Notalgia Paresthetica Program Takes Priority as Cara Therapeutics Secures 2026 Cash Runway

Cara Therapeutics, a biopharmaceutical firm, has announced a strategic redirection to concentrate on its Phase 2/3 clinical trial for notalgia paresthetica (NP), a condition characterized by chronic itching of the upper back. The company has chosen to halt its Phase 3 program for advanced chronic kidney disease (CKD) and is implementing a workforce reduction of up to 50% to extend its financial runway to 2026.

The decision to focus on NP is driven by the therapeutic potential of the oral difelikefalin for this disorder, which currently has no FDA-approved treatments. The ongoing KOURAGE trial is evaluating difelikefalin's effectiveness in treating moderate-to-severe pruritus in NP patients. The company anticipates a data readout from the trial's dose-finding phase in the third quarter of 2024, with pivotal study results expected by the end of 2025 and early 2026.

Cara Therapeutics has approximately $101 million in cash reserves as of the end of 2023, which is now expected to sustain the company through the completion of the NP clinical program. The company's leadership has also been affected by the restructuring, with the departure of Frédérique Menzaghi, Ph.D., Chief Scientific Officer and SVP of Research & Development, scheduled for early February 2024.

The company's commitment to transforming the lives of patients with pruritus-related conditions remains, with its KORSUVA® injection being the first FDA-approved treatment for moderate-to-severe pruritus associated with CKD in hemodialysis patients. Cara Therapeutics continues to develop an oral formulation of difelikefalin, aiming to address the significant unmet need in the treatment of NP, which affects an estimated 650,000 patients in the U.S. under healthcare provider care, with potentially many more undiagnosed.

The company's focus on the NP clinical program underscores its dedication to advancing treatments for pruritus, a condition that significantly impacts the quality of life for many patients. Despite the challenges posed by the workforce reduction, Cara Therapeutics is poised to leverage its resources to bring forward a potential new treatment option for NP patients.