Cara Therapeutics has announced plans to dismiss up to 50% of its workforce in a bid to allocate cash resources towards a Phase II/III program for the itching condition notalgia paresthetica (NP).
The impending reshuffling, which will also see the departure of the current chief scientific officer Frédérique Menzaghi is expected to extend the company’s cash runway into 2026, based on a 22 January press release. This will see the NP clinical program to completion.
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Also on the chopping block is the Phase III KICK program. The program, comprised of a Phase III study (NCT05342623) initiated in May 2022 and another Phase III study (NCT05356403) initiated in August 2022, evaluates oral difelikefalin for moderate to severe pruritus associated with advanced chronic kidney disease (CKD). The company previously announced that enrolment was on track for the KICK studies and that topline results were anticipated in H2 2024, per a November 2023 financial update.
The Stamford, Connecticut-based biotech already has a US Food and Drug Administration (FDA) approval in the CKD indication with the Korsuva (difelikefalin) injection, a joint development with Vifor Pharma designed to treat moderate to severe pruritus in CKD patients undergoing hemodialysis (HD). GlobalData expects that Korsuva will generate $465m in 2029.
Phase II/III KOURAGE program (NCT05978063) for notalgia paresthetica is evaluating oral Korsuva, a kappa opioid receptor agonist, in a two pivotal studies, KOURAGE 1 and KOURAGE 2.
KOURAGE 1 is a two-part study with Part A encompassing the dose-finding portion evaluating 0.25 mg, 1.0 mg, 2.0 mg doses of oral Korsuva compared to placebo.
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By GlobalDataBoth Part B of KOURAGE 1 and KOURAGE 2 will further evaluate the benefit-risk profile of optimal dose in a double-blind, randomized, multi-centre study conducted over an 8-week period. The primary endpoint of the study will be proportion of patients achieving a ≥4-point improvement at Week 8 from baseline in the weekly mean of the 24-hour I-NRS score.
Cara expects to share data from KOURAGE 1 Part A in Q3 2024, while the overall topline results for KOURAGE 1 are expected by Q4 2025. Additionally, the data from the KOURAGE 2 trial is expected in early 2026.
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