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Lilly pomaglumetad methionil study falls short of primary endpoint

Thursday, July 12, 2012

Eli Lilly reported negative clinical trial results from study H8Y-MC-HBBM (HBBM) investigating pomaglumetad methionil, also known as mGlu2/3, for the treatment of acute exacerbation of schizophrenia.

In study HBBM, pomaglumetad methionil did not separate from placebo in the primary efficacy endpoint in either the overall or predefined genetic subpopulation (based on the Positive and Negative Syndrome Scale, PANSS) at the two doses investigated (40mg and 80mg BID). The active control, risperidone, did separate from placebo in both populations. Pomaglumetad methionil was generally well tolerated in this study, with no new safety findings compared to previous trials.

HBBM was intended to be the first of two clinical trials to support registration of the compound for monotherapy in acute schizophrenia. The second registration clinical trial, H8Y-MC-HBBN (HBBN), is ongoing. Eli Lilly will conduct an interim analysis of study HBBN, which will provide results later in the year. Additionally, the company awaits results from the recently concluded study H8Y-MC-HBCO (HBCO), a phase II study exploring pomaglumetad methionil as an adjunctive treatment with atypical antipsychotics. Data from these two studies will help inform decisions on the future development of pomaglumetad methionil. Ongoing clinical trials with pomaglumetad methionil continue.

“Unfortunately negative studies are common in the field of psychiatry and a reality of biopharmaceutical innovation,” said Jan Lundberg, Ph.D., president and executive vice president or science and technology, Lilly Research Laboratories. “Despite all of the advances, the need for new and better treatments for those suffering with mental illnesses is among the most urgent in medicine.

Data from the HBBM study will be shared at a later date.

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