Roche has stopped Phase III studies of a molecule called crenezumab in people with Alzheimer’s disease which was discovered by AC Immune. It was the most advanced product candidate in AC Immune’s pipeline.
AC Immune SA announced today that Roche, the parent company of its collaboration partner, is discontinuing the CREAD 1 and CREAD 2 (BN29552 and BN29553) Phase III studies of the investigational anti-beta-amyloid molecule, crenezumab, in people with prodromal to mild sporadic Alzheimer's disease (AD). The decision came after an interim analysis conducted by the Independent Data Monitoring Committee (IDMC). The IDMC analysis indicated that crenezumab was unlikely to meet its primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score.
Crenezumab continues to be studied in a landmark 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.
Prof. Andrea Pfeifer, CEO of AC Immune, said: "We are extremely disappointed about the outcome of the Phase III CREAD 1 interim analysis and we also would like to thank patients and caregivers for their participation. We continue to be optimistic about the potential future of crenezumab as we await the outcome of the Colombian API study to prevent AD symptoms in patients with familial AD to see if the antibody treatment may provide disease-modifying effects in patients with early-onset disease."
Andrea Pfeifer continued, "We remain committed to our on-going pre-clinical and clinical candidates targeting Tau and neuro-inflammation to treat Alzheimer's disease, neuro-orphan diseases and Parkinson's disease, which are partnered with five leading pharmaceutical partners, including Roche's subsidiary Genentech."
AC Immune's two proprietary technology platforms create antibodies, small molecules and vaccines designed to address a broad spectrum of neurodegenerative indications, such as Alzheimer's disease (AD). The company's pipeline features nine therapeutic and three diagnostic candidates - with five products in clinical trials.
(Press release - SK)
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