IBJNews

Lilly: Alzheimer's patients on failed drug didn’t improve

Back to TopCommentsE-mailPrintBookmark and Share

Eli Lilly and Co. said patients with Alzheimer’s disease whose conditions worsened upon taking the experimental drug semagacestat didn’t improve after dosing was halted.

Lilly stopped development of the pill in August after data showed it harmed patients instead of helping them. The Indianapolis-based company gathered information on the failed compound for 32 weeks after patients stopped taking the treatment. Lilly presented the data Tuesday at the Alzheimer’s Association International Conference in Paris.

“We wanted to understand what happened,” Eric Siemers, senior medical director for Alzheimer at Lilly, said in an interview at the conference. “Even though semagacestat didn’t work, we feel we moved the field forward in terms of our understanding of how you develop these compounds.”

Semagacestat, which was in the last of three stages of testing usually needed for U.S. regulatory approval, was designed to block an enzyme called gamma secretase that’s tied to production of beta amyloid plaque, considered by researchers to be a main contributor to Alzheimer’s. More insight on semagacestat may clarify whether other gamma secretase inhibitors, such as Bristol-Myers Squibb Co.’s avagacestat, pose the same problem, said Marc Goodman, an analyst at UBS AG in New York.

Even seven months after patients stopped the use of semagacestat, they still had more trouble with thinking, remembering and mental functioning than those who didn’t receive the medication, Lilly said Tuesday. Patients who had taken the drug didn’t worsen further, the company said.

“The cognitive worsening wasn’t reversible,” Siemers said. “On the other hand, the lines didn’t continue to diverge. It wasn’t that we initiated some cascade that didn’t stop after you stopped the compound.” The exact reasons for which semagacestat failed are unclear and may never be known, Siemers said. The dosing was right, he also said.

About 36 million people worldwide suffer from the memory-robbing condition, according to the Alzheimer’s Association. By 2050, that number is expected to double.

The disease, first described in 1906 by the German doctor Alois Alzheimer, destroys brain cells and makes it difficult for patients to think, remember and function. Current therapies, including Forest Laboratories Inc.’s Namenda and Pfizer and Eisai Co.’s Aricept, address only Alzheimer’s symptoms and don’t cure or slow it.

“If the semagacestat data points to a significant class effect, we would see risk to Bristol’s compound,” currently in mid-stage testing, Goodman wrote in a July 14 note to clients.

William Thies, chief medical and scientific officer at the Alzheimer’s Association, doesn’t think the Bristol-Myers compound will necessarily be affected by the findings.

“We’ll see whether their gamma secretase is more selective,” Thies said in an interview before Lilly presented the data. “Typically, when new drug classes are opened up, the first agents tend to be dirty and we recognize side effects that we can attack by changing the molecule slightly.”

Siemers said he couldn’t comment on the other gamma secretase inhibitors in development as he didn’t know them well enough.

Lilly is running two final-stage trials of another Alzheimer’s treatment, solanezumab, which works against beta amyloid by trying to clear it through the bloodstream. The U.S. drugmaker needs new products to replace its schizophrenia treatment Zyprexa and other of its top-selling medicines facing generic competition.

A string of study failures over the past years, including the semagacestat one, has called into question the leading Alzheimer’s discovery strategy being pursued by companies such as Lilly, Pfizer and Johnson & Johnson: the theory that amyloid, sticky wads of protein accumulating in the brain, are the driving force of the debilitating disease.

“My problem philosophically is that nobody knows how Alzheimer’s starts and progresses, therefore the chances of hitting on a drug are very slim,” Les Funtleyder, a portfolio manager and healthcare strategist at Miller Tabak & Co. in New York, said in e-mailed comments. He has no estimate for Lilly’s solanezumab as he doesn’t think the treatment will be approved.

 

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. I still don't understand how the FBI had any right whatsoever to investigate this elderly collector. Before the Antiquities Act it was completely legal to buy, trade or collect Native American artifacts. I used to see arrow heads, axes, bowls, corn grinders at antique shops and flea markets for sale and I bought them myself. But that was in the late 60's and early 70's. And I now know that people used to steal items from sites and sell them. I understand that is illegal. But we used to find arrow heads and even a corn grinder in our back yard when I was a child. And I still have those items today in my small collection.

  2. I lived in California and they had many of the things noted in the proposed suggestions from the "Blue Ribbon Panel". California is near financial collapse now. Let's not turn the great state of Indiana into a third world dump like California.

  3. The temporary closure of BR Avenue will get a lot of attention. But, one thing reported by the IndyStar really stands out to me, and is extraordinarily depressing: “Police also have agreed to crack down on noise violations, traffic violations and public intoxication.” In other words, the police have generously agreed to do their jobs (temporarily, at least), instead of just standing around waiting for someone to call 911. When is someone in this department going to get off their fat arse (looking at you, Chief), get their minds out of 1975-era policing and into 2014, and have his department engage in pro-active work instead of sitting around waiting for someone to be shot? Why in the hell does it take 7 people getting shot in one night in one of the city’s biggest tourist destinations, to convince the police (reluctantly, it would appear) that they actually need to do their f’n jobs? When is the Chief going to realize that there’s a huge, direct, proven correlation between enforcing the law (yes, all laws, especially those affecting quality of life) and preventing larger crimes from occurring? Is it racial BS? Is that what this extraordinary reluctance is all about? Is the department and the city terrified that if they do their jobs, they might offend someone? Whom, exactly? Will the victims of violence, murder, assault, rape, robbery, and theft be offended? Will the citizens who have to tolerate their deteriorating quality of life be offended? Will the businesses who see their customers flee be offended? Or, is it simple ignorance (maybe the Chief hasn’t heard about NYC’s success in fighting crime - it’s only the biggest g*&#am city in the country, after all)? Either way, Chief, if you don’t want to do your job, then step down. Let someone who actually wants the job take it.

  4. I thought Indiana had all the funding it needed for everything. That's why the state lottery and casino gambling were allowed, as the new tax revenue would take care of everything the state wanted to do.The recommendations sound like they came from California. Better think about that. What is the financial condition of that state?

  5. I was a fan of WIBC in the morning, Steve was the only WIBC host that I listened too, he gave the news with so much flare that I enjoyed listening to him on my way to work. Katz is no Steve. Sadly, I will not be listening to WIBC anymore.

ADVERTISEMENT