Valby, Denmark, 5 August 2020 - 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.
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.
Safe Harbor/Forward-Looking Statements
The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance.
Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.
Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made considering past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.
[i] American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 5th edition (DSM-5). Washington, D.C.: American Psychiatric Association; 2013.
[ii] World Health Organization. Schizophrenia fact sheet, 2016. Available at http://www.who.int/mediacentre/factsheets/fs397/en/. Accessed May 2018.
[iii] Tsuang MT, Farone SV. Schizophrenia. Second edition. Oxford University Press Inc., New York: 2005.
[iv] Ochoa S, Usall J, Cobo J, Labad X, Kulkarni J. Gender differences in schizophrenia and first-episode psychosis: a comprehensive literature review. Schizophr Res Treatment. 2012;2012:916198.
H. Lundbeck A/S
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