Lilly is pushing on with clinical development of its schizophrenia therapy candidate pomaglumetad methionil (mGlu2/3) despite disappointing results from the first of Phase III registrational trials. The H8Y-MC-HBBM study evaluated mGlu2/3 therapy in patients suffering an acute exacerbation of schizophrenia, but found the drug to be no better than placebo in terms of improvements measured using the Positive and Negative Syndrome Scale (PANSS), either in the overall or predefined genetic subpopulations.
A second pivotal study testing mGlu2/3 as monotherapy in acute schizophrenia is ongoing. Lilly says it will carry out an interim analysis of the trial, designated H8Y-MC-HBBN, which will generate results later this year. Data from a recently conducted Phase II trial evaluating mGlu2/3 as an adjunct to treatment with atypical antipsychotics are also awaited. Data from all the studies will be used to make decisions on future development of the drug. Meanwhile, ongoing clinical trials will continue.
Pomaglumetad methionil is a glubamatergic-based drug that is designed not to interact with central nervous system receptors believed to be responsible for many of the adverse effects associated with current schizophrenia treatments. “Unfortunately, negative studies are common in the field of psychiatry,” comments Jan Lundberg, Ph.D., executive vp for science and technology, and president of Lilly Research Laboratories.
“Lilly has long been a pioneer in neuroscience, and we’re committed to discovering and delivering breakthrough treatments that make a difference for patients. Right now, we’re developing more than a half dozen potential new medicines to treat neuroscience-related diseases and disorders including, among others, depression, Alzheimer disease, and schizophrenia.”