[ACCESSWIRE]
Upcoming AWS Coverage on Vertex Pharmaceuticals
LONDON, UK / ACCESSWIRE / March 29, 2017 / Active Wall St. blog coverage looks at the headline from Cara Therapeutics, Inc. (NASDAQ: CARA) as the Company announced on March 28, 2017, positive top-line results from Part A of its Phase-2/3 trial. The trial demonstrated that I.V. CR845 met both primary and secondary endpoints for efficacy (reducing itchiness and improving quality of life, respectively) in patients with uremic pruritus (UP). Register with us now for your free membership and blog access at:
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One of Cara Therapeutics' competitors within the Biotechnology space, Vertex Pharmaceuticals Inc. (NASDAQ: VRTX), is estimated to report earnings on April 26, 2017. AWS will be initiating a research report on Vertex Pharma following the release of its next earnings results.
Today, AWS is promoting its blog coverage on CARA; touching on VRTX. Get all of our free blog coverage and more by clicking on the link below:
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UP is a debilitating systemic itch condition with a high prevalence in patients with chronic kidney disease (CKD), for which there are no approved therapies in the United States.
"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 Chief Executive Officer 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."
I.V. CR845 Phase 2/3 UP Trial Design and Top-line Results
Part A of the Phase-2/3 UP trial was a randomized, double-blind, placebo-controlled trial of three doses of I.V. CR845 administered three times per week after dialysis over an eight-week treatment period in 174 patients with moderate-to-severe UP.
The primary endpoint was the change from baseline of the mean worst itching score for week eight based on a validated 0-10 Numeric Rating Scale. Patients receiving I.V. CR845 experienced a 68 percent greater reduction from baseline in worst itch scores than those receiving placebo.
The secondary endpoint focused on quality of life measures associated with pruritus using the Skindex-10 score, a validated self-assessment scale with higher scores indicating worse quality of life. Patients receiving I.V. CR845 experienced a 100% greater reduction from baseline in the average total Skindex-10 score at week eight than those receiving placebo. The total average Skindex-10 score reflected statistically significant reductions in each of the three Skindex-10 domains.
Cara Therapeutics plans to meet with the US Food and Drug Administration (FDA) for an end-of-Phase-2 meeting to review the results to determine an optimal dose to take into Part B of this Phase-2/3 study, and define the broader path towards approval. Pending discussions with the FDA, Part B of the study is intended to be a randomized, double-blind, placebo-controlled trial of I.V. CR845 administered three times per week after dialysis over a 12-week treatment period in up to 240 patients with moderate-to-severe UP.
Stock Performance
On Tuesday, March 28, 2017, following the announcement, the stock closed the trading session at $19.09, jumping 5.18% from its previous closing price of $18.15. A total volume of 7.63 million shares have exchanged hands, which was higher than the 3-month average volume of 1.81 million shares. Cara Therapeutics' stock price soared 17.77% in the last month, 91.47% in the past three months, and 146.32% in the previous six months. Furthermore, on a year to date basis, the stock surged 105.49%. At Tuesday's closing price, the stock's net capitalization stands at $519.06 million.
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