Additional Phase 3 Data Supporting OPKO's Rayaldee as a Treatment for Secondary Hyperparathyroidism in Chronic Kidney Disease to be Presented at Kidney Week 2015
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE: OPK), a multinational biopharmaceutical and diagnostics company, announces that additional Phase 3 data on Rayaldee™ as a treatment for secondary hyperparathyroidism (SHPT) will be highlighted later today in a poster presentation at Kidney Week 2015, the Annual Meeting of the American Society of Nephrology (ASN) underway in San Diego, California. The data showed that plasma levels of intact parathyroid hormone (iPTH) continued to fall as serum levels of 25-hydroxyvitamin D (25D) rose above 30 ng/mL, a level considered sufficient for CKD patients in published clinical practice guidelines. These data suggest that patients with stage 3 or 4 CKD require higher levels of serum 25D than previously thought in order to control elevated iPTH.
OPKO's poster presentation entitled "Efficacy and Safety of Modified-Release Calcifediol in Stage 3-4 CKD Patients with Secondary Hyperparathyroidism and Vitamin D Insufficiency," will be presented by lead author Stuart M. Sprague, DO, Chief, Division of Nephrology and Hypertension, NorthShore University Health System - University of Chicago, Pritzker School of Medicine.
Session details
Date:Thursday, November 5
Time:10:00 a.m. - 12:00 p.m. Pacific time
Location:San Diego Convention Center, Hall B
Poster:#TH-PO641
About Rayaldee
Rayaldee (calcifediol modified-release capsules) is an oral vitamin D prohormone treatment being developed for SHPT in patients with stage 3 or 4 CKD and vitamin D insufficiency. It has a proprietary modified-release formulation designed to gradually raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) while avoiding upregulation of CYP24A1, a cytochrome P-450 enzyme which interferes with the desired parathyroid hormone (PTH)-lowering effect. Gradual elevation of serum total 25-hydroxyvitamin D is intended to prevent excessive elevation of serum calcium and related vascular and renal calcification.
About Chronic Kidney Disease
CKD is a condition characterized by a progressive decline in kidney function. The kidney is normally responsible for excreting waste and excess water from the body, and for regulating various hormones. CKD is classified in five stages — mild (stage 1) to severe (stage 5) disease — as measured by the kidney's glomerular filtration rate. According to the National Kidney Foundation, CKD afflicts over 26 million people in the U.S., including more than 20 million patients with moderate (stages 3 or 4) and severe (stage 5) forms of CKD. In stage 5 CKD, kidney function is minimal to absent and patients require regular dialysis or a kidney transplant for survival.
About Vitamin D Insufficiency
Vitamin D insufficiency is a condition in which the body has low vitamin D stores, characterized by inadequate blood levels of vitamin D prohormone, known as 25-hydroxyvitamin D. An estimated 70-90% of CKD patients have vitamin D insufficiency, which can lead to SHPT and resultant debilitating bone diseases. Vitamin D insufficiency has been associated with increased mortality in CKD.
About Secondary Hyperparathyroidism (SHPT)
SHPT is a condition commonly associated with CKD in which the parathyroid glands secrete excessive amounts of PTH. SHPT arises as a result of vitamin D insufficiency or impaired kidney function that prevents sufficient production of vitamin D hormone to properly regulate calcium and phosphorus metabolism, and PTH secretion. Prolonged elevation of blood PTH causes excessive calcium and phosphorus to be released from bone, leading to elevated serum calcium and phosphorus, softening of the bones (osteomalacia) and calcification of vascular and renal tissues. SHPT affects 40-60% of patients with moderate CKD and approximately 90% of patients with severe CKD.
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