Macritonin oral calcitonin capsules: Phase III data; MAA under review in Europe

CCS reported analysis of one-year bone mineral density (BMD) data from its two-year 560-patient European trial that is being run to provide clinical data in support of the company's MAA for Macritonin. Patients in the trial receive either 200 IU calcitonin intranasally as a positive control or placebo, 100, 200, 400 or 800 IU Macritonin orally, and all receive calcium and vitamin D supplements. CCS, which remains blinded to the trial data, said the analysis was to determine the number of patients necessary for a U.S. trial of the compound.

After one year, a dose-dependent improvement in BMD, a surrogate marker for risk of bone fractures, was seen with Macritonin therapy. However, the 100 and 200 IU doses had only a small effect beyond the placebo group, and those doses will be dropped from the European trial. The other dose arms in the trial will continue. ...