A biotech companionship ’s attempt to produce a treatment for Alzheimer ’s disease is now probable to end in disastrous manner . This hebdomad , Cassava Sciences reported the failure of its late Phase III trial of its experimental drug , simufilam — a drug that allegedly receive as far as it did due to ill done and potentially fallacious research surrounding it .
On Monday , Cassava Sciencesannouncedthe topline results of its year - long randomized , controlled trial of simufilam , which tested whether the twice - daily oral contraceptive could be in effect at slowing down the advance of dementedness in hoi polloi with mild to moderate Alzheimer ’s . Simufilam give out to conform to any primary or secondary goal of the field , essentially meaning it performed no better than placebo across the board . The results look to be the net nail in the coffin for Cassava ’s development of the drug , which has long been marred by allegations of faker committed both by affiliated investigator and Cassava executives .
In especial , remote scientistsandfederal agencieshave accused Hoau - Yan Wang , a City University of New York ( CUNY ) prof and former Cassava consultant , of repeatedly committing scientific wrongful conduct during his research on simufilam for the company . This misconduct may have rifle as far as Wang manipulating images and skewing or unlimited fabricating results to make the drug search more promising . While Wang may have been responsible for the most gross acts of speculative science tied to simufilam , though , critics have also reason that Cassava misled the populace itself .
Simufilam, taken as a pill twice a day, failed to show it was better than placebo at slowing down the progression of Alzheimer’s in a large-scale Phase III trial.© vorDa via Getty
originally this September , the companyagreedto pay more than $ 40 million to the Securities and Exchange Commission to settle charge related to its manipulation of the Phase II trial run on simufilam , while Wang agreed to give $ 50,000 in fine . According to the SEC , Wang was able to identify whether some of the patients were look at a placebo or the experimental drug ( in pivotal clinical tribulation , scientist are usually keep in the darkness about this distinction , since it could predetermine their analysis ) ; Wang then allegedly used this data to make simufilam attend much more effective at improving biomarkers touch on to Alzheimer ’s disease . The SEC further allege that Cassava and its former chief operating officer , Remi Barbier , and its former Senior Vice President of Neuroscience , Lindsay Burns , made misleading statements free-base on the Phase II answer to its investors . In one aver instance , Cassava claim that simufilam significantly improved affected role ’ episodic store , while failing to unwrap that this improvement was only found in a subset of patients selected by Burns , and that no such improvement was seen in the full set of patient information .
Cassava seems to have staked its time to come on the achiever of simufilam , since it has no other drug nominee in the line — a future that ’s now in riskiness , to say the least . In the backwash of the drug ’s failure , the company announced that it would be terminate its 2nd Phase III test of simufilam early , though it reportedly still plan to unloosen the information from both trials to the populace . As for Wang , his effectual troubles are n’t of necessity over . Earlier this June , a federal lordly panel in the District of MarylandindictedWang for allegedly defrauding the U.S. National Institutes of Health ( NIH ) of just about $ 16 million in federal subsidisation store , which looks like tie to his Alzheimer ’s research .
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