Eli Lilly reported at the International Congress on Schizophrenia Research that Phase II study results of its experimental schizophrenia treatment LY2140023 were “inconclusive,” due to a greater-than-expected response in patients taking placebo. The company said it plans to undertake an additional mid-stage study on the compound next year, and it explained that the decision to continue development is based in part on previously announced data for the drug.

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The most recent trial enrolled 669 patients with acute schizophrenia, 393 of whom completed the four-week study. A primary analysis showed that none of the four doses of LY2140023 administered twice daily “separated from placebo.” In addition, Eli Lilly noted that for patients who took the comparator drug Zyprexa (olanzapine) once daily, Zyprexa did not separate from placebo. The drugmaker said the higher-than-expected placebo response was approximately double what has typically been observed in schizophrenia clinical trials.

Regarding side effects, findings showed that LY2140023 had a “low association” with adverse events commonly linked with current antipsychotic treatments, and that patients taking LY2140023 showed no appreciable weight gain. However, Eli Lilly also indicated that convulsions were observed in three patients taking its experimental mGlu2/3 receptor agonist.

Commenting on the news, Steven Paul, president of Lilly Research Laboratories, stated that the company “remains optimistic that the novel mechanism of compounds with the ability to reduce glutamate hyperactivity…will someday represent the next generation of breakthrough treatments for schizophrenia.” However, Leerink Swann analyst Seamus Fernandez described the data as a “serious blow” to Eli Lilly’s pipeline, saying that “any additional studies [with LY2140023] should be viewed as exploring the mGlu2/3 mechanism, but the agent should not move forward into Phase III studies due to safety concerns.”

Source: FirstWord

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