Cassava Sciences has been informed by the Journal of Prevention of Alzheimer’s Disease that there is no evidence to support the charges, the company said Thursday.
After months of allegations about data manipulation of western blot images used in a paper to support its Alzheimer’s disease asset simufilam, Cassava Sciences has been informed by the Journal of Prevention of Alzheimer’s Disease that there is no evidence to support the charges, the company said Thursday.
Texas-based Cassava claimed vindication regarding the 2020 paper supporting simufilam that was co-authored by company personnel and Hoau-Yan Wang, a key scientific collaborator. The company said it received notification from the publication on August 15. In that missive, the journal reportedly said it could not find “convincing evidence of manipulation of data or intent to mislead” in the paper titled “PTI-125 Reduces Biomarkers of Alzheimer’s Disease in Patients.” The publication said it was taking no action regarding the published paper, Cassava stated.
Cassava Chief Executive Officer Remi Barbier, who has boisterously defended the company, said from the onset of claims made against Cassava that the allegations of research misconduct are false statements meant to hurt the company.
“From the onset, I have said that allegations of research misconduct are false, and for good reason – I see no supporting evidence for the allegations,” Barbier said in a statement issued Thursday.
Shares of Cassava were up 17% in Thursday morning trading following the company’s announcement.
The allegations made about the western blot image in the JPAD article, as well as simufilam-supporting articles in other publications co-authored by Wang have plagued Cassava for months. It began with the retraction of five papers in PLoS One due to “serious concerns about the integrity and reliability of the results.” Following those retractions, other publications conducted their own investigations, such as Neurobiology of Aging. That examination of the papers authored by Wang did not find evidence of data manipulation but did list methodological errors. The journal Neuroscience also investigated claims but found no evidence of data manipulation.
“I’m hopeful that written pronouncements from neutral and independent science experts will help close the chapter of baseless attacks against our science. At some point it becomes irrational for our detractors to repeat over and over again the same old tired mantra of data manipulation,” Barbier said.
Cassava noted in its announcement that a related investigation by academic authorities at The City University of New York remains ongoing.
An article published earlier this year by The New York Times highlighted the charges against the images in the company’s published journal articles. It also included criticisms of Cassava Sciences’ research on simufilam, an oral small molecule drug candidate that is designed to restore the normal shape and function of altered filamin A (FLNA) protein in the brain. Barbier also defended his company against the criticisms in the Times. In a rebuttal of the claims made in the report Barbier said the article was “one-sided” because it only used sources who were critical of the Texas-based company. Two of the critics relied upon by the Times were behind a Citizen’s Petition filed with the U.S. Food and Drug Administration that aimed to suspend the company’s clinical research into simufilam. That petition was denied earlier this year after Neuroscience announced that it could find no evidence to support claims of data manipulation.
Simufilam is being assessed in two Phase III studies for Alzheimer’s disease, RETHINK-ALZ and REFOCUS-ALZ. As of June 30, the company reported it had cash and cash equivalents of $197.2 million, with no debt.
