FDA inspection report casts doubt on promising Alzheimer's drug trial results
In a recent FDA inspection report, concerning revelations have surfaced about the potential Alzheimer's drug, simufilam, developed by Cassava Sciences. The investigation was centered around pharmacologist Hoau-Yan Wang's lab at the City University of New York (CUNY), where samples from a crucial trial of simufilam were analyzed. The FDA inspectors uncovered significant issues in Wang's practices, including the lack of routine equipment calibration, improper statistical tests, and mishandling of outlier data, leading to an overall rating of eight out of ten in terms of severity.
These findings cast doubt on the reliability of the trial results used by Cassava to promote simufilam's efficacy and advance to phase 3 trials. The company has faced scrutiny and legal actions due to previous concerns about the credibility of Wang's research. Notably, a CUNY panel had raised suspicions of scientific misconduct in Wang's preclinical work, and the FDA inspection report now adds to the skepticism surrounding the drug's development process.
The questionable practices identified in Wang's lab, such as the arbitrary handling of outlier data and lack of proper documentation, raise serious concerns about the integrity of the data used to support simufilam's effectiveness. The FDA report highlighted deficiencies in Wang's adherence to Good Laboratory Practices (GLPs) and the mishandling of crucial samples, leading to doubts about the accuracy and validity of the trial results.
Cassava Sciences has defended Wang's work, stating that the lab was not obligated to follow GLPs for exploratory research, despite the clinical nature of the sample analysis. However, the company's response fails to address the fundamental issues raised by the FDA inspection, indicating a potential gap between regulatory standards and the company's practices.
The FDA findings have reignited calls from critics for the suspension of simufilam trials, citing a lack of rigor and reliability in the data. Neuroscientist Matthew Schrag, among others, has expressed skepticism about the drug's clinical trial results and called for a reevaluation of the program. The FDA's refusal to comment on the impact of the inspection findings on the ongoing phase 3 trials underscores the uncertainty surrounding the drug's future prospects.
Overall, the damning FDA inspection report sheds light on the questionable practices in Wang's lab and raises serious doubts about the validity of the trial results supporting simufilam. The implications of these findings on the regulatory review process and the credibility of Cassava Sciences' Alzheimer's drug development efforts remain to be seen.
Source: https://www.science.org/content/article/damning-fda-inspection-report-undermines-positive-trial-results-possible-alzheimer-s
These findings cast doubt on the reliability of the trial results used by Cassava to promote simufilam's efficacy and advance to phase 3 trials. The company has faced scrutiny and legal actions due to previous concerns about the credibility of Wang's research. Notably, a CUNY panel had raised suspicions of scientific misconduct in Wang's preclinical work, and the FDA inspection report now adds to the skepticism surrounding the drug's development process.
The questionable practices identified in Wang's lab, such as the arbitrary handling of outlier data and lack of proper documentation, raise serious concerns about the integrity of the data used to support simufilam's effectiveness. The FDA report highlighted deficiencies in Wang's adherence to Good Laboratory Practices (GLPs) and the mishandling of crucial samples, leading to doubts about the accuracy and validity of the trial results.
Cassava Sciences has defended Wang's work, stating that the lab was not obligated to follow GLPs for exploratory research, despite the clinical nature of the sample analysis. However, the company's response fails to address the fundamental issues raised by the FDA inspection, indicating a potential gap between regulatory standards and the company's practices.
The FDA findings have reignited calls from critics for the suspension of simufilam trials, citing a lack of rigor and reliability in the data. Neuroscientist Matthew Schrag, among others, has expressed skepticism about the drug's clinical trial results and called for a reevaluation of the program. The FDA's refusal to comment on the impact of the inspection findings on the ongoing phase 3 trials underscores the uncertainty surrounding the drug's future prospects.
Overall, the damning FDA inspection report sheds light on the questionable practices in Wang's lab and raises serious doubts about the validity of the trial results supporting simufilam. The implications of these findings on the regulatory review process and the credibility of Cassava Sciences' Alzheimer's drug development efforts remain to be seen.
Source: https://www.science.org/content/article/damning-fda-inspection-report-undermines-positive-trial-results-possible-alzheimer-s
Comments
Post a Comment