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Elan Phase III plans for Alzheimer's drug survive Phase II flop

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Elan/Transition Therapeutics plan to continue developing the Alzheimer's candidate ELND005 (scyllo-inositol), provided they can find a partner, despite missing co-primary cognitive and functional endpoints in a Phase II dose-ranging study. "Based on the preponderance of evidence from both biomarker and clinical data, and after extensive discussions with experts in the field, Elan and Transition Therapeutics intend to advance ELND005 into Phase III development," Elan announced Aug. 17. The 351-patient, placebo-controlled AD201 Phase II trial was the first study of ELND005 in AD patients. Elan terminated the two highest dose arms, 1,000 and 2,000 mg twice daily, in December 2009 due to an imbalance in serious adverse events, including death. The decision to move forward rests on data from the 88 patients in the remaining treatment arm (250 mg twice-daily), who the company said "showed some effects on clinical endpoints in an exploratory analysis." Additionally, Elan added, the 250 mg twice daily dose "demonstrated a biological effect on amyloid-beta protein in the cerebrospinal fluid" in a subgroup of patients who provided CSF samples. ELND005 is thought to inhibit amyloid-beta protein aggregation in the brain. The amyloid hypothesis in Alzheimer's disease has taken significant hits in recent years with the clinical failure of beta amyoid-focused drugs, most recently Lilly's semagacestat (see related story, "1Lilly's Semagacestat Is Latest Alzheimer's Drug To Fail; Is Class At Risk?")

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