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Lundbeck-Otsuka Alzheimer's Candidate Fails Phase III Trial

06:44 EDT 23 Sep 2016 | Genetic Engineering News

Lundbeck has acknowledged that the Alzheimer’s candidate idalopirdine, being developed through a partnership with Otsuka Pharmaceutical, has failed its first Phase III trial by failing to show efficacy in patients with mild to moderate forms of the disease.

Both dosages of idalopirdine used in the STARSHINE trial missed the study’s primary endpoint of a reduction in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score when added to donepezil.

The drug also missed STARSHINE’s secondary endpoints by failing to show significant improvement over placebo, Lundbeck said, adding that the drug was safe and well tolerated. The company announced topline results but did not disclose detailed data.

The results contrasted with positive Phase II results reported in 2013 for the candidate in combination with donepezil for 24 weeks.

“The phase II data were very encouraging but unfortunately, these [Phase III STARSHINE] data fai

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