Annovis Bio had my biotech bull%^&! meter running red after it made a late change to the design of a Phase 3 study in Parkinson’s disease. But then I got an extraordinary explanation from CEO Maria Maccecchini. Now, I’m less worried about data spin because, by her own admission, the odds that the study succeeds, post endpoint change, are a lot lower.
Results from the completed Parkinson’s study, which is investigating Annovis’ drug called buntanetap, are well past due because of what the company has described as ongoing “data cleaning efforts.” The delay was announced on Jan. 24. Two weeks later, on Feb. 6, the primary efficacy endpoint of the study was changed, according to an update posted to the U.S. government’s clinical trials database.
Red flag, I thought, until I emailed Maccecchini, asking for an explanation. In response, she told me Annovis made the key endpoint change in August, based on a recommendation from officials at the Food and Drug Administration after the agency had reviewed data from an interim analysis of the study. It took the company another six months to update the study design in the ClinicalTrials.gov database, for reasons she did not explain.
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