Arena Pharmaceuticals Announces Phase 2 Data Presentation for Ralinepag in Pulmonary Arterial Hypertension at the International Society for Heart and Lung Transplantation Annual Meeting
"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.
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
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.
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 "will," "potential," "look forward to," "intended for," "potentially," "focused on," "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, without limitation, statements about Arena's upcoming presentation at the ISHLT Annual Meeting; ralinepag, including relating to its potential to be an effective PAH treatment or best-in-class, the Phase 3 clinical program in patients with PAH that is currently in development and potential findings from that study; and Arena's programs (including their first- or best-in-class potential), focus 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; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; the timing and outcome of research, development and regulatory review is uncertain; topline data may not accurately reflect the complete results of a particular study or trial; 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 Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; risks related to unexpected or unfavorable new data; and risks related to developing and commercializing drugs. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the
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