Cara Therapeutics Prioritizes Late-Stage Notalgia Paresthetica Program and Extends Cash Runway into 2026 - Seite 2

NP is a common but under-recognized neuropathic disorder characterized by chronic pruritus affecting the upper back. NP is challenging to manage, as there are currently no FDA-approved therapies to treat the disorder. Oral difelikefalin is the only therapy in development for NP. NP represents a sizable, underserved patient population with an estimated addressable market of 650,000 patients in the U.S. who are under the care of a healthcare provider, not accounting for those who are undiagnosed.

Leadership Update

Frédérique Menzaghi, Ph.D., Chief Scientific Officer and SVP of Research & Development, will depart the Company, effective February 2, 2024.

“On behalf of the entire Cara team, I would like to express our sincere gratitude to Fred for all her contributions and dedication to the organization over the past 20 years. As one of Cara’s founders, her scientific leadership helped shape the trajectory of the company from start-up to a publicly traded company,” said Mr. Posner.

Conference Call & Webcast

Cara will host a conference call and webcast today at 8:30 a.m. EST to discuss the corporate update.

To participate in the conference call, please register here. Registrants will receive the dial-in numbers and a unique PIN.

A live audio webcast and archived replay of the call will be available under “Events & Presentations” in the Investors section of the Company’s website at www.CaraTherapeutics.com.

About the KOURAGE Phase 2/3 Clinical Program in Notalgia Paresthetica

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.