Another setback in the industry's push to develop a disease-modifying therapy for the treatment of Alzheimer's disease.
According to Fortune magazine, the historic failure rate for Alzheimer’s therapies is 99.6 per cent.
Biogen and Eisai announced late last week they would discontinue the development of aducanumab. The decision was based on the results of an analysis conducted by an independent data monitoring committee. The committee found the ENGAGE and EMERGE studies were unlikely to meet their primary endpoint. The trials included several Australian sites.
Aducanumab was one of several potential therapies the companies have in development for Alzheimer's disease. They said they would continue to work on the other potential treatments, including BAN2401.
The announcement wiped almost 30 per cent from the Biogen share price. The announcement was released while the Japanese sharemarket was closed but pre-market trading suggests Eisai could fall over 15 per cent.
Aducanumab is a monoclonal antibody that works by removing a toxic plaque in the brain called amyloid. The build-up of amyloid is thought to be a cause of Alzheimer’s disease.
Aducanumab is not dissimilar to other treatments whose development has also been halted in recent years. However, Biogen and Eisai took a somewhat different approach to the development of aducanumab, trialling the therapy in patients in the very early stages of Alzheimer's disease.
The companies said they would also discontinue another phase 2 safety study (EVOLVE) and a long-term extension of the phase 1b study. "Initiation of the aducanumab Phase 3 secondary prevention trial will be assessed while the data from ENGAGE and EMERGE are further evaluated," it said.
“This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience. We are incredibly grateful to all the Alzheimer’s disease patients, their families and the investigators who participated in the trials and contributed greatly to this research,” said Biogen CEO Michel Vounatsos.
“Biogen’s history has been based on pioneering innovation, learning from successes and setbacks. Driven by our steadfast commitment to patients and our strong business foundation, we will continue advancing our pipeline of potential therapies in Alzheimer’s disease and innovative medicines for patients suffering from diseases of high unmet need.”