Despite having an FDA-approved injectable product, pruritus-focused drug developer Cara Therapeutics is laying off up to half of its staff as it narrows its clinical ambitions.
The company said Monday that an oral version of Korsuva will be aimed primarily at treating moderate-to-severe pruritus in patients with a neuropathic disorder called notalgia paresthetica. Cara was previously testing the oral itch medication in individuals with advanced chronic kidney disease. The decision means up to 50% of Cara’s employees will be let go, with CSO and head of R&D Frédérique Menzaghi, Ph.D., also headed for the exits, effective February 2.
Cara has zeroed in on treating patients with pruritus—the medical term for an itching sensation—with the injectable version of Korsuva handed FDA approval in patients with chronic kidney disease. But sales have been sluggish, with Cara reporting $1.9 million in collaborative revenue off $4.4 million in sales in the third quarter. The company handed over U.S. commercialization rights to Vifor Pharma under a profit-sharing agreement.
By the end of September, Cara was left with $83.3 million, barely half of the $156.7 million it had entered 2023 with, a drop-off the biotech attributed primarily to operating expenses. Cara added $40 million after selling off royalty rights to HealthCare Royalty in November and ended the year with $101 million to hand.
Efforts to expand the use of Korsuva or its oral sibling have been unsuccessful to date, most recently at the end of 2023 when Cara said the oral option did not improve pruritus when used as an adjunct to steroids in patients with atopic dermatitis. The company previously failed a phase 2 atopic dermatitis trial after the oral asset showed no improvement in itch symptoms versus placebo across three different doses.
The good news, according to Cara, is that the phase 2/3 trial in patients with notalgia paresthetica is “ahead of the company’s projections.” A readout from the dose-finding portion of the study is expected in the third quarter of 2024 with a topline readout of the first pivotal study slated for the end of 2025.
Today’s restructuring and associated layoffs will extend its cash runway into 2026, which CEO Christopher Posner said would be enough to “reach all expected key value-inflection milestones in the [notalgia paresthetica] clinical program.”