Cytochroma has announced the positive results from the Phase 2b clinical trial of its drug product, CTAP101 capsules, used for the treatment of patients with secondary hyperparathyroidism (SHPT), stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
CTAP101 is a first-in-class treatment that is designed to reliably correct vitamin D insufficiency by increasing serum vitamin D pro-hormone (25D) concentrations to adequate levels and controlling elevated plasma intact parathyroid hormone (iPTH).
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The Phase 2b study was a randomised, double-blind, placebo-controlled study that enrolled 78 subjects with SHPT, stage 3 or 4 CKD and vitamin D insufficiency across 17 sites in the US.
In the study, subjects were treated daily with one of three doses of CTAP101 capsules (30mcg, 60mcg, or 90mcg) or a matching placebo for six weeks and monitored for serum total 25-hydroxyvitamin D (25D), plasma iPTH and serum calcium and phosphorus levels.
CTAP101 capsules increased serum total 25D and reduced plasma iPTH by =30% from pre-treatment baseline in 39%, 65% and 63% of intent-to-treat subjects treated with doses of 30mcg, 60mcg and 90mcg, respectively.
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Cytochroma president and CEO Charles Bishop said CTAP101 capsules performed well above the company’s expectations in the Phase 2b study.
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By GlobalData"No marketed therapy both effectively controls elevated serum parathyroid hormone levels and corrects the underlying vitamin D insufficiency in CKD patients," Bishop added.
"These strong data indicate that CTAP101 capsules are a highly differentiated product compared to current treatment options. We look forward to initiating Phase 3 trials later in 2012."
CKD, a progressive loss in renal function, affects over 26 million people in the US, including more than eight million patients with moderate (stages 3 and 4) CKD, according to the National Kidney Foundation.
SHPT is a condition in which the parathyroid glands secrete excessive amounts of PTH into the blood due to renal and/or vitamin D insufficiency, leading to elevated serum calcium and phosphorus levels.
