Arena Pharmaceuticals Presented Phase 1 Clinical Data for Ralinepag in Pulmonary Arterial Hypertension at the European Society of Cardiology
SAN DIEGO, Aug. 28, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq : ARNA ) today announced that data from two Phase 1 clinical studies evaluating an extended-release (XR) formulation of 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), were presented by Dr. John Adams, PhD at the European Society of Cardiology Congress on August 27.
Data from these Phase 1 clinical studies indicate that the ralinepag XR tablet formulation offers improved pharmacokinetic (PK) performance over selexipag and its active metabolite, MRE-269, by providing an extended effective half-life (28-29 hrs) and maintaining low peak–trough fluctuation with oncedaily dosing.
"With an extended half-life and low peak-to-trough fluctuation, the ralinepag XR tablet closely approximates the PK profile of continuously infused IV-prostacyclin," said Preston Klassen, MD, MHS, Chief Medical Offer of Arena. "These highly favorable and desirable PK characteristics further support the use of the ralinepag XR tablet in the ADVANCE Phase 3 clinical program."
Title: Relative bioavailability and pharmacokinetic (PK) performance of a ralinepag extended-release (XR) tablet oral formulation and the effect of food and gender in healthy human subjects
Abstract number: 3022
Ralinepag (APD811) is a next-generation, oral, selective potent, once-daily IP receptor agonist 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 delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), in a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), expected to commence a Phase 3 program for ulcerative colitis (UC) and a program in Crohn's disease (CD), and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating olorinab (APD371) in a Phase 2 study for the treatment of visceral pain associated with Crohn's disease, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including 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), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as "potentially," "focused on," "expected," or words of similar meaning, or they may be identified by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about the following: the opportunity and potential of etrasimod and ralinepag, including to improve the treatment of patients, to meet unmet medical needs, to deliver broad utility across a range of immune and inflammatory conditions, to be best-in-class, and, in the case of ralinepag, to approximate the pharmacokinetic advantages of continuously infused IV prostacyclin with the ease of a once-daily oral; the ongoing and planned clinical programs for ralinepag and etrasimod, including Arena's ability and timing to initiate, enroll, and complete trials and announce clinical data; and Arena's focus, goals, strategy, clinical 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 that clinical programs may not proceed at the time or in the manner expected or at all, as well as those factors disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which was filed with the SEC on August 7, 2018. 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.
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
Matt Middleman, M.D.
LifeSci Public Relations