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▎The content team editor of WuXi AppTec today, Genentech, a subsidiary of Roche, announced that the US FDA has granted an anti-β-amyloid antibody therapy gantenerumab breakthrough therapy designation for the treatment of Alzheimer’s disease (AD )
.
Gantenerumab is currently being tested in phase 3 clinical trials
.
The press release states that it is the first subcutaneous injection of anti-β-amyloid antibody therapy to be evaluated in late-stage clinical trials
.
Gantenerumab is an IgG1 monoclonal antibody under development.
It combines with the aggregate form of β amyloid to remove amyloid deposits in the brain, which is one of the hallmark features of the brain of AD patients
.
In multiple clinical trials, gantenerumab significantly reduced amyloid deposits in the brains of AD patients
.
Based on these data, the FDA granted gantenerumab breakthrough therapy designation
.
Based on the experience gained in previous clinical trials, Roche has optimized the design of the clinical trial and is currently testing the efficacy of gantenerumab in two global, placebo-controlled phase 3 clinical trials involving more than 2,000 AD patients
.
These two trials are expected to be completed in the second half of 2022
.
In addition, Roche is also developing a fusion protein called gantenerumab brain shuttle system
.
This protein fuses gantenerumab with an antibody that binds to the transferrin receptor (TfR1).
It can bind to the transferrin receptor to help gantenerumab cross the blood-brain barrier and enter the central nervous system
.
Phase 1 pharmacokinetic test results show that this system can increase the proportion of drugs entering the cerebrospinal fluid by 6-8 times
.
▲Gantenerumab brain shuttle technology (picture source: Roche official website) "For more than 10 years, we have been committed to advancing AD research and our research therapy gantenerumab
.
" Roche Chief Medical Officer and head of global product development Dr.
Levi Garraway said, "This The grant of breakthrough therapy designation has strengthened our confidence in gantenerumab
.
It may become the first subcutaneous injection therapy for Alzheimer's disease, making it possible for patients to receive treatment at home
.
"Reference: [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:// The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
.
Gantenerumab is currently being tested in phase 3 clinical trials
.
The press release states that it is the first subcutaneous injection of anti-β-amyloid antibody therapy to be evaluated in late-stage clinical trials
.
Gantenerumab is an IgG1 monoclonal antibody under development.
It combines with the aggregate form of β amyloid to remove amyloid deposits in the brain, which is one of the hallmark features of the brain of AD patients
.
In multiple clinical trials, gantenerumab significantly reduced amyloid deposits in the brains of AD patients
.
Based on these data, the FDA granted gantenerumab breakthrough therapy designation
.
Based on the experience gained in previous clinical trials, Roche has optimized the design of the clinical trial and is currently testing the efficacy of gantenerumab in two global, placebo-controlled phase 3 clinical trials involving more than 2,000 AD patients
.
These two trials are expected to be completed in the second half of 2022
.
In addition, Roche is also developing a fusion protein called gantenerumab brain shuttle system
.
This protein fuses gantenerumab with an antibody that binds to the transferrin receptor (TfR1).
It can bind to the transferrin receptor to help gantenerumab cross the blood-brain barrier and enter the central nervous system
.
Phase 1 pharmacokinetic test results show that this system can increase the proportion of drugs entering the cerebrospinal fluid by 6-8 times
.
▲Gantenerumab brain shuttle technology (picture source: Roche official website) "For more than 10 years, we have been committed to advancing AD research and our research therapy gantenerumab
.
" Roche Chief Medical Officer and head of global product development Dr.
Levi Garraway said, "This The grant of breakthrough therapy designation has strengthened our confidence in gantenerumab
.
It may become the first subcutaneous injection therapy for Alzheimer's disease, making it possible for patients to receive treatment at home
.
"Reference: [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:// The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
