Annovis Bio made a late change to the design of a Phase 3 study in Parkinson’s disease, raising concerns initially. However, CEO Maria Maccecchini provided an explanation that eased worries. The company’s drug, buntanetap, is being investigated in the study, with results delayed due to ongoing data cleaning efforts. The primary endpoint of the study was changed two weeks after the delay was announced, which initially raised red flags. However, the change had been recommended by FDA officials based on interim analysis data. The study design was updated in the ClinicalTrials.gov database six months later, without a clear explanation.
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