Cara Therapeutics Focuses on Notalgia Paresthetica Trial, Secures Funds to 2026

Cara Therapeutics, a biopharmaceutical firm, has decided to concentrate its efforts on advancing its oral difelikefalin Phase 2/3 clinical program for notalgia paresthetica (NP), a neuropathic disorder that lacks sufficient treatment options. This strategic move is accompanied by a significant reduction in operational expenses, including a workforce cut of up to 50%. The company aims to extend its cash reserves, which stood at approximately $101 million at the end of 2023, to last until 2026, thus supporting the completion of the NP clinical program.

Christopher Posner, the company's President and CEO, emphasized the potential of oral difelikefalin for NP, which is believed to hold significant commercial prospects. The decision to halt the Phase 3 program for advanced chronic kidney disease (CKD) was not taken lightly, and Posner expressed gratitude to all those involved in the CKD program. The company is now pivoting to focus on the KOURAGE program, which is evaluating oral difelikefalin for treating moderate-to-severe pruritus in NP patients. The enrollment for this program is ahead of schedule, and data from the dose-finding phase is anticipated in the third quarter of 2024, with final results expected by the end of 2025 and early 2026.

NP, which affects the upper back and causes chronic itching, is a prevalent yet underdiagnosed condition with no FDA-approved treatments currently available. The KOURAGE program, consisting of two studies, KOURAGE 1 and KOURAGE 2, is a double-blind, placebo-controlled trial with an 8-week duration, allowing patients to continue into a 52-week open-label extension. The primary goal is to assess the proportion of patients experiencing a significant improvement in itching.

In addition to the clinical focus, there is a leadership change as Frédérique Menzaghi, Ph.D., the Chief Scientific Officer and SVP of Research & Development, will be leaving the company in early February 2024. Posner acknowledged her contributions and the impact of her scientific leadership over the past two decades.

Cara Therapeutics is a company committed to improving the lives of patients suffering from pruritus. Its KORSUVA® injection is the first FDA-approved treatment for moderate-to-severe pruritus associated with CKD in adults undergoing hemodialysis. The company's ongoing development of an oral formulation of difelikefalin for NP underscores its dedication to addressing unmet medical needs.