SEC investigates Alzheimer’s drug developer Cassava Sciences

Cassava CEO Remi Barbier denied allegations that the company manipulated research The US Securities and…

Cassava CEO Remi Barbier denied allegations that the company manipulated research

The US Securities and Exchange Commission is reportedly investigating claims that Alzheimer’s drug developer Cassava Sciences manipulated research results using Photoshop to alter images in a scientific paper.

Cassava, based in Austin, Texas, revealed in a regulatory filing on Monday that it is ‘cooperating’ with ‘certain government agencies’ that have asked it to provide corporate information and documents.

The SEC is one of those agencies, according to a Wall Street Journal report citing people familiar with the matter.

The unusual claims against Cassava were first brought forward in August, when two doctors who had bet against the company’s stock filed a citizen petition with the Food and Drug Administration claiming an article in the Journal of Neuroscience had been manipulated.

Cassava furiously denounced the allegations, which CEO Remi Barbier called false and financially motivated. 

Two doctors who had bet against the company's stock were the first to claim that 'western blot' images such as this one in a research paper had been altered with Photoshop

Two doctors who had bet against the company’s stock were the first to claim that ‘western blot’ images such as this one in a research paper had been altered with Photoshop

An SEC spokesperson and Cassava executive did not immediately respond to inquiries from DailyMail.com on Wednesday morning.

Cassava, which began trading under its current name in 2019, has no commercial drugs and hasn’t reported any product revenue since 2013.

Nevertheless, it has been one of the hottest stocks of 2021, rising as much as 1,570 percent from the beginning of the year before the allegations first emerged and the shared plunged. 

Hoau-Yan Wang co-authored the research papers in question

Hoau-Yan Wang co-authored the research papers in question

The company’s stock was down 25 percent in morning trading on Wednesday, but still up more than 550 percent year-to-date. 

Cassava’s experimental drug, called Simufilam, aims to restore a protein called filamin A that is misshapen in the brains of Alzheimer’s patients, according to the Journal.

The company claims that in its contorted state, the protein triggers a toxic buildup of another protein called amyloid, which is a classic hallmark of Alzheimer’s.

The allegations against the company were first made by two physicians who disclosed they had shorted the company’s stock: David Bredt, a biotech entrepreneur and former neuroscience research chief at Johnson & Johnson and Eli Lilly, and Geoffrey Pitt, a cardiologist and professor at Weill Cornell Medicine. 

The two doctors claimed that Cassava, in research articles authored by Hoau-Yan Wang, a Cassava adviser and CUNY associate medical professor, manipulated images depicting western blots.

David Bredt

Geoffrey Pitt

David Bredt (left) and Geoffrey Pitt (right) took positions against Cassava’s stock before going public with their allegations against the company

Cassava's stock soared before the claims were made public in August. It is still up more than 550 percent so far this year

Cassava’s stock soared before the claims were made public in August. It is still up more than 550 percent so far this year

Western blots are a common lab technique for detecting proteins in samples of tissue or blood, and typically appear as a series of parallel bars or bands, separated by their molecular weights.

An internal review by the Journal of Neuroscience found an instance of duplicated images in the paper, and issued a correction on November 10, which said the error didn’t affect the article’s conclusions.

However, other independent reviews claim to have discovered evidence of image manipulation.

Elisabeth Bik, a microbiologist and image-manipulation consultant who says she doesn’t have any position in Cassava stock, said in a Medium post that she agrees with concerns raised about the company’s research.

Bik pointed out an number of unexplained irregularities in research papers that Wang had authored for Cassava. 

Elisabeth Bik, a microbiologist and image-manipulation consultant, pointed out images that she says show telltale signs of alteration, marking bands that appear identical above

Elisabeth Bik, a microbiologist and image-manipulation consultant, pointed out images that she says show telltale signs of alteration, marking bands that appear identical above

‘At least five other articles from the Wang lab at CUNY appear to show image concerns as well,’ wrote Bik. ‘These papers might not be directly related to Simufilam research, but they are still indirectly connected to Cassava Sciences or its drug candidates.’ 

Barbier, the Cassava CEO, has denied the allegations in multiple public statements.

‘I’ve never doubted the integrity of our people or science,’ Barbier said on November 4. 

‘We remain focused on conducting a Phase 3 clinical program of simufilam in people with Alzheimer’s disease. It’s an important endeavor, notwithstanding pundits who may be louder than they are learned. We’ll stay the course until our job is done,’ he added. 

Bik and other scientists noted that it’s possible that Cassava’s drug candidate may still be effective, even if the research was manipulated.

‘The drug might work great,’ Bik told the Journal.