FDA Calls Cara Therapeutics' Kidney Disease Drug a Breakthrough, Stock Soars

Published: Jun 26, 2017

FDA Calls Cara Therapeutics’ Kidney Disease Drug a Breakthrough, Stock Soars June 23, 2017
By Alex Keown, BioSpace.com Breaking News Staff

TAMFORD, Conn. – Shares of pain-relief company Cara Therapeutics are up more than 16 percent this morning after the company grabbed the Breakthrough Therapy Designation for its chronic kidney disease treatment CR845.

Cara’s treatment is designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors. The Federal Drug Administration granted the designation for patients with moderate-to-severe uremic pruritus (UP) in chronic kidney disease (CKD) patients undergoing hemodialysis.

Derek Chalmers, president and chief executive officer of Cara, said the FDA’s designation is a recognition of the potential of CR845 to address the need of CKD patients with UP. Uremic pruritus is an intractable systemic itch condition that occurs with the greatest frequency and intensity in chronic kidney disease patients under hemodialysis and peritoneal dialysis.

The company said the Breakthrough Therapy Designation was primarily supported by positive top-line results from Part A of a Phase II/III trial. Data from that trial showed that patients had a 68 percent reduction in worst itching scores versus placebo after an eight-week treatment period, which met primary endpoints. Secondary endpoints were also met with patients showing a 100 percent improvement in quality of life domains versus placebo.

“We have already initiated our Phase III program and look forward to working closely with the FDA to bring this potential new treatment option to hemodialysis patients as quickly as possible,” Chalmers said in a statement.

The current Phase III trial is a 52-week study that is enrolling up to 240 hemodialysis patients with CKD-associated pruritus who previously completed one of the company’s Phase II/III studies.

Breakthrough Therapy designation is 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 endpoint.

Cara Therapeutics is riding high this week. The FDA’s designation isn’t the only good news the company has seen in the past few days. On June 21, the company saw another spike in share prices after it release positive interim data for a Phase III trial of CR845 as a treatment for post-operative pain. Joseph Stauffer, chief medical officer of Cara, said in a statement that CR845 treatment has resulted in statistically significant reductions in pain intensity and opioid-related side effects. The Phase III trial is continuing to enroll patients undergoing abdominal surgery.

The company is also expecting top-line data from a Phase IIb trial of Oral CR845 in chronic pain associated with osteoarthritis are expected in the second quarter of 2017.

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