BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

Alzheimer's, cardiovascular, and other chronic diseases; biomarkers, lifestyle, supplements, drugs, and health care.
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Re: BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

Postby ApropoE4 » Wed Mar 25, 2015 9:24 am

I don't think at this point anyone particularly believes Ab plaques are the single cause of AD, and many think they're not a cause at all. It's possible some benefits will come from reducing the inflammation they cause, but without treating tau pathology and other toxic E4 mediated processes, this will at best buy a little bit of time.

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Re: BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

Postby J11 » Wed Mar 25, 2015 4:00 pm

The Biogen results are impressive.

They appear to have stopped progression of AD in patients for one year. This trial has been going on for three, so it will be interesting to see how long they will be able to extend such results.

It is surprising that they were able to show stabilization that late into the illness. It surely raises the question how much further into the disease progress it might be effective. Given that people with these antibodies never AD we can assume that giving the antibodies earlier will be effective.

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Re: BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

Postby Julie G » Sat Jul 11, 2015 1:21 pm

With the Alzheimer’s Association International Conference/AAIC, almost underway in Washington, D.C. (July 18-23,) many researchers are keeping information under wraps until it can be presented. Bloomberg, however, is reporting hints that Biogen may be soon reporting disappointing data.

Biogen Plunges; Alzheimer’s Drug Data Pose Risk
http://www.bloomberg.com/news/articles/ ... poses-risk
Biogen Inc. dropped the most since April after Cowen & Co. said the biotechnology company’s stock price faces risk from data coming later this month on a drug to treat Alzheimer’s disease… Biogen declined 2.8 percent to $388 at 11:09 a.m. in New York. It fell as much as 4.4 percent earlier, the biggest intraday decline since April 24. It was among the 10 biggest decliners on the Standard & Poor’s 500 Index.

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Re: BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

Postby ApropoE4 » Fri Jul 17, 2015 2:41 am

Juliegee wrote:With the Alzheimer’s Association International Conference/AAIC, almost underway in Washington, D.C. (July 18-23,) many researchers are keeping information under wraps until it can be presented. Bloomberg, however, is reporting hints that Biogen may be soon reporting disappointing data.

Biogen Plunges; Alzheimer’s Drug Data Pose Risk
http://www.bloomberg.com/news/articles/ ... poses-risk
Biogen Inc. dropped the most since April after Cowen & Co. said the biotechnology company’s stock price faces risk from data coming later this month on a drug to treat Alzheimer’s disease… Biogen declined 2.8 percent to $388 at 11:09 a.m. in New York. It fell as much as 4.4 percent earlier, the biggest intraday decline since April 24. It was among the 10 biggest decliners on the Standard & Poor’s 500 Index.


I read somewhere that their head of R&D just "left".

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Re: BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

Postby J11 » Sat Jul 25, 2015 9:18 pm

We have overlooked something: The Biogen Phase 3s have already started!

https://clinicaltrials.gov/ct2/show/NCT ... mab&rank=3
https://clinicaltrials.gov/ct2/show/NCT ... mab&rank=4

The latest results were something of a disappointment. When one reads through the Biogen press report one gets a bad feeling.

In the only dose shown to have a benefit (10 mg/kg), 55 % of APOE4s developed ARIAs. In fact, 35% of the APOE4s at this dose discontinued treatment. Others had to have their dose reduced. We have seen early stage trials in AD report positive numbers on a hand full of patients only to publish negative results in phase 3. Each of the 4 dosing arms only had about 30 patients and the combined placebo only had 40 patients.

The recently reported 6 mg/kg arm had an associated placebo group of only 10 patients! I wonder why a combined placebo group was not used for the 6 mg/kg arm. It would be interesting to know whether this placebo was in line with expected results or was an outlier.

These results are a concern. They had a small number in each arm and they then looked at the APOE subgroups, while at the same time there was substantial side effects and discontinuation of treatment especially (with the APOE4s).

http://media.biogen.com/press-release/c ... -disease-t

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Re: BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

Postby ApropoE4 » Sun Jul 26, 2015 9:24 pm

It's a dead end, J11. There's no way a drug with ED and MTD so close together is going to make it except if it's a last-resort cancer drug.

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Re: BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

Postby J11 » Mon Aug 10, 2015 8:50 pm

This seems important to pass along.

The FDA seems to be shifting now towards looking for big effects in antibodies than in arguing yea or nay whether such effects are
real. The argument now appears to have changed. This is what many of us have waited years to see. However, small the effects might be
increasing thought leaders accept that these antibodies do have a positive effect. Once this has been clearly established AD will be on the same path to success as the cholesterol lowering drugs were on years ago. If all you need to do is lower the biomarker ( amyloid) [and not the cognitive markers], then the bar for success will have been greatly lowered. Pharmas will actually realize that making money in AD drugs is doable.


http://www.alzforum.org/news/conference ... zumab-well

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Re: BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

Postby J11 » Thu Feb 11, 2016 4:05 pm

I am starting to like how the amyloid lowering story is advancing.

Biogen reported positive cognition results when lowering amyloid by 10-30%.
They have now moved the product into phase 3s.

Bexarotene moved down amyloid by 10% with 4 weeks treatment in a few APOE e3s.
A patient report has appeared of cognitive improvement with Bexarotene treatment in an epsilon 3,4.

Large scale trials are now deep into phase 3s that can reduce amyloid levels over 90%.
A recent report found that cranial radiation greatly reduced amyloid levels in mice (by over 70%).
http://www.ncbi.nlm.nih.gov/pubmed/26838263

What is especially exciting is that a body of research is accumulating that supports the notion that
amyloid lowering has a cognitive benefit. As soon as this can be more firmly established, it might no longer
be necessary to test for cognitive endpoints. All that would be needed is to show that amyloid levels were
moved down. Avoiding cognitive testing would make clinical trials less complex and cheaper.
We now appear to be on the same clinical trajectory as that followed by cholesterol lowering drugs several
years ago.

I wonder whether a meta analysis could be done that looked at all Alzheimer's trials that have been able to lower
amyloid levels using various therapeutics. Each of the trials by themselves might not be showing the signal while
combining the trials together might.

Also thought it was somewhat interesting to think what might happen if one of the trials currently underway showed
safe and robust amyloid lowering, though no cognitive benefits in say a mild-moderate AD population. Might be another
Viagra incident {During the initial Viagra trial the patients did not want to give up their medicine because though it might
not have reduced their cardiovascular risk, it enhanced other aspects of their life).

With the Alzheimer trial, people might demand access to amyloid lowering drugs even without an efficacy signal in the current trials,
simply because it has already been shown that lowering amyloid by 40% over a lifetime results in dramatic reduction in dementia risk
(the APP mutation that lowers amyloid). The consumer market for such a product would be overwhelming.

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Re: BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

Postby Julie G » Sat Feb 13, 2016 9:26 am

What about all of the trials in which lowering amyloid worsened cognition? I'm not seeing a convergence here... I suspect the real amyloid connection has yet to be elucidated.

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Re: BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

Postby J11 » Sat Feb 13, 2016 11:22 am

Yes, it is true that all the numbers have not yet lined up, though it is very exciting that at least now we are within sight of
them. A range of amyloid lowering medications (some that reduce amyloid by a massive amount) are in clinical trials.

The clinical results for these medications could have several important implications.
For instance, as I noted above a safe and effective amyloid lowering drug would be a very attractive option for the
consumer lifestyle management community. The APP mutation which significantly lowered amyloid levels greatly
changed cognitive ability even in normal agers.


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