Cara Therapeutics Wins Big on FDA Breakthrough

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Cara Therapeutics Inc. (NASDAQ: CARA) saw its shares make a handy gain on Friday after the company said that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy designation for its I.V. CR845 for the treatment of moderate-to-severe uremic pruritus (UP) in chronic kidney disease (CKD) patients undergoing hemodialysis.

For some quick background: UP is an intractable systemic itch condition that occurs with the greatest frequency and intensity in CKD patients under hemodialysis and peritoneal dialysis. However, pruritus has also been reported in CKD patients who are not yet on dialysis.

The Breakthrough Therapy designation is generally granted to expedite the development and review process for new therapies addressing serious or life-threatening conditions, where preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

This regulatory decision was driven by positive top-line results from Part A of a Phase 2/3 clinical trial in patients with UP. Part A of the trial met its primary endpoint, with a 68% reduction in worst itching scores versus placebo after an eight-week treatment period, and its secondary endpoint, with a 100% improvement in quality of life domains versus placebo. I.V. CR845 was well-tolerated in the trial.

Derek Chalmers, PhD, DSc, president and CEO of Cara, commented:

The FDA’s decision to grant Breakthrough Therapy designation is recognition of both the significant unmet medical need among CKD patients with UP and the potential of I.V. CR845 to address it. We have already initiated our Phase 3 program and look forward to working closely with the FDA to bring this potential new treatment option to hemodialysis patients as quickly as possible.

Shares of Cara were last seen up about 14% at $22.65 on Friday, with a consensus analyst price target of $26.88 and a 52-week range of $4.35 to $23.51.