March 25 (Reuters) - Cassava Sciences ( SAVA ) said on
Tuesday its Alzheimer's drug simufilam, which has been at the
center of regulatory scrutiny, failed in a second late-stage
study, sending shares of the company down 20% in early trading.
The drug came under close watch after a medical professor
linked to its development was charged with fraud last year.
Neuroscientist Hoau-Yan Wang allegedly submitted false data to
get millions of dollars in public funds for research into the
drug.
Late last year, the company had disclosed plans to stop all
trials of the drug after it failed in the first late-stage study
called ReThink-ALZ. The company said on Tuesday that it will
phase out development programs of the drug by the end of the
second quarter.
Cassava has said that Wang was not involved in the
late-stage trials of simufilam. Previously listed as a co-lead
scientist for simufilam on Cassava's website, Wang's name has
since been removed.
CEO Rick Barry said the company was disappointed that
the results showed no treatment benefit and that the results
were "unambiguous."
The results disclosed on Tuesday are from a trial called
Refocus-ALZ, in which the drug failed to significantly reduce
cognitive decline in patients with mild-to-moderate Alzheimer's
disease.
Simufilam was the only drug that Cassava was developing,
along with a blood-based diagnostic test, called SavaDx, which
is in mid-stage studies for Alzheimer's.
The company reported about $128.6 million in cash and
equivalents as of December 31, 2024.
Cassava and two of its former executives were also
charged by the U.S. Securities and Exchange Commission for
making misleading claims in 2020 about the results from previous
studies of the drug. It paid a $40 million penalty to settle the
allegations.