The Protein That Promised a Cure - and Vanished from the Data
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The Protein That Promised a Cure - and Vanished from the Data
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Hope turned to doubt when pixel-for-pixel repeats in lab images and a single lab's dominance over the evidence underpinned a drug that enrolled over 400 people with Alzheimer's - so what happened to the missing verification that should have stopped human trials? Who knew about the data shifts, and why did a failed biomarker readout get reversed months later?
In this episode, we follow the path from a scaffolding protein called filamin A to a compound taken into human trials, tracing publications, funding, and the contested biomarker results to ask whether the scientific basis for simufilam was ever independently confirmed.
Person: Hoau-Yan Wang
Person: Lindsay Burns
Company: Cassava Sciences (formerly Pain Therapeutics)
Drug: simufilam (PTI-125)
Enrollment: more than 400 people by August 2022
- In 2012 Wang and Burns published a key paper linking filamin A to Alzheimer's in the Journal of Neuroscience.
- In 2017 a follow-up study in Neurobiology of Aging reported that PTI-125 improved pathology in transgenic Alzheimer's-model mice.
- In 2018 the NIH awarded funding to Cassava Sciences for early human trials of simufilam.
- By March 2020 open-label human studies had begun with blood biomarker measurements taken from enrolled patients.
- In May 2020 a Phase IIb biomarker analysis failed to support the hypothesized effects, but in September 2020 Cassava announced that an outside lab had produced improved biomarker results.
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