Cara Therapeutics Itching Drug Scratches Off Goals of Phase 3 Test
Summary
A Cara Therapeutics drug developed to treat the severe itching experienced by patients receiving hemodialysis has met the main goal of a second late-stage study, setting up the experimental medicine for regulatory filings in the US and Europe. “We took quite some time with the FDA to define what a reduction threshold in [the itching score] means with respect to clinical meaningfulness, and that was an analysis we performed empirically on our Phase 2 data,” Chalmers said. “From that analysis, it’s clear that a three-point reduction is very much clinically meaningful for a hemodialysis patient suffering from pruritus.” As for the drug falling short of statistical significance in improving quality of life, Chalmers said that those measures will not be part of the drug’s label and Cara is not relying on them for regulatory approval. Menlo Therapeutics (NASDAQ: MNLO) tried to treat it with a small molecule, serlopitant, designed to block neurokinin 1 receptor, a nerve signaling path for itching. If the drug wins FDA approval, Cara has a profit-sharing agreement with VFMCRP that calls for the companies to work together to commericalize the treatment in Fresenius Medical Care’s 2,400 North America dialysis clinics.
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