Lundbeck Discontinues Phase II Schizophrenia Study Following Interim Analysis

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Denmark-based Lundbeck discontinued a mid-stage proof of concept study of a schizophrenia drug following an interim analysis of data that indicated the study will not achieve statistical significance in its primary endpoint.

Lundbeck announced this morning it will halt the Phase II study of its experimental asset Lu AF11167, a selective inhibitor of the phosphodiesterase 10A enzyme (PDE10Ai), which modulates dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors. The asset was being studied as a potential treatment of patients with schizophrenia, who are experiencing persistent negative symptoms. PDE10Ai is believed to reduce negative symptoms and to keep positive symptoms stabilized. There are no approved treatments for this particular indication, Lundbeck said.

Lundbeck halted the trial following 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). Lundbeck said there were no safety issues involved with the decision to terminate the trial. Results of the halted study will be published at a future date, the company said.

“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. We are very grateful for the patients and the clinical study sites that participated in this proof of concept study. 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,” Johan Luthman, Lundbeck’s head of R&D said in a statement.

The primary objective of the phase II study was to evaluate the efficacy on negative symptoms of two doses of Lu AF11167 versus placebo as monotherapy in patients with schizophrenia and persistent prominent negative symptoms. The secondary objective was to evaluate the efficacy of Lu AF11167 on patients’ functioning as well as the safety and tolerability of the compound.

In 2018, Lundbeck saw another disappointing clinical result in schizophrenia. A Phase III assessment of Lu AF35700 failed to differentiate itself against conventional schizophrenia therapies.

It is estimated that more than 21 million people across the globe suffer from schizophrenia, a mental illness caused by an imbalance in the neurotransmitters facilitating the communication between neurons in the brain. That imbalance causes schizophrenia patients to perceive things that are not real. People with schizophrenia experience disturbed thoughts, emotions and behavior, and they find it difficult to judge reality. Negative symptoms, a diminution or absence of normal behaviors related to motivation and interest or expression, are a core component of schizophrenia and they account for a large part of the long-term morbidity and poor functional outcome in patients with the disorder.

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