Replies to post #211 on Biogen Inc (BIIB)

[DewDiligence]

That article is from 2015.

[MinnieM]

In a post further down you say toxicity is an issue. Perhaps not. The sample size was too small to know for sure. The article you posted was published by John Carroll | Jul 22, 2015 6:32am

Biogen was hoping that the efficacy of the drug would be amped up for the 6-mg dose, which had not yet matured in March, with the better tox profile allowing for a safer drug. The spokesman for Biogen noted that the worsening ARIA-E rate among non-ApoE4 carriers was the result of one case.

"When we start breaking down the treatment groups, we are getting into very small sample sizes, and those data reflect one additional patient in the additional 6 months we are reporting," he noted.

Biogen's two Phase III's have already begun, with investigators recruiting 1,350 patients for a 5-year study, according to ClinicalTrials.gov. Analysts, though, expect to see data around 2018 that would help determine where Biogen is headed with this drug.

There are two ongoing ph III trials with Aducanumab. Based on the large number enrolled and the start date of the trials we'd have heard of serious toxicity issues by now.

The Engage and Emerge trials are being done on a global scale. Qualified patients will participate in one or the other, but, not both. Go to this link if you have a family member you'd like to get into the trial. https://www.aducanumabclinicaltrials.com/about-these-studies

221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (ENGAGE) Study Start: August 2015 178 locations
https://clinicaltrials.gov/ct2/show/NCT02477800?term=aducanumab&rank=5&submit_fld_opt=
Estimated Enrollment: 1350
Study Start Date: August 2015
Estimated Study Completion Date: February 2022
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)


221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (EMERGE) Study Start: September 2015 173 locations
https://clinicaltrials.gov/ct2/show/NCT02484547?term=aducanumab&rank=4&submit_fld_opt=
Estimated Enrollment: 1350
Study Start Date: September 2015
Estimated Study Completion Date: February 2022
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

It's going to be a few years before we get results on efficacy from these ph III's.



Ph I side effects

Amyloid-related imaging abnormalities (ARIAs) were monitored with four MRI scans, read both locally and by a central reader at an imaging CRO. Side effects included headache, diarrhea, and dizziness. They were mild or moderate, some possibly related to the study drug but not to the dose.

Aducanumab | ALZFORUM
http://www.alzforum.org/therapeutics/aducanumab

There is no ph II listed on clinical trials.gov

Only ph I and ph III...

I don't hold long or short here... just watching Alzheimer's trials with hope that one of them come through with some meaningful therapies.








In Reply to 'Cbdpotential'
http://www.fiercebiotech.com/r-d/updated-a-setback-biogen-s-mid-range-dose-of-aducanumab-flops-alzheimer-s-study