ANNOUNCES RESULTS OF CHRYSALIN STUDY
OrthoLogic has announced the results of its Phase III clinical trial of the novel synthetic peptide Chrysalin (TP508) in unstable, displaced distal radius (wrist) fractures. Treatment with 10 ug of Chrysalin did not demonstrate a statistically significant benefit compared to placebo in the primary efficacy endpoint of time to removal of immobilization.
A secondary endpoint, radiographic evidence of time to radial cortical bridging, showed a statistically significant benefit for Chrysalin-treated subjects. This benefit mirrored findings from the Phase I/II clinical trial that provided part of the foundation for the Phase III study. No difference was observed between Chrysalin treatment and placebo in the other secondary endpoints.
The trial met the pre-specified safety endpoint by demonstrating no significant difference in adverse event rates between the Chrysalin and placebo groups.