Unigene Laboratories claims a Phase III trial has validated its oral peptide drug delivery technology.
Tarsa Therapeutics has licensed the delivery technology to produce an oral formulation of calcitonin, an approved treatment for postmenopausal osteoporosis. In a Phase III trial the primary endpoint was achieved, supporting new drug application (NDA) submission plans.
“The successful outcome of this study not only validates our propriety oral peptide delivery technology and state-of-the-art recombinant manufacturing capabilities, but highlights our overall competence in the peptide sector”, said Ashleigh Palmer, CEO and president of Unigene.
An oral formulation of calcitonin would be more convenient than existing intranasal and injectable products.