Caladrius Biosciences’ Trial of CLBS03 for Type 1 Diabetes Fails to Show Improvement

Caladrius Biosciences (CLBS) said on Wednesday top-line results from its Phase 2a clinical trial of 110 subjects to evaluate the safety and efficacy of its CLBS03 for type 1 diabetes in adolescents failed to show improvement in the primary endpoint of preservation of C-peptide levels vs. placebo at 1 year.

Still, initial analysis of the 1-year follow-up data showed that CLBS03 was well tolerated at the doses tested in the study, the drugmaker said, adding that the database from this study is very large and the analysis and interpretation of all the information will require several months of intensive evaluation and will be critical to the decision regarding the next steps in development of CLBS03.

“The data from the 2-year follow-up, once complete, will afford supplemental information and are necessary to complete the evaluation of this therapy,” it said.

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