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Cara Therapeutics' 15% Surge, Explained

Cara Therapeutics' 15% Surge, Explained

Shares of Cara Therapeutics Inc (NASDAQ: CARA), a small-cap clinical-stage bio-pharmaceutical company that develops therapies to alleviate pain, gained more than 15 percent early Tuesday morning after the company announced encouraging results from Part A of a Phase 2/3 trial.

Cara has been exploring its therapy called CR845, a peripherally acting kappa opioid receptor agonist used for the treatment of acute and chronic pain and pruritus. The clinical trial consisted of patients undergoing laparoscopic hysterectomy or bunionectomy procedures.

Back in early 2016, Cara's stock plunged nearly 50 percent after the U.S. Food and Drug Administration placed the company's pain trial exploring CR845 on clinical hold. As such, Tuesday's announcement is a welcome development for investors and potential patients who could benefit from the company's therapy in the future.

The Results

Cara said that top-line results from Part A of its Phase 2/3 trial showed that CR845 met both the primary and secondary endpoints for efficacy (reduced itching and improved quality of life, respectively) among people with uremic pruritus, an intractable and debilitating systemic itch condition for which there are no approved therapies.

Cara also stated it plans on meeting with the FDA for an end-of-Phase 2 meeting to review the reported results and to also determine an optimal dose to take into Part B of this Phase 2/3 study as well as defining a path toward approval.

A conference call is scheduled for Tuesday morning at 8:30 a.m. ET to discuss the results as well as the next step for the program.

"This study demonstrated encouraging, statistically significant improvements across quality of life measures for hemodialysis patients with this condition," said Mark Unruh, M.D., chair of the department of internal medicine at the University of New Mexico School of Medicine. "Importantly, these improvements persisted for the entire eight-week treatment period, with the anti-itch effect apparently sustained over time, suggesting that CR845 has the potential to be an effective treatment for this difficult condition, if successfully developed and approved."

"We are extremely pleased with these results, where I.V. CR845 demonstrated sustained clinical and quality of life benefits in dialysis patients suffering from UP and supports the viability of this therapeutic approach for the long-term treatment of this unmet medical need," said Derek Chalmers, Ph.D., D.Sc., president and CEO of Cara Therapeutics. "As a next step, we plan to meet with the FDA to finalize the trial design of Part B of this Phase 2/3 study and to initiate patient recruitment later this year."

At last check, shares of Cara were up 14.55 percent at $20.79 in Tuesday's pre-market session.

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