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OPKO Health, Inc.
has entered into a definitive agreement to
acquire Cytochroma Inc. (Markham, Canada) whose lead products, both in phase 3
clinical trials, are Replidea™ (coded CTAP101 Capsules), a vitamin D
prohormone to treat secondary hyperparathyroidism (SHPT) in patients with
stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency, and
Alpharen™, a non-absorbed phosphate binder to treat hyperphosphatemia in
dialysis patients.
Replidea™ has been shown in a phase 2b clinical trial to effectively and
safely treat SHPT and the underlying vitamin D insufficiency in pre-dialysis
patients. Vitamin D insufficiency arises in CKD due to the abnormal
upregulation of CYP24, an enzyme which destroys vitamin D and its metabolites.
Studies in CKD patients have demonstrated that currently available
over-the-counter and prescription vitamin D products cannot reliably raise
blood vitamin D prohormone levels or effectively treat SHPT.
“OPKO intends to market Replidea™ along with our proprietary point-of-care
vitamin D diagnostic test currently in development,” stated Phillip Frost, MD,
CEO and Chairman. “We envision these remarkable products as part of the
foundation for a new and markedly improved standard of care for chronic kidney
disease patients having SHPT and/or hyperphosphatemia.”
Alpharen™ has been shown safe and effective in treating hyperphosphatemia in
the phase 2 and 3 clinical trials undertaken to date in dialysis patients.
Hyperphosphatemia (elevated serum phosphorus) exacerbates SHPT and promotes
bone disease, soft tissue mineralization and progression of kidney disease.
Approximately 90% of dialysis patients in the United States require regular
treatment.
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