Date: 2015-07-23
Type of
information: Initiation of development program
phase: 3
Announcement: initiation of development program
Company: Roche (Switzerland) AC Immune (Switzerland)
Product: anti-Abeta antibody MABT5102A (crenezumab)
Action
mechanism:
- monoclonal antibody. MABT5102A (crenezumab) is a fully humanized IgG4 monoclonal antibody to Abeta that binds both monomeric and oligomeric forms of Abeta, inhibits Abeta aggregation, and promotes Abeta disaggregation. MABT5102A was discovered and humanized by AC Immune through its proprietary SupraAntigen technology. The drug candidate was discovered by AC Immune. In 2006 AC Immune closed an exclusive out-licensing agreement for its anti-Abeta program with Genentech, under which Genentech develops the anti-Abeta antibody for the treatment of Alzheimer´s Disease. Genentech has full ownership and global responsibility for clinical development, manufacturing and commercialization of the antibody, including all regulatory activities. In return, AC Immune received an upfront payment, a milestone payment when the first patient was dosed under the Phase I clinical trial, and now another payment upon the start of Phase II. In addition AC Immune obtained funding through a research collaboration that was successfully concluded after three years in 2009. The contract provides potential revenues of over $ 300 million for AC Immune through payments upon successful completion of clinical and regulatory milestones in Alzheimer´s disease and additional applications. Additionally, upon commercialization of a product AC Immune will receive royalties.
Disease: prodromal-to-mild Alzheimer’s disease
Therapeutic
area: Neurodegenerative diseases
Country: Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Republic of Korea, Lithuania, Mexico, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, UK, USA
Trial
details:
- This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild Alzheimer’s disease. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (q4w) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. (NCT02670083)
Latest
news:
- *• On July 23, 2015, AC Immune announced that its partner Genentech, a member of the Roche Group, has decided to move crenezumab into phase III clinical development in people with prodromal*-to-mild Alzheimer’s disease. Crenezumab was discovered by AC Immune and licensed to Genentech in 2006; under the terms of the agreement AC Immune will receive an undisclosed milestone payment.
In 2014 Genentech disclosed data from phase II studies. ABBY (cognition study, 431 patients) and BLAZE (biomarker study, 91 patients) showed potential clinical activity in the mild patient subset treated with the higher IV dose (15mg/kg). The milder patient subset in ABBY (MMSE 22-26) exhibited a 35.4 percent reduction in cognitive decline
(p=0.036), measured by the 12-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog12). Those data were replicated in the mild patient subset (MMSE 20-26) of BLAZE with a 52 percent reduction in cognitive decline (p=0.29). A positive trend in reduction in functional decline was observed in both studies. The analysis of the PET data with white matter reference suggest a reduction of amyloid accumulation. One case of ARIA-E (asymptomatic amyloid-related imaging abnormalities; sulcal effusion – or a buildup of fluid in the grooves of the brain) was observed in a person who received IV crenezumab in the ABBY study. No cases of ARIA-E were reported in the ABBY placebo arm, nor in either arm of the BLAZE study.
Is
general: Yes
