Valby, Denmark, 22 September 2016 - H. Lundbeck A/S (Lundbeck) today announced the headline conclusions from the first clinical phase III study, STARSHINE[i], in the ongoing phase III programme evaluating the efficacy of the investigational drug idalopirdine for the symptomatic treatment of patients with mild to moderate Alzheimer’s disease.
In the STARSHINE study, idalopirdine showed a weak efficacy profile as neither of the two dosages used in the study met the primary endpoint of a reduction in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score when added to donepezil. In addition, the secondary endpoints also did not show separation from placebo. The overall safety profile for idalopirdine showed that idalopirdine was safe and well tolerated. Further analysis of the data is ongoing.
“We are disappointed about the outcome of this study,” said Dr. Anders Gersel Pedersen, EVP and Chief Scientific Officer at Lundbeck. “The phase II data were very encouraging but unfortunately, these data failed to replicate those findings”.
The two remaining studies, STARBEAM and STARBRIGHT[ii], in the phase III programme that currently are ongoing will continue as planned and data are expected in the first quarter of 2017.
Idalopirdine is a selective 5-HT6 receptor antagonist. The 5-HT6 receptor is expressed in brain regions involved in cognition, such as the cortex and the hippocampus, and modulates activity of multiple neurotransmitter systems.
Through 5-HT6 receptors expressed on glutamatergic neurons and GABAergic interneurons, idalopirdine is believed to modulate the balance between excitation (glutamate) and inhibition (GABA) in the brain. When administered together with donepezil, idalopirdine potentiates the effects of the AChEI on ACh levels and on neuronal activity in the cortex and hippocampus.
Positive results of a 24-week clinical phase II trial with idalopirdine as adjunctive therapy in moderate Alzheimer's disease have been presented and to confirm the phase II findings, a large idalopirdine phase III program as adjunct to acetylcholinesterase inhibitors in mild-moderate AD patients is ongoing. The development program is part of the alliance with Otsuka Pharmaceuticals Co. Ltd.
|Palle Holm Olesen||Mads Kronborg|
|Vice President, Investor Relations||Senior Director, Corp. Communication|
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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 psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease.
An estimated 700 million people worldwide are living with psychiatric and neurological disorders 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 psychiatric and neurological disorders – we call this Progress in Mind.
Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, manufacturing, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have research centres in China and Denmark and production facilities in China, Denmark, France and Italy. Lundbeck generated core revenue of DKK 14.6 billion in 2015 (EUR 2 billion; USD 2.2 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck.
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 taking into account 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.
[ii] NCT02006641 and NCT02006654
Last updated on: 25/09/2016
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