Pomaglumetad methionil: Development discontinued

Eli Lilly discontinued development of pomaglumetad methionil after a futility analysis showed that the double-blind, international Phase III H8Y-MC-HBBN trial of the compound was "unlikely to be positive" on the primary endpoint of improving PANSS total score from baseline vs. placebo if enrolled to completion. Lilly said the decision was not based on any safety signals. The trial was designed to enroll about 1,100 patients with schizophrenia to receive placebo or twice-daily 10, 40 or 80 mg oral pomaglumetad methionil as monotherapy for up to 7 weeks. Lilly also reported that the double-blind, international Phase II H8Y-MC-HBCO trial in about 280 patients with prominent negative symptoms of schizophrenia showed that twice-daily oral pomaglumetad methionil as an adjunct to atypical antipsychotics missed the primary endpoint of improving NSA-16 scores from baseline vs. placebo. Lilly said it expects to incur a $25-$30 million charge, or about $0.02 per share, in R&D expenses this quarter as a result of the discontinuation. ...