Gantenerumab is an investigational IgG1 antibody designed to block certain forms of amyloid beta and eliminate brain amyloid plaques, a pathological marker for Alzheimer's disease
Roche’s subsidiary Genentech has received the US Food and Drug Administration (FDA) breakthrough therapy designation for its anti-amyloid beta antibody therapy Gantenerumab to treat Alzheimer’s disease (AD).
Gantenerumab is an investigational IgG1 antibody designed to block certain forms of amyloid beta and eliminate brain amyloid plaques, a pathological marker for AD.
The company said that the drug has significantly reduced the brain amyloid plaques in the SCarlet RoAD and Marguerite RoAD open-label extension studies (OLEs), and in the DIAN-TU-001 study.
Genentech global product development head and chief medical officer Levi Garraway said: “We look forward to delivering a comprehensive and robust data set that furthers our collective understanding of this devastating disease.
“This breakthrough therapy designation reinforces our confidence in gantenerumab, which would be the first subcutaneous medicine for the treatment of Alzheimer’s disease with the potential for at-home administration.”
The FDA breakthrough designation is based on data from the ongoing SCarlet RoAD and Marguerite RoAD OLEs, along with other studies.
Outcomes from the two RoAD studies have been incorporated into the optimised design of Phase 3 GRADUATE 1 and GRADUATE 2 trials.
The two parallel trials are designed to evaluate the safety and efficacy of gantenerumab in more than 2,000 participants over two years, in more than 30 countries.
Also, the GRADUATE trials will investigate the effect of gantenerumab on amyloid load and downstream biomarkers of disease progression in people with early AD.
AD is a progressive and fatal brain disease characterised by a decline in memory, language, and other thinking skills along with changes in mood and behaviour.
Furthermore, Genentech is studying the anti-amyloid beta antibody therapy in Open RoAD and GRADUATION trials, along with an exploratory OLE of DIAN-TU-001, in AD.