UPDATE: Cassava Sciences responds to claims that data is manipulated and defies logic

[ad_1]

It appears that Alzheimer’s drug developer Cassava Sciences was advised to check with its partner, Quanterix Corp., before referring to the digital health solutions company in its defense against the claims made. earlier this week by shareholder rights law firm Labaton Sucharow in a citizens’ petition to the U.S. Food and Drug Administration (FDA).

Texas-based Cassava, whose mission is to develop innovative treatments for neurodegenerative diseases, is developing Simufilam, an investigational small-molecule drug that aims to restore normal form and function of the altered scaffold protein, filamin A (FLNA), in the brain.

In a strong defense released Wednesday morning, Cassava called the claims false and misleading and responded to each in detail. Among these was the claim that all of the basic science supporting Simufilam, including biomarker data, was generated by Dr Lindsay Burns, Cassava Senior Vice President of Neuroscience and Scientific Advisor Dr Hoau- Yan Wang.

In response, Cassava told shareholders that the plasma data for p-tau was reportedly generated by Lynn A. Brunelle of Quanterix Corp., which she then presented at the Alzheimers Association’s 2021 international conference.

In a statement released Friday morning, Quanterix denied being directly involved in the generation of this data.

Cassava previously hired the Quanterix Accelerator lab to perform sample testing based on blind samples provided by Cassava, the statement said. Quanterix or its employees did not interpret the test results or prepare the data tables presented by Cassava at the Alzheimers Association (AAIC) International Conference in July 2021 or otherwise.

The companies now appear to be on the same page, as Cassava also released a statement on Friday confirming that Quanterix’s sole responsibility with regard to this clinical study was to perform sample testing.

The saga began when Jordan Thomas, partner and chair of the whistleblower representation practice at Labaton Sucharow, called on federal regulators to end clinical trials on Cassavas, suggesting that some of the company’s results appeared to show signs. data manipulation.

“This report raises concerns about the quality and integrity of the laboratory studies surrounding this drug candidate,” wrote Thomas. The volume of problematic material uncovered in publicly available sources indicates that a thorough audit would likely reveal scientific misconduct and manipulation of important additional data.

Thomas further stated that the methodology allegedly used in these experiments defies logic.

On Wednesday, the cassava rocked out.

As a scientific company, we stand for facts that can be evaluated and verified, said Rémi Barbier, President and CEO of Cassava. It helps people make informed choices. It is important for stakeholders to separate fact from fiction, which is why we want to tackle the allegations head-on.

Barbier told BioSpace he had “never heard of a citizens’ petition for a pre-phase III drug, specifically a drug candidate that appears to be as safe as simufilam.”

Among the myriad of alleged problems the company encountered, two stood out in the areas of Western blot analysis and biomarker data.

In his official response, Cassava refuted what he called the fictitious claim that the extensive use of Western transfer analysis is fundamental to cassava science research and therefore suspect.

The company responded by stating that Western blotting is a standard laboratory technique used around the world to detect a protein of interest. Cassava further refuted claims that the data appeared overexposed and highly processed, signaling image manipulation, saying anything less would show evidence of inexperience.

On Tuesday, Cassava said it had reached an agreement with the FDA to specialize the protocol for its Phase 3 studies of oral simufilam for the treatment of patients with Alzheimer’s disease.

The company also reaffirmed the initial guidance it had received from the agency to move Simufilam forward into a pivotal six-month Phase III trial that it plans to launch in the second half of 2021.

[ad_2]