Drugs

Cassava Stops Controversial Alzheimer’s Drug Developoment

Cassava Sciences says it is discontinuing the development of its Alzheimer’s disease (AD) drug simufilam after announcing disappointing topline data from the Phase 3 ReThink-ALZ study in mild-to-moderate AD patients. In the study, data show that the drug did not meet any of the pre-specified co-primary, secondary and exploratory biomarker endpoints. “The co-primary endpoints were the change in cognition and function from baseline to the end of the double-blind treatment period at week 52, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to placebo,” the company says.

A related Phase 3 study, ReFocus-ALZ, is also being discontinued , the company says. “The complete 52-week dataset will be available from the study along with a large portion of 76-week data,” it says. “We intend to report detailed analyses of both studies in the future.” Simufilam is described as a small molecule drug candidate that targets the filamin A protein.

Last month, the journal Science and other FDA watchers called on the agency to place a clinical hold on simufilam following a recent $40 million settlement with the U.S. Securities and Exchange Commission (SEC) related to misleading statements made about the results of a previous clinical trial. The SEC settlement came on the heels of a Science report earlier this year (see story) on FDA’s concerns about the results of tests conducted in a City University of New York laboratory run by pharmacologist Hoau-Yan Wang on the Cassava drug. The article detailed findings from an FDA inspection that found Wang never calibrated his equipment or completed verification experiments to ensure his tests were accurate, sensitive, and conducted with appropriate precision.

As part of the SEC action, the government charged Wang with manipulating clinical trial results. “Wang received information that unblinded him to some aspects of the Phase 2 clinical data, which he used to identify about a third of the patients enrolled in the trial,” it contended. “Using information that unblinded him to aspects of the trial data, Wang was able to manipulate the data to create the appearance that the drug had caused dramatic improvements in biomarkers associated with Alzheimer’s disease, such as total tau and phosphorylated tau, which are common indicators of neurodegeneration in Alzheimer’s patients.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome