Lundbeck announces the decision to discontinue the phase II proof of concept clinical study of Lu AF11167 in patients with schizophrenia, who are experiencing persistent negative symptoms.
The decision to stop the trial is based on the results of a futility interim analysis, which concluded that the trial is unlikely to achieve statistical significance on its primary endpoint, mean change from baseline to week 12 on the Brief Negative Symptom Scale (BNSS). The recommendation to stop the trial is not based on safety concerns.
A huge unmet medical need
“The outcome from this interim analysis helps us to prioritize Lundbeck’s resources towards opportunities that have the highest promise for our patients.”
“Negative symptoms are a symptomatology of schizophrenia, for which there is no approved medical treatment today. It is disappointing that Lu AF11167 did not show the efficacy needed to treat this area which impacts many patients and represents a huge unmet medical need. The outcome from this interim analysis helps us to prioritize Lundbeck’s resources towards opportunities that have the highest promise for our patients. We will now close the study in a responsible manner and ensure that valuable knowledge gathered is made accessible to researchers globally,” says Johan Luthman, Executive Vice President, R&D at Lundbeck.
Photo of Johan Luthman: Lundbeck