Cara Therapeutics Prioritizes Late-Stage Notalgia Paresthetica Program and Extends Cash Runway into 2026

– Focus on Phase 2/3 program in notalgia paresthetica (NP), a neuropathic disorder with significant unmet need –

– Phase 3 program in advanced chronic kidney disease (CKD) to be discontinued –

– Planned workforce reduction of up to 50% –

– Cara ended 2023 with approximately $101 million in cash; runway extended into 2026 –

– Company to host conference call and webcast today at 8:30 a.m. EST –

STAMFORD, Conn., Jan. 22, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA) today announced 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.

“We are sharpening our clinical focus on the rapidly progressing Phase 2/3 study in NP, which we believe is the therapeutic indication with the greatest commercial potential for oral difelikefalin,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “Following careful consideration, we have decided to discontinue our work in advanced chronic kidney disease (CKD). I would like to thank the patients and investigators who have participated in our advanced CKD clinical program, as well as our employees for their commitment to transforming the lives of CKD patients suffering from pruritus.”

Mr. Posner continued, “Unfortunately, as a result of the difficult decision to restructure the Company, many of our talented team members will depart the organization. I am deeply grateful for their dedicated service and support of our mission. We expect the changes we are making to extend our cash runway into 2026, allowing us to reach all expected key value-inflection milestones in the NP clinical program.”

Focus on Late-Stage Notalgia Paresthetica 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.