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news.Enteris BioPharma, an industry leader in innovative oral dosage formulations, has announced that its development partner, Cara Therapeutics (CARA) has dosed the first subjects in a further Phase 1a/1b clinical trial of a tablet formulation of its peripherally-selective kappa opioid agonist, CR845, for the treatment of acute and chronic pain.
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The tablet formulation of oral CR845 was formulated utilizing Enteris’ proprietary oral delivery technology under a Manufacturing and Clinical Supply Agreement. The agreement with Cara Therapeutics is representative of Enteris’ broader "Feasibility-to-Licensing" strategy involving its peptide and small molecule oral drug delivery platform.
Brian Zietsman, President and CFO of Enteris BioPharma, commented, "We are very pleased with the continued progress of oral CR845 as it showcases the potential of Enteris’ proprietary oral delivery technology and the value that we offer to strategic partners. The advancement of oral CR845 adds to the clinical validation of our oral drug delivery platform, which has been shown to be safe and well tolerated and has demonstrated clinically meaningful efficacy and enhanced bioavailability in Phase 2 and Phase 3 studies conducted by other partners."
As reported in the prior Phase 1 study, oral CR845 demonstrated a mean oral bioavailability of 16% across all groups under fasting conditions, with peak and total exposures proportional to each dose.
Peripheral kappa opioid receptor activation was seen at all doses tested as measured by a standard biomarker. Additionally, orally administered CR845 appeared to be safe and generally well tolerated across all doses tested.
Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics, remarked, "We continue to be very impressed with the bioavailability and bioactivity exhibited by the oral formulation of CR845, and we look forward to reporting top-line pharmacokinetic, safety and biomarker data from our Phase 1a/1b study in the fourth quarter of 2014. In our estimation, oral CR845 has the potential to address a significant market opportunity in the treatment of acute and chronic pain for which there continues to be a very large unmet need for safer, non-abusable alternatives to narcotic opioids and NSAIDs."