IBJNews

Potential Alzheimer’s drug fails first of four key trials

Back to TopCommentsE-mailPrintBookmark and Share

Pfizer Inc., Johnson & Johnson and Elan Corp.’s experimental Alzheimer’s treatment failed to improve symptoms of dementia in the first of four pivotal studies testing the drug.

Bapineuzumab, designed to target the brain plaques that serve as a hallmark of Alzheimer’s, didn’t aid cognitive or functional ability in patients who carry a gene, called ApoE4, that makes them more likely to get the disease, Pfizer said Monday in a prepared statement. Doctors now await results from trials in patients without the higher genetic risk.

Bapineuzumab is in a race with a similar product from Indianapolis-based Eli Lilly and Co. to become the first therapy to target a cause for Alzheimer’s, rather than just its symptoms. While patients in the failed study, dubbed 302, have now been taken off the drug, the other trials will continue, New York-based Pfizer said in its statement.

“There was no reason to believe, unless there was a miracle, that this would be positive,” said Rudolph Tanzi, professor of neurology at Harvard Medical School in Boston. “It will only be the results of the non-ApoE4 carriers that will inform us about the future.”

Both bapineuzumab and the Lilly drug work by slowing the production of beta amyloid, the protein that makes up the plaques. Since research began on these drugs, other theories of the disease have developed, including activity by a protein called tau that tangles in the brains of patients.

It’s still too early to determine which therapy may work best to eliminate the disease, researchers said,

“While we are disappointed in the topline results of Study 302, a more complete understanding of bapineuzumab and its potential utility in mild-to-moderate Alzheimer’s disease will be gained,” said Steven Romano, Pfizer’s head of medicine development for primary care, in the statement.

The first Alzheimer’s drugs, should they prove successful, would lead to a market for the treatments worth $20 billion, according to Barbara Ryan, an analyst with Deutsche Bank, in a June note to clients.

The companies are conducting trials in two groups of patients, in four total studies. The data outlined Monday were from U.S. patients with the ApoE4 gene, who tend to show symptoms of Alzheimer’s earlier in life.

Researchers haven’t been optimistic that the drug would be effective in patients with the gene, said Tanzi.

Patients with the Alzheimer’s gene didn’t benefit from treatment in earlier studies, and they were given a lower dose because of side effects, he said in a telephone interview.

The companies will “expedite the completion” of a second study in patients with the gene outside the U.S. That data should come this summer, said Mackay Jimeson, a Pfizer spokesman, and the companies will do additional analyses of patients in the failed study.

Full data are expected in September, when the companies have said they will present findings from people without the ApoE4 gene in Stockholm at the European Federation of Neurological Societies meeting.

“While we are disappointed in the results of this first study, the phase 2 trials suggested that ApoE4 non-carriers may have a better chance of benefiting from bapineuzumab than ApoE4 carriers, and the results of the second study in non-carriers due later this summer will shed more light on this possibility,” J&J spokesman Bill Price said in a statement.

Pfizer decided to announce the trial had failed now because it had patients stop taking the drug and was concerned news would leak out before it could complete other trials, Jimeson said. The companies previously said that they would release results from the two U.S. studies at the same time.

The failure was no surprise, said Mark Schoenebaum, an analyst with ISI Group in New York. “Our current model carries a 25-percent probability of success,” he said in a client note.

The Pfizer-J&J drug and the one from Lilly are based on one of the first research strategies designed to combat the disease.

After autopsies of Alzheimer’s victims showed an accumulation of beta amyloid plaques in their brains, drugmakers began focusing on that as a potential cause. Since then, other contributing factors have surfaced, including the overdevelopment of a different protein, known as tau.

While most of the strategies currently in the third and final stage of testing required for regulatory approval target amyloid, the field is now moving beyond amyloid-only targets, said Maria Carrillo, director of medical and scientific relations for the Alzheimer’s Association.

There are more than 40 different compounds currently in mid-stage tests for the disease, according to an accounting from the association.

“We don’t think amyloid is going to be a magic bullet, but it is important,” Carrillo said in an interview at the association’s annual meeting last week. “This is a maturing field with a variety of approaches, and we’re going to need multiple approaches. We feel very hopeful about the maturation of the field and the variety of approaches in development.”

