Furious Seasons

March 30, 2009

Lilly's Experimental Schizophrenia Drug Fails Major Trial

Over the weekend, news came out that Eli Lilly's compound LY2140023, also known as mGlu2/3, failed to outperform placebo in a major phase 2 clinical trial, marking a major setback for the drug.

That's discouraging news for Lilly, as the drug had shown some promise in an earlier trial of about 200 patients and had gotten a ton of press attention as being a new way to address psychosis without larding the pounds onto patients. The drug works on glutamate receptors instead of the usual antipsychotic target of dopamine receptors.

"In the latest trial, however, the results fell short of the mark. Lilly tested the drug on 393 patients for four weeks. The drug failed to outperform Zyprexa. More surprisingly, Lilly said the drug did not outperform a placebo. The response of patients to the placebo was approximately double that normally seen in schizophrenia clinical trials."

It's interesting that there was such a large placebo response in the trial, especially since placebo response in trials involving patients with psychosis generally runs around a 10 percent to 20 percent response rate (at least in trials I'm familiar with).

It's also interesting that placebo performed roughly as well as Zyprexa.

In a press release, the company noted:

"A higher-than-expected placebo response was observed (14.6 points improvement) as measured by the Positive and Negative Syndrome Scale (PANSS) total score. The primary analyses did not demonstrate that any of the four LY2140023 monohydrate doses (5, 20, 40 and 80 mg taken twice daily) separated from placebo. Similarly, olanzapine at 15mg once daily also did not separate from placebo."

Lilly plans more clinical trials of LY2140023.

Posted by Philip Dawdy at March 30, 2009 12:05 AM

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Comments

Dear Shareholders,

Don't panic. We will find a way to approve the drug in the next clinical trial. FDA is on our $ide.
Eli-Lilly

Posted by: Ana at March 30, 2009 02:50 AM

I think they need to fine tune the drug focusing on the glutamate receptors and consider all brains and bodies react differently. I also think comparing it to Zyprexa is what their problem is, but then Zyprexa is a problem drug already.

Posted by: Stephany at March 30, 2009 08:32 AM

About that big placebo effect: Maybe the subjects were told they were testing a new drug for schizophrenia symptoms that was NOT an atypical antipsychotic. Given the hell people have been through on the atypicals... that would have set off such a tidal wave of hope that EVERYONE in the study group would have started feeling better!

Posted by: Johanna at March 30, 2009 11:38 AM

http://www.alternativementalhealth.com/articles/causesofschizophrenia.htm
There are 29 known causes of schizophrenia. Correcting them can cure patients.

Posted by: Lilly NC at March 30, 2009 04:21 PM

Hurry, Lilly. Your Zyp. patent is running out in 2011.

If this latest fails, just add a couple of molecules to Zyp., change the name and color of the capsule, go to the FDA and you're in business: Remember, that's what you did with Prozac!

Posted by: Anon. at March 30, 2009 06:30 PM

Hey Stephany:
You think the problem was comparing the new drug to Zyprexa??? How about the fact that the new drug didn't outperform placebo? Isn't THAT the REAL problem???

Posted by: Tom at March 30, 2009 07:47 PM

Tom, calm down, I was ripping Zyprexa. Lilly is up against Merck on this glutamate SZ drug. ZYprexa should be off the market, so should Seroquel, want to talk real problems? All of these drugs kill people, or ruin them for life. Isn't THAT the real problem???

Posted by: Stephany at March 30, 2009 11:00 PM

Oh I think it's Wyeth.

Posted by: Stephany at March 31, 2009 09:38 AM

http://www.alternativementalhealth.com/articles/causesofschizophrenia.htm There are 29 known causes of schizophrenia. Correcting them can cure patients.

According to the author of this site, "The term 'schizophrenia' is an inadequate and misleading diagnosis. 'Disperceptions of unknown cause' is a better term."

He then goes on to list his 29 "causes of schizophrenia," which he just described as "disperceptions of unknown cause." So how is it that he knows the cause of these "disperceptions" since by his own definition they're of "unknown cause"?

We don't know the cause of schizophrenia. We do know that many conditions and substances can induce psychosis, but psychosis doesn't automatically equate with schizophrenia. And Pfeiffer doesn't (didn't, actually -- he's been dead for more than 20 years) get to change the definition to better suit his argument.

Interesting Pfeiffer trivia, from his obituary in The New York Times: "In 1977, it was revealed that Dr. Pfeiffer was one of several researchers who had performed experiments in behavior control for the Central Intelligence Agency. Between 1955 and 1964, he administered the drug LSD to prisoners in Atlanta and Bordentown, N.J., under a program financed indirectly by the C.I.A. "

Posted by: lkhllywd at March 31, 2009 02:42 PM

About lillys " failed trial" with LY2140023-- they plan to continue because of success in previous trials. It is very common to have an inconclusive test. Also, how strange placebo out performed Zyprexa- it is the best at targeting positive symptons. But the s/e are killers. " FURIOUS SEASONS" is the place to go to gloat/whine over drugs that could help the M.I. Just wonder, are any of you really sick?

Posted by: LUCIE at April 2, 2009 12:32 PM

The CIA is a well-known infiltrator - and drug supplier.
History shows that 20thC studies in mental health were observed and covertly controlled or openly funded by the CIA - who were interested in mind control, not mental health.
http://www.serendipity.li/cia.html#mind_control
Scientists who studied schizophrenia - Walsh, Hoffer, Osmond, and others - were interested in LSD for what it could reveal about malvaria/pyroluria, a form of porphyria. Pyroluria is one of the major causes of schizophrenia, and is easily corrected with vitamins and trace elements. Porphyria ("the madness of King George III" ) is accepted in mainstream medicine - and pyroluria is not, though it is the same chemistry differently arranged.
http://server03.cpa-apc.org:8080/Publications/archives/CJP/2005/June/InRevDyck.asp
Nutrition for mental health harms and kills no one, and can restore function and prolong life. Psychiatric drugs merely control symptoms at best, DO harm and DO kill.

Posted by: Lilly NC at April 14, 2009 09:34 AM