"We are very pleased with the productive guidance we have received from the
The End-of-Phase 2 discussion was supported by positive top-line results from an eight-week clinical trial of I.V. CR845 in 174 hemodialysis patients with moderate-to-severe pruritus. The trial met both its primary endpoint, with a 68 percent reduction in worst itching scores versus placebo after an eight-week treatment period (p < 0.0019), and its secondary endpoint, with a 100 percent improvement in quality of life domains versus placebo (p < 0.0007). I.V. CR845 was well-tolerated in the trial.
About the Ongoing Safety Trial of I.V. CR845 in Hemodialysis Patients
The 52-week Phase 3 safety study, which was initiated in the second quarter of 2017, is enrolling hemodialysis patients with CKD-associated pruritus (CKD-aP) who previously completed one of the Company's prior studies (CR845-CLIN2101 Part A or CR845-CLIN2005 Part B). This open-label trial is evaluating the long-term safety of I.V. CR845 at the 0.5 mcg/kg dose, which met both primary and secondary efficacy endpoints (reduction of itch and improved quality of life, respectively) in the completed Phase 2 trial in hemodialysis patients with moderate-to-severe CKD-aP, and is the selected dose for the planned Phase 3 pivotal trial.
CKD-aP is an intractable systemic itch condition that occurs with the greatest frequency and intensity in chronic kidney disease patients undergoing hemodialysis and peritoneal dialysis; however, pruritus has also been reported in CKD patients who are not yet on dialysis. Aggregate, longitudinal, multi-country studies estimate the weighted prevalence of CKD-aP to be approximately 40 percent in patients with end-stage renal disease (ESRD), with approximately 24 percent of patients reporting severe pruritus. The majority of dialysis patients (approximately 60-70 percent) report pruritus, with 30 to 40 percent reporting moderate or severe pruritus1,2.. 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 anti-pruritic treatments, such as anti-histamines and corticosteroids, which are 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.
1. Pisoni RL, Wikstrom B, Elder SJ, et al. Pruritus in haemodialysis patients: international results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant. 2006;21:3495-3505.
2. Ramakrishnan et al. Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms.
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 the timing of the initiation of the company's planned pivotal Phase 3 efficacy trial for the treatment of CKD-aP in hemodialysis 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. Such risks include the risk that the planned clinical trial may not be initiated as expected based on delays, for example in onboarding the clinical trial sites and screening and enrolling candidates. Additional factors that could cause actual results to differ from those expressed or implied by forward-looking statements are described in Cara's filings with the
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