Biogen May Be The Only Legitimate Hope For Bringing An Alzheimer’s Drug To Market
Summary
Biogen has set the state to potentially bring an FDA approved treatment out to early stage patients with Alzheimer’s.
An interim analysis of a phase 1b study and a long-term study shows that increased doses reduce the amount of amyloid plaque in patients with Alzheimer’s.
Biogen has established two phase 3 studies to confirm its positive findings from the phase 1b and long-term study.
The Alzheimer’s market is expected to reach $14.8 billion by 2026.
Some caution is warranted as Eli Lilly also used a monoclonal antibody to reduce amyloid plaque and was unsuccessful in its phase 3 trial for Alzheimer’s.
Biogen (BIIB) is currently testing its drug aducanumab in a phase 3 study treating patients with early Alzheimer’s disease. That’s because it and most other pharma companies weren’t able to achieve success in Alzheimer’s patients that had already progressed to an advanced form of the disease. The good news is that Biogen’s program is still standing. The same can’t be said for many of the other pharmaceutical companies that have attempted to bring an Alzheimer’s disease from testing to market.
Biogen did achieve some positive trends in an interim analysis it performed in a phase 1b trial in patients with early stage Alzheimer’s disease. Just this past year in November of 2017 Biogen reported that aducanumab helped reduce amyloid plaques in Alzheimer’s patients who gradually received an increase in doses. This data was presented at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting, Boston, November 1 – 4 of 2017. There were two pieces of data reported from the phase 1b study. The first set of data came from patients who were gradually increased in doses over a 24 month period, and another set of data showing patients who received fixed doses over a 36-month period. The fixed doses in the trial were: 3 mg/kg, 6 mg/kg or 10 mg/kg of aducanumab. The most important knowledge that Biogen has gained from the phase 1b trial and the long-term study is that aducanumab was shown to reduce amyloid plaques in patients with early stage Alzheimer’s disease.
