The resulting average blood levels exceeded those that have been shown in third party studies using injectable parathyroid hormone (PTH) to stimulate bone growth in osteoporotic women. No serious or unexpected adverse events were reported, the company said.
The same improved solid dosage form used in this PTH study was successfully tested by Unigene in clinical studies with oral calcitonin conducted in 2008, and in those trials it also demonstrated superior performance when compared with earlier calcitonin studies that utilized Unigene’s original oral delivery technology.
Ronald Levy, executive vice president of Unigene, said: “Currently PTH is the only FDA-approved bone anabolic therapy and it is sold as an injectable product. These results are a major step forward in the development of an oral PTH product and we believe that this valuable know-how will make it easier for us to adapt our technology to orally deliver other peptides as well.”