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Insufficient efficacy to proceed with Lundbeck’s Tourette Syndrome study

Johan Luthman

Lundbeck has announced clinical results of a phase IIa investigational study with Lu AG06466 for the treatment of adult patients with Tourette Syndrome (TS).

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.

Investigational studies in other indications in neurology and psychiatry

“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,” says Johan Luthman, EVP and Head of R&D in Lundbeck.

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.

Photo of Johan Luthman: Lundbeck