BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

[Teezer]

BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS FROM PHASE 1B STUDY OF INVESTIGATIONAL ALZHEIMER’S DISEASE TREATMENT ADUCANUMAB (BIIB037) AT 2015 AD/PD™ CONFERENCE

Treatment with aducanumab produced a dose- and time-dependent reduction of amyloid plaque in the brain. Amyloid plaque is believed to play a key role in the development of the symptoms of AD. In exploratory analyses, a dose-dependent, statistically significant effect of slowing clinical decline was observed on the Mini Mental State Examination (MMSE) and Clinical Dementia Rating (CDR) scales.

“This is the first time an investigational drug for Alzheimer’s disease has demonstrated a statistically significant reduction on amyloid plaque as well as a statistically significant slowing of clinical impairment in patients with prodromal or mild disease,” said Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen Idec. “Based on these results, we are advancing the aducanumab clinical program to Phase 3 with plans to initiate enrollment later this year.”

Summary from Business Insider:

When the drug was tested at a high dose, it showed a 71% reduction in the plaque after 54 weeks compared to the control drug. Investors had been expecting a 30% reduction, according to TheStreet's Adam Feuerstein. These percentages are measured by the Clinical Dementia Rating the industry uses.

[Julie G]

Ah, I'd been waiting for this one- Thanks, Teezer. Very encouraging. This is the first time reducing amyloid has been correlated with improvements in cognition. Fingers and toes crossed that further testing reveals more of the same. Very good news!

[LanceS]

Seems like it slows progression. Mentioned 41% (55% APOE4) who had some type of brain swelling (company thinks a reduction in dose may help them), 50% (35% of APOE4) of whom dropped from the study. Even at 60% (45% APEO 4) (not counting the brain swelling staid in study pop - which would make it 80%,81%) addressable that is incredible. Still a long road but may help some folks in early stages.

Can't believe I didn't back up the truck on the stock... whoops!

Combine this with Bredesen, MB, KD, etc, etc and I wonder if this doesn't become reverses cognition declines for some (although disease likely still progresses). Seems like a pretty shocking positive development in AD treatment. Getting this with another as yet undiscovered drug might become a longer term hope.

[J11]

Where is everyone? This is massive!

Alzheimer's has destroyed my family over the last fifty years. There has been ongoing caregiving for family members with extreme dementia.
Life has been about caregiving not living.

Until today we were anticipating the emergence of cognitive impairment in another generation. Our whole life would have been defined by neuro-degenerative illness. We have been constantly monitoring developments in dementia research for twenty years and today we have the best news ever reported for Alzheimer's disease. These results are impressive.

Biogen has added 50 billion dollars of market capitalization with their AD product. This is the scale of money that can really move forward clinical care for patients. It would not be unreasonable if they were to start dosing their product in healthy people well before the onset of AD. The market for such a product would be very large.


This changes the expected trajectory of our family members. These family members will be able to access BIIB037 years before the buildup of amyloid. We feel so fortunate.

Virtual party anyone?

[KatieS]

It's expected to be approved in 2018. If all goes well in the larger trial, maybe like AIDS drugs, it will be fast-tracked.

[J11]

I had not seen the reference to 2018, though that would be great.

It might make quite a bit of sense if the phase 1 trial that is still recruiting were allowed to continue to recruit and grow into a mini-phase 3.
There are likely now a substantial number of people who would love to sign up for that trial. Why should we wait for the phase 3s to start later this year? The phase 2 trial has been ongoing since October 2012. Biogen now has a market capitalization of $50 billion based on its Alzheimer pipeline alone.

[Julie G]

Keep Lance's warnings in mind. It is most effective in higher doses and E4 carriers tended to display brain swelling at higher doses Researchers are already surmising that our population may need lower doses... Perhaps restrained enthusiasm for now? Still EXCITING!

[SusanJ]

J, I hear you. There are many folks who are needing help now, and especially in families where we've had to deal with care taking.

Would be great to know if they have any theories about what causes the edema...

[J11]

ARIA (edema) has been seen in all of the antibody trials. A level of comfort might have developed that this side-effect is generally manageable.

There is now a huge amount of money on the table to help move everything ahead.

[ApropoE4]

And another one:

http://www.alzheon.com/?page_id=280

ALZ-801 shows promise as a new treatment approach to Alzheimer’s disease designed to enhance efficacy beyond cholinesterase inhibitors with the following attributes:

Achieve or surpass 2-point cognitive improvement on ADAS-cog that tramiprosate has demonstrated in ApoE4 positive Alzheimer’s disease subjects
Achieve or surpass 4-point cognitive improvement on ADAS-cog that tramiprosate has demonstrated in Alzheimer’s disease subjects homozygous for ApoE4 gene
Improve oral absorption through reduced metabolism and minimized pharmacokinetic variability
Improve gastrointestinal safety and tolerability (reduced nausea and vomiting)
Improved pharmacokinetic profile that enables once a day dosing
Confirm excellent long term safety and toxicology in clinical and preclinical studies
Strong intellectual property protection worldwide