Arena Pharmaceuticals reports 'positive' Phase 2 data for ralinepag
Arena Pharmaceuticals announced positive data from a planned interim analysis of the ongoing open-label extension of the Phase 2 trial of its investigational drug candidate ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension. Patients who continued on ralinepag in the open-label extension had a median treatment duration of 1.8 years at the time of right heart catheterization. In these patients, sustained improvements from baseline in the original study were observed for PVR and 6MWD. Patients switching from placebo to active drug had a median ralinepag treatment duration of 1.4 years at the time of RHC. In these patients, a similar magnitude of improvement was observed for PVR. In both groups, these long-term changes in PVR and 6MWD were observed in a population where the majority of patients were already receiving dual combination PAH background therapy. Adverse events observed in this extension study were consistent with the known profile of prostacyclin therapies for the management of PAH, with headache and nausea being the most commonly reported. Among patients who continued ralinepag in the open-label extension, the incidence rate of AEs was lower relative to the randomized Phase 2 study, suggesting that AEs related to tolerability are reduced after initial drug titration.