A Controversial Alzheimer’s Drug Has Gone Down in Flames

A biotech firm’s try to supply a remedy for Alzheimer’s illness is now prone to finish in disastrous trend. This week, Cassava Sciences reported the failure of its newest Part III trial of its experimental drug, simufilam—a drug that allegedly obtained so far as it did because of poorly achieved and probably fraudulent analysis surrounding it.

On Monday, Cassava Sciences announced the topline outcomes of its year-long randomized, managed trial of simufilam, which examined whether or not the twice-daily capsule might be efficient at slowing down the development of dementia in folks with gentle to average Alzheimer’s. Simufilam failed to satisfy any main or secondary targets of the examine, basically which means it carried out no higher than placebo throughout the board. The outcomes look to be the ultimate nail within the coffin for Cassava’s growth of the drug, which has lengthy been marred by allegations of fraud dedicated each by affiliated researchers and Cassava executives.

Specifically, outside scientists and federal agencies have accused Hoau-Yan Wang, a Metropolis College of New York (CUNY) professor and former Cassava advisor, of repeatedly committing scientific misconduct throughout his analysis on simufilam for the corporate, which can have gone so far as manipulating pictures and skewing or outright fabricating outcomes to make the drug look extra promising. Whereas Wang could have been accountable for probably the most egregious acts of dangerous science tied to simufilam, although, critics have additionally argued that Cassava misled the general public itself.

Earlier this September, the corporate agreed to pay greater than $40 million to the Securities and Trade Fee to settle costs associated to its dealing with of the Part II trials on simufilam, whereas Wang agreed to pay $50,000 in fines. In keeping with the SEC, Wang was capable of determine whether or not a few of the sufferers have been taking a placebo or the experimental drug (in pivotal scientific trials, scientists are usually stored at the hours of darkness about this distinction, because it might bias their evaluation); Wang then allegedly used this info to make simufilam look far more efficient at bettering biomarkers associated to Alzheimer’s illness. The SEC additional alleged that Cassava and its former CEO, Remi Barbier, and its former Senior Vice President of Neuroscience, Lindsay Burns, made deceptive statements primarily based on the Part II outcomes to its traders. In a single alleged occasion, Cassava claimed that simufilam considerably improved sufferers’ episodic reminiscence, whereas failing to reveal that this enchancment was solely present in a subset of sufferers chosen by Burns, and that no such enchancment was seen within the full set of affected person knowledge.

In settling with the SEC, Cassava, its executives, and Wang didn’t admit or deny the allegations made towards them. Following the SEC’s costs, Cassava claimed that it cooperated with the investigation and that it was taking steps to forestall any additional analysis points; the corporate additionally acknowledged that Wang had zero enter on the Part III trials of simufilam. However critics have alleged that the misconduct and inflated claims surrounding simufilam date back far earlier than the Part II trials, suggesting that the drug by no means labored as meant. Given these newest findings, the critics look to have been proper.

Cassava appears to have staked its future on the success of simufilam, because it has no different drug candidates within the pipeline—a future that’s now in peril, to say the least. Within the wake of the drug’s failure, the corporate introduced that it might be ending its second Part III trial of simufilam early, although it reportedly nonetheless plans to launch the info from each trials to the general public. As for Wang, his authorized troubles aren’t essentially over. Earlier this June, a federal grand jury within the District of Maryland indicted Wang for allegedly defrauding the U.S. Nationwide Institutes of Well being (NIH) of roughly $16 million in federal grant funds, which seems to be tied to his Alzheimer’s analysis.