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Biotech / Medical : momo-T/FIF -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (11146)	6/29/2017 4:14:13 PM
From: tuck	Read Replies (1) \| Respond to of 12215

>>Cara Therapeutics Announces Top-line Results From Phase 2b Trial of Oral CR845 in Chronic Pain Patients With Osteoarthritis of the Hip or Knee 4:01 pm ET June 29, 2017 (Globe Newswire) Print - Statistically significant 39 percent reduction in mean joint pain score in hip patients at eight weeks with 5.0 mg dose - - 35 percent reduction in mean joint pain score for all patients at eight weeks with 5.0 mg dose - - All tablet strengths well tolerated over eight-week treatment period - - Conference call today at 4:30 p.m. ET - Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, today announced top-line results from a Phase 2b 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. "Developing effective analgesics that lack the high abuse potential and serious side effects of currently available drug classes remains the most pressing need in chronic pain," said Dr. Ajay D. Wasan, M.D., M.Sc., Professor of Anesthesiology and Psychiatry, Vice Chair for Pain Medicine, Department of Anesthesiology, University of Pittsburgh Medical Center (UPMC). "The magnitude of the reduction in mean joint pain scores observed in all patients in this trial together with an encouraging safety profile underscores the significant potential of CR845 as a new therapeutic approach for the treatment of chronic inflammatory pain." Oral CR845 Phase 2b Trial Design and Results The Phase 2b trial was a randomized, double-blind, placebo-controlled trial of three tablet strengths of CR845, 1.0 mg, 2.5 mg and 5.0 mg, dosed twice a day (BID) over an eight-week treatment period in 476 patients with osteoarthritis of the hip or knee experiencing moderate-to-severe pain. -- The primary efficacy endpoint was the change from baseline at week eight, with respect to the weekly mean of the daily pain intensity score using a numerical rating scale (NRS). -- Secondary endpoints included overall Patient Global Assessment (PGA) score, mean reduction in rescue medication and overall improvement in WOMAC scores. -- The trial design incorporated a four-week titration period for a response, followed by a four-week maintenance period. Sixty-seven percent of CR845-treated patients in the maintenance period titrated to the 5.0 mg dose after the four-week titration period, based on change in the observed mean joint pain score (NRS). -- Patients with OA of the hip maintained on the 5.0 mg dose to the end of the eight-week treatment period exhibited a statistically significant 39 percent reduction in mean joint pain score (p=0.043 vs. placebo); all patients (OA of the knee or hip) maintained on the 5.0 mg dose to the end of the eight-week treatment period exhibited a 35 percent reduction in mean joint pain score (p=0.111 vs. placebo). -- Patients maintained on the 1.0 mg and 2.5 mg tablet strengths did not exhibit significant reductions in mean joint pain scores compared to placebo. -- For patients maintained on the 5.0 mg dose, there was a statistically significant increase in the proportion of patients whose OA was "very much improved" or "much improved" as indicated by Patient Global Assessment score in both the total patient group (p <0.005 vs. placebo) and in patients with primary OA of the hip (p<0.006 vs. placebo). -- The reduction in pain score in the 5.0 mg dose group in hip patients was accompanied by a reduction in mean rescue medication of 41 percent at week eight versus placebo. -- An overall improvement of 62 percent from baseline in WOMAC scores was observed over the eight-week treatment period for the 5.0 mg dose group in hip patients. -- All tablet strengths were generally well tolerated with no drug-related serious adverse events (SAEs). For the 5.0 mg dose, the most common adverse events reported at the >5 percent incidence level were dry mouth (six percent) and constipation (12 percent). Importantly, there were no clinically significant changes in serum sodium levels observed during the eight-week treatment period for any dose group. "We believe that the present trial of oral CR845 has highlighted the potential of a peripherally acting kappa agonist to provide clinical benefit in a chronic pain population and we're pleased that statistical significance was achieved for the 5.0 mg dose in patients with OA of the hip," said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. "The drug was observed to be well tolerated over the treatment period and this overall data set will inform both our dose selection and patient population in designing our next trial of oral CR845 in OA patients." Conference Call Cara management will host a conference call today at 4:30 p.m. ET to discuss the Oral CR845 OA trial results and next steps for the program. To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 47802588. A live webcast of the call can be accessed under "Events and Presentations" in the News & Investors section of the Company's website at www.CaraTherapeutics.com. An archived webcast recording will be available on the Cara website beginning approximately two hours after the call.<< Well, this is interesting. Stat sig in the hip, but apparently not the knee. And I don't know what was expected in terms of reduction in rescue medication. Stock is having a moderate after hours firesafe prior to the CC. Cheers, Tuck