Positive results from Cytochroma CTAP101 Phase 2b clinical trial for CKD

May 11 2012

Cytochroma today announced positive clinical trial results for its lead product, CTAP101 Capsules.  In a recently completed Phase 2b trial, CTAP101 Capsules effectively and safely lowered elevated plasma intact parathyroid hormone (iPTH) in patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.  These findings, as well as two other presentations on CTAP101 Capsules, are being featured at the National Kidney Foundation (NKF) 2012 Spring Clinical Meetings in Washington, DC taking place from May 9-13, 2012.

"CTAP101 Capsules performed well above our expectations in the Phase 2b study," stated Dr. Charles W. Bishop, President and CEO of Cytochroma.  "No marketed therapy both effectively controls elevated serum parathyroid hormone levels and corrects the underlying vitamin D insufficiency in CKD patients. These strong data indicate that CTAP101 Capsules is a highly differentiated product compared to current treatment options.  We look forward to initiating Phase 3 trials later this year."

The Phase 2b study was a randomized, double-blind, placebo-controlled evaluation of 78 subjects with secondary hyperparathyroidism (SHPT), stage 3 or 4 CKD and vitamin D insufficiency.  Subjects were recruited from 17 sites in the United States (US) and treated daily with one of three doses of CTAP101 Capsules (30, 60, or 90 mcg) or a matching placebo for 6 weeks. During treatment, serum total 25-hydroxyvitamin D (25D), plasma iPTH, serum calcium and serum phosphorus were monitored at least weekly. CTAP101 Capsules increased serum total 25D and reduced plasma iPTH significantly, in a dose-proportional manner compared to placebo therapy.  Low serum total 25D was corrected to adequate levels (≥30 ng/mL) in nearly every treated subject. Plasma iPTH was reduced by ≥30% from pre-treatment baseline in 39%, 65%, and 63% of intent-to-treat subjects treated with doses of 30, 60, and 90 mcg, respectively (p-values < 0.05).  CTAP101 Capsules had no adverse effects on serum calcium, serum phosphorus, or urine calcium throughout the 6-week treatment period, or the 6-week follow-up period.  The presentation of this study at the NKF 2012 Spring Clinical Meetings occurred under abstract #97, titled "CTAP101 Capsules Significantly Increases Serum 25D and Lowers Plasma iPTH Levels in Stage 3 and 4 CKD Patients".

Two other presentations appearing at the NKF 2012 Spring Clinical Meetings will be:

• Abstract #96, titled "CKD Patients May Require Higher Serum Total 25D Levels to Normalize Elevated iPTH"
• Abstract #91, titled "Gradual vs. Rapid Repletion of D Deficient Rats"