The scrutiny follows allegations of data manipulation and misleading claims about the drug’s effectiveness, leading the Securities and Exchange Commission to charge the company, which resulted in a $40 million settlement.
Despite the allegations, Cassava continues to advance its phase 3 trials, enrolling over 1,900 patients diagnosed with mild to moderate Alzheimer’s disease. The company maintains that remaining research and clinical results suggest the drug may still offer potential benefits.
However, Alzheimer’s researcher George Perry from the University of Texas at San Antonio told the news outlet he was baffled by the decision to continue the trials amid ongoing data integrity issues.
“If the efficacy and the underlying data is being questioned, which it is, why would you continue the study?” Perry said.
The FDA has the authority to pause or terminate clinical trials if it discovers issues related to data integrity. While the agency has not commented specifically about the simufilam situation, it routinely reviews trials and takes actions to protect participants.
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