MW Sage Therapeutics to end Huntington's disease trial after key therapy fails again

By Ciara Linnane

Dalzanemdor has also failed as treatment for cognitive impairment in Alzheimer's disease and Parkinson's disease

Sage Therapeutics Inc.'s stock (SAGE) fell 2% early Wednesday after the company said it would cease the development of a treatment for cognitive impairment associated with Huntington's disease after a failed trial.

It was the third failed trial for the therapy, called dalzanemdor, which also failed to meet its goals in a Phase 2 trial as a treatment for mild cognitive impairment and mild dementia in Alzheimer's disease, as the company announced in October.

In April, the company said dalzanemdor had failed to achieve statistically significant improvement in the treatment of mild cognitive impairment in Parkinson's disease.

The latest Phase 2 trial sought to evaluate dalzanemdor as a therapy for Huntington's disease patients, but failed to show a statistically significant difference versus placebo at day 84. The trial also failed to meet secondary endpoints.

"We are disappointed by the results of the DIMENSION Study, especially for the individuals and families affected by Huntington's disease who have long awaited new treatment options," Sage Chief Executive Barry Greene said in prepared remarks.

In October, Sage said it was cutting about 33% of its workforce as part of an overhaul of its business and pipeline that's expected to extend its cash runway.

For more, see: Sage Therapeutics' stock falls 4.7% as biotech unveils plan to cut 33% of workforce

The company is now focusing its efforts on the launch of zurzuvae, a treatment for postpartum depression. Zurzuvae was the first oral medication to win regulatory approval as a treatment for postpartum depression in August 2023.

Sage's stock has fallen 77% in the year to date, after a series of setbacks.

In July, the company and partner Biogen Inc. $(BIIB)$ said they would abandon any further development of their experimental treatment for essential tremor, a neurological condition that causes involuntary shaking.

A Phase 2 study of the drug, SAGE-324, found no statistically significant differences between patients' response to any dose of the investigational treatment versus a placebo.

The S&P 500 has gained 24% in the year to date.

-Ciara Linnane

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November 20, 2024 07:35 ET (12:35 GMT)

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