Cytochroma today announced the
initiation of a phase 3 study of CTAP101 capsules ("CTAP101 Capsules")
in patients with secondary hyperparathyroidism (SHPT), stage 3 or 4
chronic kidney disease (CKD) and vitamin D insufficiency. The newly
initiated trial is the first of two identical randomized, double-blind,
placebo controlled, multi-site studies intended to establish the safety
and efficacy of CTAP101 Capsules as a new treatment for SHPT in the
targeted population. The endpoints of both studies, which will be
conducted in parallel, include vitamin D status, adverse events,
physical and clinical laboratory assessments, and changes in serum
calcium, serum phosphorus and plasma intact parathyroid hormone (PTH).
"Secondary hyperparathyroidism develops in CKD patients due to vitamin D
insufficiency or declining kidney function," explained Joel Z. Melnick,
M.D., Cytochroma's Vice President, Clinical Research and Development.
"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. 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 2b trial has
demonstrated that CTAP101 Capsules effectively and safely treat both
SHPT and the underlying vitamin D insufficiency."
The ongoing phase 3 trial will involve 210 patients recruited from
approximately 30 sites in the United States (US). These patients will
be stratified by CKD stage and randomized in a 2:1 fashion to receive
six months of treatment with either CTAP101 Capsules or matching
placebo. Dosing with CTAP101 Capsules will start at 30 mcg/day and be
titrated, as necessary, to achieve the desired drug concentration in
the blood and the targeted reduction in plasma PTH.
"CTAP101 Capsules are being developed as a much needed and safer
alternative to currently used activated vitamin D hormones," commented
Dr. David Bushinsky, Chief of Nephrology at the University of
Rochester. "Activated vitamin D hormone therapy is problematic in CKD
patients with secondary hyperparathyroidism arising primarily from
vitamin D insufficiency since it further stimulates catabolism of the
available vitamin D stores and is often associated with hypercalcemia,
a side effect linked to vascular calcification."
The phase 3 program will be funded, in part, by committed financings of
nearly $CDN 32 million of which the first two stages closed earlier
this year. The lead investors in the financings were Covington Fund II
(Toronto) and Business Development Bank of Canada (Montreal).
Participating investors included the Bombardier Trust (Canada) Funds
(Montreal), Caisse de dépôt et placement du Québec (Québec), Comerica
Bank (Toronto), GrowthWorks (Toronto), MaRS Investment Accelerator Fund
(Toronto), Partners Group (Zug), Roseway Capital Sarl (Luxembourg) and
VentureLink Innovation Fund (Toronto).
"Covington is delighted to support the phase 3 development of CTAP101
Capsules," stated Ms. Lily Lam, VP Investments, Covington and a
director of Cytochroma. "Speaking on behalf of all participants in
these financings, we view CTAP101 Capsules as a well-advanced and low
risk product candidate with high commercial prospects under rapid
development by an experienced management team."
The two identical pivotal Phase 3 trials are covered by a Special
Protocol Assessment granted by the US Food and Drug Administration
(FDA) on August 30, 2012.