On January 30, 2019, we announced
that Roche, the parent of our collaboration partner, Genentech, is discontinuing the CREAD 1 and CREAD 2 (BN29552 and
BN29553) Phase III studies of crenezumab in people with prodromal to mild sporadic AD. The decision came after an interim
analysis conducted by the IDMC indicated that crenezumab was unlikely to meet its primary endpoint of change from baseline in
Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score. This decision was not related to safety of the investigational product.
No safety signals for crenezumab were observed in this analysis and the overall safety profile was similar to that seen in
Crenezumab continues to be studied in a
preventive trial of cognitively healthy individuals in Colombia with an autosomal dominant mutation who are at risk of developing
familial AD (fAD), under the Alzheimer’s Prevention Initiative (API), which began in 2013. This study will determine if treating
people carrying this mutation with crenezumab prior to the onset of AD symptoms will slow or prevent the decline of cognitive and
functional abilities. This study is in collaboration with the Banner Institute and is funded by the National Institute on Aging.
In March 2019, the Company and Biogen decided
not to extend their collaboration agreement into a fourth year per the contract and conclude in April 2019 within the original
three-year term of the agreement.