Drugs in Development
ELND005
The small molecule ELND005 is a beta amyloid anti-aggregation agent. In June 2010, a Phase 2 clinical study (study AD201) was completed and topline results were announced on 9 August 2010. Study AD201 was a Phase 2 placebo controlled study in 351 patients with mild to moderate Alzheimer’s disease who received study drug (250mg twice daily; 1,000mg twice daily; 2,000mg twice daily; or placebo) for up to 18 months. The two higher dose groups were discontinued in December 2009.
The study did not achieve significance on co-primary outcome measures (neuropsychological test battery (NTB) and Alzheimer’s Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)). The 250mg twice daily dose demonstrated a biological effect on amyloid-beta protein in the cerebrospinal fluid (CSF), in a subgroup of patients who provided CSF samples. This dose achieved targeted drug levels in the CSF previously associated with therapeutic effects in animal models, and showed some effects on clinical endpoints in an exploratory analysis.
After reviewing the final safety data with the study’s Independent Safety Monitoring Committee, we concluded that the 250mg twice daily dose has acceptable safety and tolerability. We are currently studying development scenarios to advance the compound.
ELND002
We are continuing to develop ELND002, a PEGylated small molecule alpha4 integrin inhibitor for the treatment of MS. Phase 1b/2a clinical trials for ELND002 are ongoing in MS patients and the FDA has granted Fast Track status to develop ELND002 for the treatment of Secondary Progressive MS.
Alzheimer's Immunotherapy (Bapineuzumab, AAB-002, ACC-001)
In September 2009, JANSSEN Alzheimer Immunotherapy, a subsidiary of Johnson & Johnson, acquired substantially all of the assets and rights of Elan related to its Alzheimer's Immunotherapy Program (AIP), including bapineuzumab.
For information about AIP, including clinical trials, please contact:
JANSSEN Alzheimer Immunotherapy (Dublin)
Treasury Building
Lower Grand Canal Street
Dublin 2, Ireland
Telephone: +353 1 448 7811
Fax: +353 1 237 3029
JANSSEN Alzheimer Immunotherapy Research & Development, LLC (South San Francisco)
700 Gateway Blvd
South San Francisco, CA 94080
Telephone: +1 650 794 2500; +1 888 381 4595
Fax: +1 650 794 2504
