– Met primary endpoint with statistically significant reduction in mean worst itching intensity NRS scores with 1 mg tablet strength vs. placebo after 12-week treatment period (p=0.018) –
– Oral KORSUVA™ well-tolerated after 12 weeks of treatment –
– Conference call today at 8:30 a.m. ET –
“CKD-associated pruritus remains a significant unmet need for approximately one-third of diagnosed CKD patients in the U.S.,” said
“These exciting results underscore Oral KORSUVA’s potential to be the first approved therapy in the U.S. for CKD patients suffering from moderate-to-severe pruritus,” said Gil Yosipovitch, M.D., Professor,
Phase 2 Trial
The Phase 2, multicenter, randomized, double-blind, placebo-controlled 12-week trial was designed to evaluate the safety and efficacy of three dose levels (0.25 mg, 0.5 mg and 1 mg, once daily) of Oral KORSUVA vs. placebo (randomized 1:1:1:1) in approximately 240 stage III-V CKD patients with moderate-to-severe pruritus.
The primary efficacy endpoint was the change from baseline in the weekly mean of the daily 24-hour Worst Itching Intensity Numeric Rating Scale (WI-NRS) score at Week 12 of the treatment period for any of the three tablet strengths vs. placebo. Secondary endpoints included change from baseline in itch-related quality of life scores at the end of Week 12, as assessed by the total Skindex-10 and 5-D itch scales, as well as the proportion of patients achieving an improvement from baseline of ≥3 points with respect to the weekly mean of the daily 24-hour Worst Itch NRS score at Week 12.
Primary Endpoint: Patients treated with the 1 mg tablet strength of Oral KORSUVA™ achieved the primary endpoint of statistically significant reduction in weekly mean of the daily WI-NRS scores vs. placebo after the 12-week treatment period (-4.4 KORSUVA vs. -3.3 placebo, p=0.018). The treatment effect was statistically significant after two weeks of treatment and sustained through the 12-week treatment period.
Secondary Endpoints: The proportion of patients on 1 mg tablet strength achieving a 3 point or greater improvement from baseline in the weekly mean of the daily WI-NRS score at week 12 was 72% vs. 58% for placebo but did not achieve statistical significance.
Patients on 1 mg tablet strength showed positive improvements vs. placebo in itch- related quality of life endpoints as measured using self-assessment Skindex-10 and 5-D Itch scales but did not achieve statistical significance.
Safety and Tolerability: Oral KORSUVA was generally well-tolerated with a safety profile consistent with that seen in earlier KORSUVA clinical trials. Overall, the incidence of treatment emergent adverse events (AEs) were similar across KORSUVA and placebo groups. The most common treatment emergent AEs reported in >5% of patients in the 1 mg KORSUVA group vs. placebo were dizziness (7.5% KORSUVA vs. 0% placebo), fall (6% KORSUVA vs. 0% placebo), diarrhea (6% KORSUVA vs. 1.5% placebo) and constipation (KORSUVA 6% vs. 3% placebo).
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 8695654. A live webcast of the call can be accessed under "Events & 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 CKD-Associated Pruritus (CKD-aP)
CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients with CKD undergoing hemodialysis and peritoneal dialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis. According to estimates from the
2. Sukul N, et al. Pruritus in Chronic Kidney Disease Patients: Early Results from CKDopps. ERA-EDTA Abstract.
3. IMS Pruritus Market Landscape Analysis. September 2014.
4. Mathur VS, et al. A longitudinal study of uremic pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010; 5(8):1410-1419.
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 ongoing trials and future development of the Company’s product candidates, including the planned Phase 3 registration trials of Oral KORSUVA, as well as the potential for Oral KORSUVA to be approved for treatment of CKD-associated pruritus. 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 Cara's filings with the Securities and Exchange Commission, including the "Risk Factors" section of Cara's Annual Report on Form 10-K for the year ended December 31, 2018 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. 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 undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Stern Investor Relations, Inc.
Source: Cara Therapeutics, Inc.