One main complaint about the current studies with bapineuzumab and Lilly’s drug solanezumab is that they were given to patients who already displayed dementia.

New research shows that amyloid build up begins decades before symptoms start, leaving patients potentially too damaged to benefit from treatment. Studies are now planned to test treatments in people at risk for the disease before signs of dementia appear, based on brain imaging scans, age and genetics.

“We know a heck of a lot more now than we did 15 years ago, when the first studies of bapineuzumab were being designed,” Carrillo said prior to the latest findings being released. “We are slowly moving the needle back in time for these amyloid plaque busters.”
 

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. Uh, sorry Johnnie, but you are incorrect. Despite the assertions by yourself and various defenders and captains, sports attendance is NOT off significantly at most sporting events in the US. Variances in attendance has been in the range of single digits, both + & - for years now. MLB has had most of its best overall attendance nubers in the last decade, and that trend has been consistent for most major sporting events. The number one issue cited by most fans when asked about attendance is the overall cost of attending. The presence of HD and big screen televisions in home doesn't even register, as a factor for not attending an event. VALUE in the product is the key, and apparently is something lacking in the current ICS. What other explanation is there when with what is routinely touted as the "best" racing on the planet, fans are staying away in DROVES. A "close" title battle into the last event at Fontana, with the "cars and stars" of the ICS, and who showed up? MAYBE 8K. Sorry, but HD TV isn't to blame for that kind of fan apathy.

  2. Do you need finance to establish your business ? Are you interested in getting a loan at 3% from our private company? If so please Email: suntrust_oil@blumail.org

  3. If she was worth the $ the public outcry over direct tv dropping them would have kept them on their dishes as we have seen with other companies. I too quit watching channel 13 after she showed up since I left channel 8 because of her all show rather than production results. When Randy on 8 corrected her she had a big head and incorrectly challenged his correction for pronunciation of a city. Other antics while she matures was too much for me with her very inaccurate forecasts. All the forecasters were predicting rain until Thursday except Chris. They predicted sunny on Thursday but instead of rain until Thursday upon which the sun would finally make it out in full glory Chris was right on the money just as I too predicted looking at the radar on weather.gov. One thing I love about Angela is the fear you can see in her every time it thunders in the winter. It far exceeds the entertainment value of her body language (high heel noise drags, depression, etc) when her forecasts are so incorrect. Her hair stands on end, you have to see it!!!

  4. Good Day, Apply For A Loan I am Mr Fernadez Antonio, a private Loan lender and a cooperate financial for real estate and any kinds of business financing. I also offer Loans to individuals, Firms and cooperate bodies at 3% interest rate We offer any kind of loans. email us via fernadezloaninvest@outlook.com LOAN APPLICATION FORM First name:......................... Middle name:......................... Last name:........................................ Date of birth (yyyy-mm-dd):....................... Gender:........................................... Marital status:................................... Total Amount Needed............................... Loan Duration.................................... Address:.......................................... City:............................................. State/province:................................... Zip/postal code:.................................. Country:.......................................... Phone:............................................ Fax:.............................................. Mobile/cellular:.................................. Monthly Income.................................... Occupation:....................................... Best Regard, Mr Fernadez Antonio.

  5. i will love to share my testimony to you all the people in world i got married to my husband about 2 year ago we start having problems at home like we stop sleeping on the same bed,fighting about little things he always comes home late at night,drinking too much and sleeping with other women out side i have never love any man in my life except him. he is the father of my child and i don't want to loose him because we have worked so hard together to become what we are and have today .few month ago he now decided to live me and the kid,being a single mother can be hard sometimes and so i have nobody to turn to and i was heart broken.i called my mom and explain every thing to her,my mother told me about DR.okoro how he helped her solve the problem between her and my dad i was surprise about it because they have been without each other for three and a half years and it was like a miracle how they came back to each other. i was directed to DR. okoro on his email:okorospell@gmail.com and explain everything to him,so he promise me not to worry that he will cast a spell and make things come back to how we where so much in love again and that it was another female spirit that was controlling my husband he told me that my problem will be solved within two days if i believe i said OK So he cast a spell for me and after two days my love came back asking me to forgive him i Am so happy now. so that why i decided to share my experience with every body that have such problem contact Dr okoro the great spell caster on his email addresses spellcasterforlove@outlook.com

ADVERTISEMENT