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news.Arizona biotech OrthoLogic has lost almost half its stock value after disappointing preliminary analysis of phase III trial results for its novel synthetic peptide Chrysalin in unstable wrist fractures.
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Data showed that treatment with Chrysalin (TP508) in the 503 participants did not relate to a statistically significant benefit compared to placebo in the primary efficacy endpoint, a measurement of time taken to heal and gain mobilization.
A secondary endpoint, radiographic evidence of time to radial cortical bridging, did show 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. However, no difference was observed between Chrysalin treatment and placebo in the other secondary endpoints.
OrthoLogic’s president and CEO Dr James Pusey said: “We will be conducting a full examination of these results in order to guide our program going forward, including a planned interim analysis of results from the ongoing phase IIb dose ranging trial of Chrysalin in distal radius fractures, which includes a 30ug dose.”
Results of the end-stage study evaluating Chrysalin in adult subjects with unstable or displaced distal radius fractures sent stock plummeting by 49% to $2.64 per share.