'We are delighted with this outcome and congratulate the Cara team on the positive topline phase-III data on KORSUVA Injection in haemodialysis patients with moderate-to-severe pruritus,' said
'We are very pleased with the positive topline data from our global, pivotal phase-III trial of KORSUVA Injection, which reinforce the robust results we reported from our
CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients undergoing hemodialysis. Multiple studies estimate that at least 40 percent of dialysis patients suffer from pruritus. The FDA has granted Breakthrough Therapy designation to KORSUVA Injection for this indication.
KALM-2 Efficacy Data
Primary Endpoint: The proportion of patients on 0.5 mcg/kg of KORSUVA Injection achieving a three-point or greater improvement from baseline in the weekly mean of the daily 24 hour Worst Itching Intensity Numeric Rating Scale (WI-NRS) score at week 12 was 54% vs.42% for patients on placebo (p= 0.02)
Key Secondary Endpoint: The proportion of patients on 0.5 mcg/kg of KORSUVA Injection achieving a four-point or greater improvement from baseline in the weekly mean of the daily 24 hour WI-NRS score at week 12 was 41% vs. 28% for patients on placebo (p= 0.01)
Itch-related Quality of Life Measures: Patients on KORSUVA Injection experienced a 12% and 29% numerical improvement in the average total
KALM-2 Safety and Tolerability
KORSUVA was generally well-tolerated with a safety profile consistent with that seen in KALM-1 and in the KORSUVA clinical program in patients with CKD-aP. Overall, the incidence of adverse events (AEs) and serious AEs were similar across both KORSUVA and placebo groups. The most common treatment emergent AEs reported in >5% of patients were diarrhea (8.1% KORSUVA vs 5.5% placebo), fall (6.8% KORSUVA vs 5.1% placebo), vomiting (6.4% KORSUVA vs 5.9% placebo), nausea (6.4% KORSUVA vs 4.2% placebo) and dizziness (5.5% KORSUVA vs 5.1 % placebo).
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KALM-2 phase-III Trial Design
KALM-2 is a phase-III, global, multicenter, randomized, double-blind, placebo-controlled, 12-week trial (with a 52-week open label extension phase) designed to evaluate the safety and efficacy of 0.5 mcg/kg KORSUVA (CR845/difelikefalin) Injection in 473 hemodialysis patients with moderate-to-severe pruritus.
The primary efficacy endpoint is the proportion of patients achieving at least a 3-point improvement from baseline in the weekly mean of the daily 24-hour WI-NRS score at week 12.
Secondary endpoints include assessment of the proportion of patients achieving >4-point improvement from baseline in weekly mean of the daily 24-hour WI-NRS score at week 12, as well as itch-related quality of life changes measured using the validated self-assessment 5-D itch and
About CKD-aP
CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing dialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis. Aggregate, longitudinal, multi-country studies estimate the weighted prevalence of CKD-aP to be approximately 40 percent in patients on dialysis, with approximately 25 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 pruritus.1,2 Recent data from the ITCH National Registry Study showed that among those with pruritus, approximately 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.3 CKD-aP is also an independent predictor of mortality among hemodialysis patients, mainly related to increased risk of inflammation and infections.
About
About
The FDA has conditionally accepted KORSUVA as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.
Forward-looking Statements
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 plans, strategies and expectations for the future, including the potential results of ongoing and planned clinical trials, future regulatory submissions; the size of the potential markets that are potentially addressable for the Company's product candidates, including the pruritus market and the potential for KORSUVA Injection to be a therapeutic option for CKD-aP. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Cara and VFMCRP undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contact:
Nathalie Ponnier
Tel: +41 79 957 96 73
Email: media@viforpharma.com
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