CARA THERAPEUTICS, INC. Item 7.01. Regulation FD Disclosure.
On
The information furnished under this Item 7.01, including Exhibit 99.1 and
Exhibit 99.2, shall not be deemed "filed" for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or subject to the liabilities of
that section. The information shall not be deemed incorporated by reference into
any other filing with the
Item 8.01. Other Information.
On
The KARE Phase 2 trial was a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus in 401 adult subjects with AD. Patients were stratified across treatment groups by disease severity. KARE enrolled 64% of patients characterized as mild-to-moderate (BSA<10%) and 36% falling into the moderate-to-severe category (BSA>10%). Subjects were randomized to three tablet strengths of Oral KORSUVA: 0.25 mg, 0.5 mg and 1 mg taken twice daily (BID) versus placebo for 12 weeks followed by 4 weeks of an active extension phase. A prespecified interim conditional power assessment was conducted after approximately 50% of the originally targeted patient number completed the designated 12-week treatment period. Based on the Independent Data Monitoring Committee's recommendation, the sample size for the 0.5 mg dose and placebo groups was increased by approximately 60%, respectively.
Primary Efficacy Endpoint
· KARE's primary efficacy endpoint was change from baseline in the weekly mean of
the daily 24-hour Itch numerical rating scale ("NRS") score at week 12 of the
treatment period. Although no dose group met this endpoint, a statistically
significant improvement from baseline was evident as early as week 1 for the 1
mg dose group, which was sustained through 75% of the treatment period.
· In a prespecified analysis, a statistically significant change in the primary
efficacy endpoint was observed in the mild-to-moderate (BSA<10%) patient population (p=0.036, All doses versus placebo) which was evident at week 1 and sustained through the treatment period. Key Secondary Endpoint
· The key secondary endpoint for KARE was the assessment of the proportion of
patients achieving an improvement from baseline of ?4 points with respect to the weekly mean of the daily 24-hour Itch NRS score at week 12 (4-point Responder Analysis). No dose group met this endpoint for the ITT population.
· Prespecified analysis by disease severity indicated a statistically significant
improvement in the 4-point Responder Analysis in the mild-to-moderate (BSA<10%) patient population with 32% of KORSUVA-treated patients achieving a ?4 point reduction in NRS at Week 12 versus 19% in the placebo group (p=0.033, All doses versus placebo). A statistically significant improvement was also achieved for the 0.5 mg dose (p=0.046, 0.5 mg versus placebo). Safety and Tolerability
· Oral KORSUVA was generally well-tolerated across all doses. Overall, the
incidence of treatment-emergent adverse events ("AEs") was generally similar
across KORSUVA and placebo groups. The most common treatment-emergent AEs
reported in >5% of patients in any KORSUVA group and greater than placebo were
abdominal pain, nausea, dry mouth, headache, dizziness and hypertension (5/77
patients in 1 mg dose group; 4/5 of patients had documented prior history of
hypertension at enrollment).
2
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Press Release, datedApril 29, 2021 99.2 Presentation, datedApril 29, 2021 104 Cover page interactive data file (formatted as Inline XBRL) 3
© Edgar Online, source
