Actionable news
0
All posts from Actionable news
Actionable news in CARA: CARA THERAPEUTICS Inc,

Cara Therapeutics Announces Positive Top-Line Results From Phase 2a Trial of Oral CR845 in Chronic Pain Patients With Osteoarthritis of the Knee or Hip

  • Dose-related reduction observed in mean baseline pain score up to 34 percent after two weeks, with statistically significant reduction in mean rescue medication for top 5.0 mg dose
  • All four tablet strengths observed to be safe and well tolerated
  • Establishes therapeutic doses and dosing regimen for Phase 2b trial in 2016
  • Conference call today at 8:30 a.m. ET

SHELTON, Conn., Dec. 9, 2015 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced positive top-line results from a Phase 2a trial of an oral tablet formulation of the Company's peripherally selective kappa opioid agonist, CR845, in patients with osteoarthritis (OA) of the knee or hip. The results show:

  • The mean joint pain score (NRS score) exhibited a dose-related reduction from baseline to the end of the two-week treatment period, ranging from -25 percent at the lowest (0.25 mg) tablet strength up to -34 percent for the highest (5.0 mg) tablet strength.
  • 50 percent of the patients in the 5.0 mg dose group reported at least a 30 percent reduction in their pain score at the end of the treatment period.
  • Integrated AUC analysis of the overall NRS score for the entire treatment period indicated a statistically significant reduction in the 5.0 mg dose group compared to the three lower doses used in the trial (Wilcoxon Rank Sum Test: p=0.02).
  • The reduction in pain score in the 5.0 mg dose group was accompanied by a statistically significant reduction in mean rescue medication of approximately 80 percent (ANOVA: p= 0.02, for 5.0 mg vs lower dose groups).
  • 59 percent of patients in the 5.0 mg dose group used no rescue medication in Week 2 of the trial.
  • The effectiveness of the 5.0 mg dose was further supported by statistically significant, dose-related increases in the proportion of patients whose OA was "very much improved" or "much improved" as indicated by patient global assessment (Cochran-Mantel-Haenszel test, p=0.02, 2-sided).

An overall improvement in WOMAC scores was observed over time for all four tablet strengths, with the 5.0 mg dose group exhibiting a mean -38 percent improvement in WOMAC Index from baseline.

All tablet strengths were generally well tolerated with no drug-related SAEs. Dizziness (7 percent) and headache (6 percent) were the most common adverse events reported at the >5 percent incidence level.

"These results are an important first step in establishing the applicability of an oral...


More