Genentech's Anti-Amyloid Beta Antibody Gantenerumab Receives FDA Breakthrough Therapy Designation for Alzheimer’s Disease

Today, Genentech, a member of the Roche Group, announced that the U.S. FDA has granted Breakthrough Therapy designation to the investigational anti-β-amyloid antibody therapy gantenerumab for the treatment of Alzheimer’s disease (AD). Gantenerumab is currently being evaluated in Phase 3 clinical trials. According to the press release, it is the first subcutaneously administered anti-β-amyloid antibody therapy to be evaluated in late-stage clinical trials.

Gantenerumab is an investigational IgG1 monoclonal antibody that binds to aggregated forms of β-amyloid, clearing amyloid deposits in the brain, which is one of the hallmark features of Alzheimer’s disease (AD). In multiple clinical trials, gantenerumab significantly reduced amyloid deposits in the brains of patients with AD. Based on these data, the FDA granted gantenerumab Breakthrough Therapy designation.

Based on experience gained from previous clinical trials, Roche has optimized the clinical trial design and is currently evaluating the efficacy of gantenerumab in two global, placebo-controlled Phase 3 clinical trials involving more than 2,000 patients with Alzheimer's disease (AD). These trials are expected to be completed in the second half of 2022.

In addition, Roche is also developing a fusion protein known as the gantenerumab Brain Shuttle system. This protein fuses gantenerumab with an antibody that binds to the transferrin receptor (TfR1). By binding to the transferrin receptor, it facilitates the transport of gantenerumab across the blood-brain barrier into the central nervous system. Phase 1 pharmacokinetic trial results indicate that this system can increase the proportion of the drug entering the cerebrospinal fluid by 6- to 8-fold.

▲Gantenerumab Brain Shuttle technology (Image source: Roche official website)

References:

[1] Ad hoc announcement pursuant to Art. 53 LR: Genentech’s Anti-Amyloid Beta Antibody Gantenerumab Granted FDA Breakthrough Therapy Designation in Alzheimer’s Disease. Retrieved October 8, 2021, from https://www.businesswire.com/news/home/20211008005371/en

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