SAN DIEGO, CA, USA I August 28, 2018 I 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.”
Presentation Details
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
About Ralinepag
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).
SOURCE: Arena Pharmaceuticals
Post Views: 52
SAN DIEGO, CA, USA I August 28, 2018 I 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.”
Presentation Details
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
About Ralinepag
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).
SOURCE: Arena Pharmaceuticals
Post Views: 52
