Wall Street darling Cassava Sciences is under fire as scientists question trial irregularities


A small biotech company that saw its stock evaluation rocket after revealing it had developed a drug that could potentially reverse the cognitive decline of Alzheimer’s – which would be the first of its kind – is now facing allegations of manipulating or falsifying data.

Cassava Sciences, an Austin, Texas-based company, revealed last year that its drug simufilam showed incredible promise in early trials – and it was rewarded with incredible stock growth, peaking at $135 per share after spending years under the $5 mark. 

But then the skeptics arrived, with now multiple experts pointing out irregularities in published data, even making major accusations that the company and associated researchers had manipulated data.

The company is now facing an investigation from the Securities and Exchange Commission (SEC), and has had some of its trial data either rescinded or marked by journals as potentially manipulated.

This is the second major controversy to strike a newly developed Alzheimer’s drug in the last 12 months, with Biogen’s Aduhelm also receiving a wave of scrutiny after it received approval from the Food and Drug Administration (FDA) last year.    

The biotech company Cassava is facing multiple allegations that it and associated researchers have manipulated data and doctored photos related to trials for its Alzheimer’s drug, simufilam

Cassava's stock price experienced rampan growth after it revealed promising data from trials of its Alzheimer's drug. It has since floundered amid mounting allegations of data manipulation

Cassava’s stock price experienced rampan growth after it revealed promising data from trials of its Alzheimer’s drug. It has since floundered amid mounting allegations of data manipulation

The allegations are centered around two researchers, Hoau-Yan Wang of CUNY, in New York City, and Cassava’s own Lindsay Burns, who had previously published two studies related to the brain.

Late last year the Journal of Neuroscience issued an ‘expression of concern’ regarding data published by the two researchers at the end of 2021, reports Retraction Watch.

This means that the editors of the paper have doubts over the accuracy of the data published. 

Last month, another study authored by the pair that is key to Cassava’s findings was hit with an ‘expression of concern’ from Neurobiology of Aging.

What is Alzheimer’s?

Alzheimer’s disease is a progressive, degenerative disease of the brain, in which build-up of abnormal proteins causes nerve cells to die.

This disrupts the transmitters that carry messages, and causes the brain to shrink. 

More than 5 million people suffer from the disease in the US, where it is the 6th leading cause of death, and more than 1 million Britons have it.

WHAT HAPPENS?

As brain cells die, the functions they provide are lost. 

That includes memory, orientation and the ability to think and reason. 

The progress of the disease is slow and gradual. 

On average, patients live five to seven years after diagnosis, but some may live for ten to 15 years.

EARLY SYMPTOMS:

  • Loss of short-term memory
  • Disorientation
  • Behavioral changes
  • Mood swings
  • Difficulties dealing with money or making a phone call 

LATER SYMPTOMS:

  • Severe memory loss, forgetting close family members, familiar objects or places
  • Becoming anxious and frustrated over inability to make sense of the world, leading to aggressive behavior 
  • Eventually lose ability to walk
  • May have problems eating 
  • The majority will eventually need 24-hour care   

 Source: Alzheimer’s Association

 

Last year, New York City-based law firm Labaton Sucharow filed a citizen’s petition  to the FDA saying it had ‘grave concerns about the quality and integrity of the laboratory-based studies surrounding this drug candidate and supporting the claims for its efficacy,’ Retraction Watch reports.

The law firm is representing investors who had shorted the company’s stock, and would financially benefit from the company’s price decreasing.

Only weeks late, PLoS One, a journal which has been criticized by many experts for not have a particularly rigorous peer-review process, retracted five papers from Wang.

The New York Times reports that CUNY has launched an investigation into Wang, which is still ongoing.

The Wall Street Journal reported in November of last year, before the first expression of concern was issued,  the the SEC had launched an investigation into the company, as it potentially defrauded investors by using manipulated trial data to inflate its stock price.

Cassava received funding from the National Institutes of Health to develop the drug, and is now facing an investigation from that agency as well, the Times reports.

The drug was apparently able to reverse the cognitive decline associated with Alzheimer’s in two-thirds of patients. No other drug on the market is able to do that..

Only one drug may have the ability to even slow down the cognitive decline, Biogen’s Aduhelm, which many also doubt even works, has been rejected for Medicare coverage in the U.S. and whose developers have also been accused of improper data practices.

Experts noticed that some fluctuations in biomarkers reported in the studies did not make sense, and cast doubts over the study’s findings.

‘That type of discrepancy really raises questions in terms of the rigor as well as the reliability of these results,’ Dr William Hu, a neurologist at Rutgers University, told the Times.

Another study found that the drug could restore the shape of some proteins in the brain, which Dr Thomas Südhof, a neuroscientist at Stanford University, said ‘there’s just no possibility, no rational way this could happen,’ per the Times.

Elisabeth Bik, an expert on image manipulation who has also found other studies that have used doctored photos, reported that she had found signs of Cassava doctoring visuals in its study.

The company’s stock has suffered as a result of the allegations. It was as high as $90.91 per share in early November, before the WSJ report was released, and has since cratered to $22.46 as of closing bell Tuesday.

Read more at DailyMail.co.uk