MARKHAM, ON, Feb. 17 /PRNewswire/ - Cytochroma today announced the initiation of a repeat-dose safety and efficacy study of CTAP101 Capsules in patients with vitamin D insufficiency, secondary hyperparathyroidism (SHPT) and stage 3 chronic kidney disease (CKD).
"Vitamin D insufficiency in CKD patients is a significant problem associated with increased mortality and morbidity and for which no approved treatment is available," stated Joel Z. Melnick, M.D., Cytochroma's Vice President, Clinical Research and Development. "Based on the positive profile observed for CTAP101 Capsules in a previous single-dose Phase 2 study, we have commenced this important repeat-dose study. We are optimistic that this study will demonstrate CTAP101 Capsules to be a more effective and reliable treatment option than currently available vitamin D supplements."
The newly initiated trial is a randomized, double-blind, placebo controlled, multi-site study designed to evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics and tolerability of CTAP101 Capsules, administered at various daily doses, in approximately 60 patients. The endpoints in this study will include vitamin D status, adverse events, physical and clinical laboratory assessments, and changes in serum calcium, phosphorus and intact parathyroid hormone (PTH).
About CTAP101 Capsules
CTAP101 Capsules is being developed as a first-in-class treatment for vitamin D insufficiency and elevated PTH levels in CKD patients. The product is designed to reliably raise serum total vitamin D pro-hormone concentrations to levels of 30 ng/mL or higher, while also lowering the risk of side effects associated with other vitamin D treatments. CTAP101 Capsules is intended to help nephrologists treat and/or prevent SHPT associated with vitamin D insufficiency.
About Chronic Kidney Disease
CKD is a condition characterized by a progressive decline in the function of the kidney, which is normally responsible for excreting waste and excess water from the body, and for regulating various hormones. CKD is classified in five different 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 United States, including more than eight million patients with moderate (stages 3 and 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 blood levels of vitamin D prohormones, collectively 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. Mounting evidence continues to link vitamin D insufficiency with progression of CKD, cardiovascular morbidity, and increased mortality.
About Secondary Hyperparathyroidism (SHPT)
SHPT is a condition commonly associated with CKD in which the parathyroid glands secrete excessive amounts of PTH. Excess PTH secretion arises as a result of impaired kidneys that are unable to produce sufficient quantities of vitamin D hormones to maintain a state of balance (homeostasis) between calcium and phosphorus in the body. Prolonged elevation of PTH causes excessive calcium and phosphorus to be released from bone into the blood, leading to elevated serum calcium and phosphorus, softening of the bones (osteomalacia) and calcification of vascular tissues. SHPT affects 40-60% of patients with moderate CKD and approximately 90% of patients with severe CKD.
Cytochroma is a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary products to treat and prevent the clinical consequences of vitamin D insufficiency and SHPT associated with CKD. The Company specializes in developing new vitamin D therapies which are designed to safely and effectively treat patients with stage 3, 4 or 5 CKD. Cytochroma has three product candidates in clinical development for CKD patients: CTA018 Injection and CTAP201 Injection are being developed for the treatment of SHPT in stage 5 CKD, while CTAP101 Capsules are being developed for the treatment of vitamin D insufficiency and associated SHPT in stage 3 and 4 CKD. Cytochroma also has a portfolio CYP24 and phosphate-uptake inhibitors in early stage development.
For more information about Cytochroma, please visit www.cytochroma.com.