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Elan, Transition to advance ELND005

August 10, 2010 12:40 AM UTC

Elan Corp. plc (NYSE:ELN) and partner Transition Therapeutics Inc. (TSX:TTH; NASDAQ:TTHI) plan to advance ELND005 into Phase III testing despite data showing that it missed the co-primary endpoints in the Phase II AD201 trial to treat Alzheimer's disease (AD). ELND005 did not significantly improve cognitive and functional measures for up to 18 months as determined by the NTB and ADCS-ADL scales, respectively, vs. placebo. However, the partners said that twice-daily 250 mg ELND005 demonstrated a biological effect on beta amyloid in cerebrospinal fluid (CSF) in a subgroup of patients who provided CSF samples (n=20), as well as "some effects on clinical endpoints" in an exploratory analysis of the trial. The data included 166 patients in the modified intent-to-treat (mITT) population.

The final analysis excluded all 180 patients from the 1,000 and 2,000 mg twice-daily ELND005 cohorts. Last year, the partners discontinued the high-dose groups based on an analysis by an independent safety monitoring committee that showed a greater rate of serious adverse events, including nine deaths, in the cohorts. Rates of serious adverse events for 250 mg ELND005 and placebo were 21.6% and 13.3%, respectively, while rates of serious adverse events that were considered treatment related were 2.3% and 2.4%, respectively. ELND005 is a small molecule that disaggregates beta amyloid fibrils. ...