Eli Lilly and Company has decided to stop ongoing clinical studies investigating pomaglumetad methionil, also known as mGlu2/3, for the treatment of patients suffering from schizophrenia. The decision was made after a recently conducted independent futility analysis concluded HBBN, the second of Lilly's two pivotal studies, was unlikely to be positive in its primary efficacy endpoint if enrolled to completion. The decision was not based on any safety signals.
Additionally, the recently completed phase II study, HBCO, which investigated pomaglumetad methionil as an adjunctive treatment with atypical antipsychotics, did not meet its primary endpoint.
Lilly is contacting study investigators to outline specific actions related to the close-out of each ongoing study. Lilly will work with study investigators to ensure an appropriate transition of study participants to continuing clinical care outside of the trials.
"I'm disappointed in what these results mean for patients with schizophrenia who still are searching for options to treat this terrible illness," said Jan Lundberg, executive vice president, science and technology, and president, Lilly Research Laboratories. "While there are many challenges in this complex field of research, neuroscience remains a core area of focus at Lilly. Our clinical development pipeline includes nearly a dozen neuroscience molecules being studied to treat illnesses such as depression, bipolar disorder and cognitive impairment associated with schizophrenia."
The decision to stop ongoing Phase III development of pomaglumetad methionil is expected to result in a third-quarter charge to R&D expense in the range of $25 million to $30 million (pre-tax), or approximately $0.02 per share (after-tax). The company's previously-issued financial guidance for 2012 remains unchanged.