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:
 
thisissue1-092914.jpg 092914

Subscribe to IBJ
  1. Here are a few candidates for this new group, "ripped from the headlines." First up, that bizzaro State Senator Brent Waltz; secondly, the unethical Todd Huston, and his contractual arrangements scheme; Finally, but not least of all, the dishonorable Eric Turner. What sayeth you Greg Zoeller?

  2. Good day. I can't hide this great testimony that take place in my life I will love everyone to know it and be partaker that is why I always place it on answer, I am Mrs,Natalie Cuttaia by name, I live in Texas, United State Of America, I want to thank (Mr.Bruce Brandon) for his kindness upon my family life. I never knew that there is still nice lender like this on internet and earth here. Just some Months Back, I was in search for a loan of $100,000,00 as I was running out of money for feeding and rent. I was scammed $6,800 Dollars and I decided not to involve my self in such business again but a Friend of my introduced me to a loan firm due to my appearance and doings. And I told him that I am not interested of any loan deal anymore but he told me that there is still a nice lender who he will recommend me to, and I made a trial and I am most grateful lucky am I today, I was given a loan amount of $100,000.00usd, by this great Company (Bruce Brandon Loan Company) managed by (Mr.Bruce Brandon) If you are in need of a genuine or legit loan or financial assistance and you can be reliable and trusted of capable of paying back at the due time of the funds I will advice you to, contact him via: ( bruce.brandon071@gmail.com ) And you will be free from scams in the internet. All thanks to Mr.Bruce Brandon You are the one who remove me and my family out of poverty. The reason why i am doing this is that, i promise Mr.Bruce Brandon that if i truly got my loan, i will advertize his company and bring customers to his company. Contact him via ( bruce.brandon071@gmail.com )for the Loan you have been looking for..

  3. Hello, We are firm Organization formed to help people in needs of helps,such as financial help. So if you are going through financial difficulty or you are in any financial mess,and you need funds to start up your own business,or you need loan to settle your debt or pay off your bills,start a nice business, or you are finding it hard to obtain capital loan from local banks,contact us today via email mrsroseberrywilkinsfunds.usa@gmail.com So do not let these opportunity pass you by because Jesus is the same yesterday, today and forever more. Please these is for serious minded and God fearing People. Your Name: Loan Amount: Loan Duration: Valid Cell Phone Number: Thanks for your understanding to your contact as we Await Regards Management Email:mrsroseberrywilkinsfunds.usa@gmail.com

  4. The question is, where could they build a new stadium? It seems in the past year, all the prime spots have been spoken for with potential projects. Maybe in the industrial wasteland area a block past Lucas Oil? I think it needs to be close to the core, if a new stadium is built.

  5. Aldi is generally a great shopping experience. Still, I'm sure YOU wouldn't want to shop there, which I consider a positive.

ADVERTISEMENT