OPKO Finishes Patient Recruitment In Second Phase 3 Study Of Rayaldy

(RTTNews) - OPKO Health, Inc. (OPK), Thursday said it completed patient recruitment in the second phase 3 trial of Rayaldy for patients with secondary hyperparathyroidism or SHPT, stage 3 or 4 chronic kidney disease, and vitamin D insufficiency.

This trial is the second of the two studies planned to establish the safety and efficacy of Rayaldy as a new treatment for SHPT in the targeted population. The endpoints of both studies include vitamin D status and changes in serum calcium, serum phosphorus and plasma intact parathyroid hormone.

Each of the phase 3 trials involves about 210 patients recruited at nearly 40 sites in the United States. Top-line data from both trials are expected in mid-2014. The two pivotal trials are being followed by an open-label extension study in which patients are treated, at their election, for an additional 6 months with Rayaldy. More than 50% of the required patients have enrolled in this open-label study and some have already completed treatment.