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Lilly’s schizophrenia drug fails in late-stage study

Blow for pomaglumetad methionil development as antipsychotic with fewer adverse effects

Eli Lilly's pomaglumetad methionil has failed to reach its primary endpoint in a clinical study investigating the drug's use in schizophrenia.

The US-based pharma firm had been researching the drug's use in the treatment of patients suffering an acute exacerbation of schizophrenia, however a phase III trial was unable to demonstrate either of the doses studied were any better than placebo based on patients' results in the positive and negative syndrome scale (PANSS).

Even more disappointing for Lilly was that the active control, Janssen's Risperdal (risperidone), did demonstrate superiority to placebo in the subpopulations involved.

"Unfortunately negative studies are common in the field of psychiatry and a reality of biopharmaceutical innovation," said Dr Jan Lundberg, executive VP, science and technology, and president, Lilly Research Laboratories.

The drug is an agonist of the metabotropic glutamate receptor types 2 (mGluR2) and 3 (mGluR3) – a novel method of action that is thought to cause fewer adverse events, such as weight gain, than other antipsychotics due to a lack of interaction with central nervous system receptors.

However, the latest announcement comes as a blow to Lilly's hopes of submitting pomaglumetad methionil for regulatory approval, despite the drug still being involved an additional phase III trial.

Lilly said it will conduct an interim analysis of this second study analysing the drug as a monotherapy in acute schizophrenia, and will provide results later in the year.

In addition, Lilly is also waiting on the results of the recently concluded phase II study H8Y-MC-HBCO (HBCO), which is investigating 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,” said the company.

13th July 2012

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