Lilly Announces Inconclusive Phase II Study Results for mGlu2/3 at the International Congress on Schizophrenia Research
Eli Lilly and Company logo. (PRNewsFoto)
INDIANAPOLIS, IN UNITED STATES
Development of the molecule continues following a positive proof-of-concept study published in the 2007 journal Nature Medicine
SAN DIEGO, March 29 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE:
LLY) announced today inconclusive Phase II clinical trial results from Study
HBBI investigating LY2140023 monohydrate, also known as mGlu2/3, for the
treatment of patients suffering from acute schizophrenia. In Study HBBI,
neither LY2140023 monohydrate, nor the comparator molecule olanzapine, known
to be more effective than placebo, separated from placebo. In this particular
study, Lilly observed a greater-than-expected placebo response, which was
approximately double that historically seen in schizophrenia clinical trials.
Because inconclusive clinical trial results are common in the field of
neuroscience and given the previous positive proof-of-concept study for this
compound, Study HBBD, which was published in the September 2007 issue of the
journal Nature Medicine, Lilly is continuing with the development of LY2140023
monohydrate. Lilly plans an additional Phase II study, Study HBBM, which if
positive, would validate the HBBD proof-of-concept trial results.
Six hundred sixty nine patients enrolled in Study HBBI and 393 completed
this four-week, in-patient trial. 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. LY2140023 monohydrate was generally well-
tolerated, although convulsions were observed in three patients. Furthermore,
LY2140023 monohydrate had a low association with adverse events commonly
associated with currently available antipsychotics and showed no appreciable
weight gain.
Steven Paul, M.D., executive vice president, science and technology, and
president, Lilly Research Laboratories, said, "All currently prescribed
antipsychotics act on dopamine receptors. Lilly remains optimistic that the
novel mechanism of compounds with the ability to reduce glutamate
hyperactivity, such as our mGlu2/3 receptor agonist, will someday represent
the next generation of breakthrough treatments for schizophrenia."
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs. Additional
information about Lilly is available at www.lilly.com.
C-LLY
This press release contains forward-looking statements about the potential
of LY2140023 monohydrate for the treatment of schizophrenia, and reflects
Lilly's current beliefs. However, as with any pharmaceutical product, there
are substantial risks and uncertainties in the process of development and
commercialization. There is no guarantee that the compound will receive
regulatory approval, or that it be commercially successful. For further
discussion of these and other risks and uncertainties, see Lilly's filings
with the United States Securities and Exchange Commission. Lilly undertakes no
duty to update forward-looking statements.
