Date: 2018-07-17
Type of
information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: Roche (Switzerland)
Product: crenezumab
Action
mechanism:
- monoclonal antibody. 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. The antibody was discovered and humanized by AC Immune through its proprietary SupraAntigen technology.
- 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: Alzheimer's disease
Therapeutic
area: Neurodegenerative diseases
Country: Argentina, Australia,Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Greece, Guatemala, Hungary, Israel, Italy, Japan, Republic of Korea, Mexico, Norway, Peru, Poland, Portugal, Serbia, South Africa, Spain, Sweden, Switzerland, Taïwan, Turkey,UK, USA
Trial
details:
- CREAD 2 is a randomized, double-blind, placebo-controlled, parallel-group study. It will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (q4w) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153). (NCT03114657)
- Roche/Genentech is currently evaluating the clinical efficacy and safety of crenezumab in two Phase 3 clinical trials, CREAD 1 and 2, in 750 participants each trial with prodromal or mild Alzheimer's disease, which started in the first quarter of 2016 and the first quarter of 2017, respectively. CREAD 1 was fully recruited in the fourth quarter of 2017.
Latest
news:
- • On July 17, 2018, AC Immune announced that the second Phase 3 (CREAD 2) clinical trial of crenezumab, AC Immune's anti-Abeta antibody candidate for treatment of Alzheimer's disease, conducted by its partner Genentech has completed global recruitment.
- • On February 28, 2017 , AC Immune announced that its partner Genentech, member of Roche group, has decided to start a second Phase 3 clinical trial of the Alzheimer’s therapy crenezumab, an anti-Abeta antibody.
- This new trial CREAD2 will recruit 750 patients with prodromal or mild Alzheimer’s disease. This new trial complements the current Phase 3 CREAD1 trial of 750 participants with prodromal or mild Alzheimer’s disease, expected to read out in 2021.
- AC Immune will not receive any milestone payments for the start of this second Phase 3 trial since the company already received a milestone payment when the CREAD1 trial started.
Is
general: Yes
