Lundbeck discontinues phase II proof of concept study of Lu AF11167 in patients with negative symptoms of schizophrenia

H. Lundbeck A/S (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 (NCT03793712). 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.

Lundbeck is incredibly grateful to all the patients with schizophrenia, their families and the investigators who participated in the trials and contributed greatly to this research.

Dr. Johan Luthman, Executive Vice President, R&D at Lundbeck said:

“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. 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.”

The study results are planned to be submitted for scientific publication at a later date.

About the study

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. This 3-arm study was planned to randomize a total of 240 patients (80 patients per arm) from various European countries.

About Lu AF11167

Lu AF11167 is a small molecule and a potent and selective inhibitor of the phosphodiesterase 10A enzyme (PDE10Ai). PDE10Ai modulates dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors. PDE10Ai is believed to reduce negative symptoms and to keep positive symptoms stabilized.

About schizophrenia

Schizophrenia is caused by an imbalance in the neurotransmitters facilitating the communication between neurons in the brain, leading to the perception (seeing/hearing/thinking) of things that are not real. The factors that create this imbalance are not fully understood. Schizophrenia is a common form of severe mental illness that carries a notable ‘stigma’ and is often misunderstood. People with schizophrenia experience disturbed thoughts, emotions and behavior, and they find it difficult to judge reality^[i]. This can have a major impact on the life of the individual and his/her family. 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.

The World Health Organization estimates that over 21 million people suffer from schizophrenia, making it one of the top 20 causes of disability worldwide^[ii]. Schizophrenia affects people regardless of race, culture or social class. It typically starts in early adulthood (from age 20)^[iii], but it can develop at any age. Schizophrenia affects both men and women, although men tend to develop the condition slightly earlier in life^[iv]. The risk of an individual developing schizophrenia during his or her lifetime is approximately 1 percent.

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About H. Lundbeck A/S

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the U.S., and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.