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

By Thomson Reuters Feb 12, 2024 | 6:06 PM

(Reuters) – Japan’s Otsuka Holdings 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)