Met primary endpoint with 68% reduction in worst itching scores versus placebo after eight-week treatment period (p < 0.0019)
Met secondary endpoint in quality of life domains versus placebo after eight-week treatment period (p < 0.0007)
I.V. CR845 well tolerated after eight weeks of treatment
Conference call today at
"We are extremely pleased with these results, where I.V. CR845 demonstrated sustained clinical and quality of life benefits in dialysis patients suffering from UP and supports the viability of this therapeutic approach for the long-term treatment of this unmet medical need," said
"These exciting results underscore I.V. CR845's potential, if successfully developed, to become an approved therapy in the
"This study demonstrated encouraging, statistically significant improvements across quality of life measures for hemodialysis patients
with this condition," said
I.V. CR845 Phase 2/3 UP Trial Design and Top-line Results
Part A of the Phase 2/3 UP trial was a randomized, double-blind, placebo-controlled trial of three doses of I.V. CR845 (0.5 ug/kg, 1.0 ug/kg, and 1.5 ug/kg) administered three times per week after dialysis over an eight-week treatment period in 174 patients with moderate-to-severe UP.
The primary endpoint was the change from baseline of the mean worst itching score for week eight (days 51-57) based on a validated 0-10 Numeric Rating Scale (NRS). Patients receiving I.V. CR845 experienced a 68 percent greater reduction from baseline in worst itch scores than those receiving placebo (p-value < 0.0019).
The secondary endpoint focused on quality of life measures associated with pruritus using the
Overall, I.V. CR845 was well tolerated over the eight-week treatment period and the unblinded Drug Safety Monitoring Board did not report any significant drug-related events during the course of the trial. The most common adverse events were transient paresthesia (primarily mid-facial tingling or numbness) and dizziness, as reported in previous clinical studies of I.V. CR845.
Cara plans to meet with the
Cara management will host a conference call today at
To participate in the conference call, please dial 855-445-2816 (domestic) or 484-756-4300 (international) and refer to conference ID 97080265. A live webcast of the call can be accessed under "Events and Presentations" in the News & Investors section of the Company's website at www.caratherapeutics.com.
An archived webcast recording will be available on the Cara website beginning approximately two hours after the call.
About Uremic Pruritus
Uremic pruritus (UP) is an intractable systemic itch condition that occurs with the greatest frequency and intensity in chronic kidney disease (CKD) patients under hemodialysis (HD) 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 UP to be approximately 40 percent of patients with end-stage renal disease (ESRD), with approximately 24 percent of patients reporting severe pruritus. Similarly, the majority of dialysis patients (approximately 60-70 percent) report pruritus, with 30 to 40 percent reporting moderate or severe pruritus. Recent data from the ITCH National Registry Study showed that among those with pruritus, 59 percent had 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. UP is also an independent predictor of mortality among HD patients, mainly related to increased risk of inflammation and infections.
CR845 is a peripherally-acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and pruritus. In multiple randomized, double-blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in pain intensity and opioid-related side effects. In more than 600 subjects dosed to date, I.V. CR845 was found to be well-tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally-acting (CNS-active) kappa opioid receptor agonists, and lacking the respiratory depression and abuse liability of mu opioid receptor agonists. Top-line data from a Phase 2b trial of CR845 in chronic pain associated with osteoarthritis and a conditional power analysis from an adaptive Phase 3 trial in postoperative pain are expected in the second quarter of 2017.
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 expected timing of the initiation of Part B of the trial for I.V. CR845 for UP, timing of a meeting with the
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