Otsuka's drug for Alzheimer's disease agitation fails in late stage study

Otsuka Holdings

13/02/2024 24:04

Feb 13 (Reuters) - Japan's Otsuka Holdings  4578.T  said
on Tuesday that its experimental drug failed to meet a primary
late-stage trial goal in treating agitation associated with
dementia due to Alzheimer's disease. 
    The treatment, AVP-786, failed to achieve statistically
significant difference on the primary trial goal testing the
efficacy of the candidates, compared to placebo. 
    The company said there were four deaths reported in the
trial, including one in the low dose group and three in the
placebo group.
    Agitation associated with dementia has a large impact on the
quality of life for the patients, and is reported in about half
of all patients with Alzheimer's dementia, said Otsuka, mainly
engaged in the medical and nutraceuticals related business. 
    Despite the disappointing results, Otsuka said it planned to
analyze the full data set to determine the future potential of
AVP-786. 
    Otsuka said the full study results are not yet available and
intends to submit the trial results for scientific publication
at a later date.
    The company also expects to record an impairment loss, of
about 115 billion yen ($770.00 million) in AVP-786, in the
fourth quarter of this fiscal year. 
    Alzheimer's disease, a progressive brain disorder is the
most common cause of dementia, a serious condition that can
impair an individual's ability to function independently.


($1 = 149.3500 yen)

 (Reporting by Pratik Jain in Bengaluru; Editing by Rashmi Aich)
 ((Pratik.Jain@thomsonreuters.com;))