimized receptor pharmacology designed to deliver broad clinical utility across multiple therapeutic areas. Our proprietary pipeline includes potentially first- or best-in-class programs for which we own global commercial rights. Our three most advanced investigational clinical programs are ralinepag (APD811) which has completed a Phase 2 trial for pulmonary arterial hypertension (PAH), etrasimod (APD334) in Phase 2 evaluation for multiple autoimmune indications, and APD371 in Phase 2 evaluation for the treatment of pain associated with Crohn's disease. In addition, Arena has collaborations with the following pharmaceutical companies: Eisai Co., Ltd. and Eisai Inc. (commercial stage), Axovant Sciences (Phase 2 candidate), and Boehringer Ingelheim International GmbH (preclinical candidate).
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by introductory words such as "will," "look forward to," "upcoming," "intended," "potentially," "designed to," or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include statements about the upcoming presentation of ralinepag data, future discussions with the FDA, plans for a Phase 3 trial of ralinepag, the use of drugs targeting the prostacyclin receptor, our focus, and the potential of ralinepag and our other programs and collaborations. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from our expectations. Factors that could cause actual results to differ materially from the forward-looking statements include: topline data may not accurately reflect the complete results of a particular study or trial; 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; the timing and outcome of research, development and regulatory review is uncertain; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; we expect to need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; our drug candidates may not advance in development or be approved for marketing; risks related to developing and commercializing drugs; our revenues are based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to our guidance or previously reported results; government and third-party payor actions, including relating to reimbursement and pricing; risks related to relying on collaborative arrangements; the entry into or modification or termination of collaborative arrangements; unexpected or unfavorable new data; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than us or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; our and third parties' intellectual property rights; satisfactory resolution of litigation or other disagreements with others; and those factors disclosed in our filings with the Securities and Exchange Commission, including our Form 10-Q for the quarter ended June 30, 2017. These forward-looking statements represent our judgment as the time of this release. We disclaim any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
Matt Middleman, M.D.
LifeSci Public Relations
View original content:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-announces-late-breaking-presentation-of-positive-phase-2-results-with-ralinepag-in-patients-with-pulmonary-arterial-hypertension-at-the-american-college-of-chest-physicians-2017-annual-meeting-300539549.html