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news.Cytochroma has initiated a phase III study of its vitamin D prohormone capsules, CTAP101, designed for the treatment of secondary hyperparathyroidism (SHPT), stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
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Proprietary modified-release CTAP101 capsules are designed to raise prohormone serum total 25-hydroxyvitamin D concentrations to targeted levels (at least 30 ng/mL), while avoiding upregulation of a cytochrome P-450 enzyme that reduces the PTH-lowering potency of current vitamin D supplements.
Changes in serum calcium, serum phosphorus and plasma intact parathyroid hormone levels, vitamin D status, adverse events, physical and clinical laboratory assessments are the endpoints for the randomized, double-blind, placebo controlled, multi-site parallel studies.
Cytochroma clinical research and development vice president Joel Z Melnick said secondary hyperparathyroidism develops in CKD patients due to vitamin D insufficiency or declining kidney function.
"Most CKD patients have insufficient stores of vitamin D due to the abnormal upregulation of CYP24, an enzyme which specifically destroys vitamin D and its metabolites," Melnick added.
"Many recent studies in CKD patients have demonstrated that over-the-counter and prescription vitamin D supplements cannot reliably raise blood vitamin D prohormone levels or effectively treat SHPT.
"In contrast, our phase II b trial has demonstrated that CTAP101 Capsules effectively and safely treat both SHPT and the underlying vitamin D insufficiency."