While there was insufficient efficacy to proceed with development of Lu AG06466 in Tourette Syndrome, the safety and tolerability of the agent was such that further investigational studies in additional indications will proceed.
H. Lundbeck A/S (Lundbeck) today announced clinical results of a phase IIa investigational study with Lu AG06466 for the treatment of adult patients with Tourette Syndrome (TS). TS is a neuropsychiatric disorder characterized by sudden, involuntary, and repetitive motor and vocal tics often preceded by uncomfortable premonitory sensations (urges).
The randomized, double blind, placebo controlled and with individual dose titration clinical trial enrolled 48 patients at multiple sites in Europe. In this study the primary endpoint, Yale Global Tic Severity Scale (YGTSS-TTS) was not statistically significant in favoring Lu AG06466 compared to placebo after 28 and 56 days of treatment. The study did not show any adverse events that prohibit development in other indications. The most common (≥ 10%) adverse events reported in Lu AG06466 treatment group more frequently than in placebo were fatigue, disturbance in attention, nasopharyngitis and paresthesia. The type of adverse events was in line with what has been observed in previous studies
Dr. Johan Luthman, EVP and Head of R&D in Lundbeck said:
“This is the first study in a novel biology and so while we hoped it would yield a positive result, I think it is important to note that further exploration both of this molecule and the endocannabinoid biology will continue. The research ongoing at Lundbeck La Jolla Research Center, gives Lundbeck the opportunity to develop multiple new classes of drugs for a broad spectrum of brain diseases and harnessing the therapeutic potential of one of the largest and most diverse enzyme classes – the serine hydrolases”.
Lundbeck is planning investigational studies in other indications in neurology and psychiatry both with Lu AG06466 and with additional compounds generated by Lundbeck La Jolla Research Center.
About Lu AG06466 (former ABX-1431)
Lu AG06466 is an inhibitor of the monoacylglycerol lipase (MAGL) and selective modulator of the endocannabinoid system, and thereby works to reduce excessive neurotransmission and neuroinflammation that are known pathophysiological hallmarks for a range of psychiatric and neurological disorders.
|Mikkel Ballegaard Pedersen||Mads Kronborg|
|Journalist, Corp. Communication||Senior Director, Corp. Communication|
|+45 30 83 20 44||+45 36 43 40 00|
|Palle Holm Olesen|
|+45 30 83 24 26|
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.
An estimated 700 million people worldwide are living 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.
Read more at www.lundbeck.com/global/about-us/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 centres in Denmark and the US and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 17.0 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).
H. Lundbeck A/S
Ottiliavej 9, 2500 Valby, Denmark
+45 3630 1311