Unigene Laboratories signed a clinical manufacturing services agreement with Cara Therapeutics. Unigene will use its peptide manufacturing technology to provide clinical supply material for Cara’s Phase I study of CR845.
The trial is expected to begin in the second half of this year. The firm will be testing CR845, a peripherally acting kappa opioid agonist, as a treatment for acute and chronic pain. It is also in Phase II development as an IV formulation for the treatment of post-operative pain.
Since CR845 works to activate peripheral opioid receptors located on sensory nerves and immune cells but not the brain, Cara reports that the drug overcomes side effects associated with other analgesics, like sedation, respiratory depression, and abuse liability.
Unigene was selected for production after its technology, Peptelligence, proved its capabilities in a feasibility study conducted by the companies. Core assets of this platform include oral and nasal peptide delivery technologies as well as high-yield, scalable, and reproducible E. coli-based manufacturing technologies.
Unigene’s first product to market, Fortical®, a nasal calcitonin medication, is among drugs that have leveraged Peptelligence. It received FDA approval in 2005 and is marketed in the U.S. by Upsher-Smith for the treatment of postmenopausal osteoporosis. Unigene has licensed its oral calcitonin program to Tarsa Therapeutics and expects an NDA filing before year end.
The company also has a worldwide licensing agreement with GlaxoSmithKline for its parathyroid hormone candidate currently in Phase II. In addition, Unigene has a manufacturing license agreement with Novartis, which is completing three Phase III studies of oral calcitonin for the treatment of osteoporosis and osteoarthritis.