Cara Therapeutics, Inc. announced that it will focus its resources on the oral difelikefalin Phase 2/3 clinical program in notalgia paresthetica (NP) and significantly reduce its operating expenses. These measures will extend the Company?s cash runway into 2026, enabling the expected completion of the NP clinical program. Enrollment in the Phase 2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with NP, known as KOURAGE, is progressing ahead of the Company?s projections.

A data readout from the dose-finding portion of the program is expected in the third quarter of 2024. Final topline results from the first pivotal study are expected by the end of 2025 with the second pivotal study results in early 2026. KOURAGE is a Phase 2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica (NP).

The program is comprised of two studies ? KOURAGE 1 and KOURAGE 2 ? which are double-blind, placebo-controlled, 8-week studies with patients allowed to roll-over into open-label 52-week extensions.

KOURAGE 1 is composed of two parts. The dose-finding portion of KOURAGE 1 (Part A) is expected to include 200 patients who will be randomized equally to four arms (0.25 mg BID, 1.0 mg BID, 2.0 mg BID, placebo BID). The Company expects a data readout from the dose-finding portion of KOURAGE 1 in the third quarter of 2024.

This readout will provide key information, specifically the dose and sample size to initiate the Phase 3 portions of the program ? Part B of KOURAGE 1 and the second pivotal study KOURAGE 2. Part B and KOURAGE 2 will be double-blind, placebo-controlled, 8-week studies with patients randomized 1:1 to either difelikefalin or matching placebo. The primary endpoint will be the proportion of patients with a =4-point improvement at Week 8 from baseline in the worst itch numeric rating scale.

The Company expects final topline results from the first pivotal study by the end of 2025 with the second study by early 2026.