Genentech has dosed the first patient in a Phase 2 clinical trial for Alzheimer's disease (AD) with an anti-Tau monoclonal antibody known as RO7105705. Upon the dosing of the first patient in the Phase 2 clinical trial, AC Immune becomes eligible to receive a milestone payment of CHF 14 million.
AC Immune SA, a Swiss-based, clinical stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that Genentech, a member of the Roche Group, has dosed the first patient in a Phase 2 clinical trial for Alzheimer's disease (AD) with RO7105705. This investigational medicine was discovered and humanized as part of the company's collaboration with Genentech. Upon the dosing of the first patient in the Phase 2 clinical trial, AC Immune becomes eligible to receive a milestone payment of CHF 14 million, which is expected to be paid in the fourth quarter of 2017. This will be the third milestone payment under the 2012 strategic collaboration and licensing agreement with Genentech for anti-Tau antibodies for the treatment of AD and other neurodegenerative diseases. AC Immune also has a licensing agreement for the anti-Abeta antibody crenezumab, which is in Phase 3 clinical studies being conducted by Genentech.
Prof. Andrea Pfeifer, CEO of AC Immune, commented: "We are delighted that our collaboration partner Genentech is taking this anti-Tau antibody into Phase 2. Tau pathology is widely recognized to be closely associated with cognitive decline and neurodegeneration in Alzheimer's disease and other tauopathies." She continued "Our unique understanding of the pathology of misfolding proteins is exemplified by the depth of our pipeline and the range of our collaborations."
About the Phase 2 clinical trial
The Phase 2 clinical trial is conducted by Genentech and will enroll 360 patients to assess the safety, tolerability and efficacy of the anti-Tau monoclonal antibody RO7105705 in people with prodromal-to-mild AD. Participants will receive one of three active doses or placebo for 72 weeks, followed by a 96-week optional open label extension. Primary endpoints include safety measures and the composite functional and cognitive endpoint CDR (Clinical Dementia Rating scale) sum-of-boxes score. Change from baseline in Tau pathological burden is an important exploratory endpoint.
(Press release)
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