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Unigene Platform Leads to Clinical Trial

Cara uses Peptelligence to advance CR845 formulation

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Cara Therapeutics, a client of Unigene Laboratories, has commenced a Phase I study of its oral proprietary peptide-based, investigational drug, CR845, a novel peripherally-acting kappa opioid agonist in healthy volunteers. The CR845 oral capsules were formulated using Unigene’s validated, proprietary peptide manufacturing technology under a Manufacturing and Clinical Supply Agreement established in May 2011.

Ashleigh Palmer, Unigene’s president and chief executive officer, commented, “The commencement of Cara’s Phase I study of CR845 is the first clinical study initiated as a result of launching our new strategy a year ago and further validates our mission to deploy Peptelligence into as many oral peptide development programs as possible. With seven feasibility studies ongoing or completed, we believe we are well positioned to build a diverse portfolio of highly targeted project proposals from which we plan to generate near-term revenue from feasibility studies and service fees, while establishing a solid foundation for the potential of licensing agreements with high-value milestones and royalties.”

“Initiation of this trial represents an important advancement in the clinical potential of CR845 and will provide the basis for developing the drug beyond the treatment of acute pain in a hospital setting,” said Frederique Menzaghi, vice president of R&D at Cara Therapeutics. “There remains a significant unmet need among chronic pain patients for an effective analgesic without the debilitating or dangerous side-effects of currently used narcotic analgesics and NSAIDs. We believe that an oral formulation of CR845 has the potential to provide an effective and safer option for the treatment of chronic pain.”

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