Trial Will Evaluate Safety, Pharmacokinetics and Effectiveness of Four Tablet Strengths Dosed Over Two Weeks in Osteoarthritis Patients
SHELTON, CT, USA I August 17, 2015 I 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 the dosing of the first patients in a Phase 2 trial of an oral tablet formulation of its peripherally selective kappa opioid agonist, CR845, for the treatment of osteoarthritis (OA).
“The initiation of this osteoarthritis trial is an important step toward establishing the potential clinical utility of our oral CR845 formulation in the treatment of chronic inflammatory pain,” said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. “CR845’s novel peripheral mechanism of action may ultimately provide a safer, non-abusable alternative to NSAIDs and narcotic opioids, and satisfy a significant unmet need among osteoarthritis patients and potentially general chronic pain patients.”
The Phase 2 trial is a single-blind, randomized, multiple ascending dose trial designed to evaluate the safety, pharmacokinetics (PK) and effectiveness of oral CR845 tablets dosed over a two-week treatment period in OA patients experiencing moderate-to-severe pain, defined as >4 on a 10-point Visual Analog Scale (VAS). The trial will enroll 80 OA patients at multiple sites in the U.S. Four tablet strengths (0.25 mg, 0.5 mg, 1.0 mg and 5 mg) will be administered twice a day. In addition to safety and PK observations, pharmacodynamics endpoints will include change from baseline in joint pain using the Numeric Rating Scale (NRS), change from baseline in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Patient Global Assessment (PGA) of OA. Exploratory measurements of inflammatory biomarkers will be assessed at baseline and post-CR845 treatment.
About CR845
CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and pruritus. In multiple randomized, double-blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in both pain intensity and opioid-related side effects. In more than 440 subjects dosed to date, I.V. CR845 was found to be safe and well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists. Cara expects to initiate its Phase 3 Program of I.V. CR845 for acute pain with a first adaptive pivotal trial in laparoscopic abdominal surgery in 3Q’15.
About Cara Therapeutics
Cara Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.
SOURCE: Cara Therapeutics
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Trial Will Evaluate Safety, Pharmacokinetics and Effectiveness of Four Tablet Strengths Dosed Over Two Weeks in Osteoarthritis Patients
SHELTON, CT, USA I August 17, 2015 I 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 the dosing of the first patients in a Phase 2 trial of an oral tablet formulation of its peripherally selective kappa opioid agonist, CR845, for the treatment of osteoarthritis (OA).
“The initiation of this osteoarthritis trial is an important step toward establishing the potential clinical utility of our oral CR845 formulation in the treatment of chronic inflammatory pain,” said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. “CR845’s novel peripheral mechanism of action may ultimately provide a safer, non-abusable alternative to NSAIDs and narcotic opioids, and satisfy a significant unmet need among osteoarthritis patients and potentially general chronic pain patients.”
The Phase 2 trial is a single-blind, randomized, multiple ascending dose trial designed to evaluate the safety, pharmacokinetics (PK) and effectiveness of oral CR845 tablets dosed over a two-week treatment period in OA patients experiencing moderate-to-severe pain, defined as >4 on a 10-point Visual Analog Scale (VAS). The trial will enroll 80 OA patients at multiple sites in the U.S. Four tablet strengths (0.25 mg, 0.5 mg, 1.0 mg and 5 mg) will be administered twice a day. In addition to safety and PK observations, pharmacodynamics endpoints will include change from baseline in joint pain using the Numeric Rating Scale (NRS), change from baseline in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Patient Global Assessment (PGA) of OA. Exploratory measurements of inflammatory biomarkers will be assessed at baseline and post-CR845 treatment.
About CR845
CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and pruritus. In multiple randomized, double-blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in both pain intensity and opioid-related side effects. In more than 440 subjects dosed to date, I.V. CR845 was found to be safe and well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists. Cara expects to initiate its Phase 3 Program of I.V. CR845 for acute pain with a first adaptive pivotal trial in laparoscopic abdominal surgery in 3Q’15.
About Cara Therapeutics
Cara Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.
SOURCE: Cara Therapeutics
Post Views: 75
