"We are pleased to move Oral CR845 forward into non-hemodialysis patients with earlier-stage CKD," said
Phase 1 Trial Design
The Phase 1 trial is designed to examine the pharmacokinetics and safety of three tablet strengths of Oral CR845 (0.25 mg, 0.5 mg and 1.0 mg), dosed daily over a one-week treatment period in up to 80 non-hemodialysis patients with stage III-V
CKD. Data from this trial will inform dose selection and design of a planned placebo-controlled Phase 2 trial of Oral CR845 in non-hemodialysis stage III-V CKD-aP patients, which the Company plans to initiate in the first quarter of 2018. The
CKD-aP is an intractable systemic itch condition that occurs with the greatest frequency and intensity in patients with chronic kidney disease undergoing hemodialysis and peritoneal dialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis. Recent data from the ITCH National Registry Study showed that among those with pruritus, 59 percent experienced symptoms daily or nearly daily for more than a year. Given its association with CKD/ESRD, most afflicted patients will continue to have symptoms for months or years with currently employed antipruritic treatments, such as antihistamines and corticosteroids, unable to provide consistent adequate relief. Moderate-to-severe chronic pruritus has repeatedly been shown to directly decrease quality of life, contribute to symptoms that impair quality of life (such as poor sleep quality), and is associated with depression. CKD-aP is also an independent predictor of mortality among hemodialysis patients, mainly related to increased risk of inflammation and infections.
Center for Disease Control and Prevention: Chronic Kidney Disease (CKD) Surveillance Project. National Health and Nutrition Examination Survey. 2014.
- Pruritus in Chronic Kidney Disease Patients: Early Results from CKDOPPS. Sukul, et. al, ERA-EDTA Abstract.
- IMS Pruritus Market Landscape Analysis.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning Oral CR845's potential as a treatment for CKD-aP in patients with stage III-V CKD and statements concerning the timing of
the initiation of the Company's planned Phase 2 trial of Oral CR845 for the treatment of CKD‑aP in stage III-V CKD patients. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in
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