Lundbeck announces double trial failures

March 30, 2020

Denmark's H. Lundbeck announced two separate failed mid-stage studies, one in Parkinson's and another in Tourette syndrome.

The Phase 2a AMBLED trial tested Lundbeck's novel selective positive allosteric modulator of the glutamate 4 receptor, foliglurax, for the treatment of Parkinson's disease. The randomized, double-blind placebo-controlled study involved 157 subjects diagnosed with idiopathic Parkinson’s disease for at least three years, being treated with a stable regimen of levodopa-based therapy and experiencing OFF time and dyskinesia. There was no statistically significant difference in change from baseline in OFF time versus placebo after a 4-week treatment period. The brain disease specialist has now stopped development of the glutamate 4 receptor modulator.

The second trial — a Phase 2a study evaluating Lu AG06466 in adults with Tourette syndrome — was a randomized, double blind, placebo controlled clinical trial enrolling 48 patients at multiple sites in Europe. In this study the primary endpoint, Yale Global Tic Severity Scale, was not statistically significant in favoring Lu AG06466 compared to placebo after 28 and 56 days of treatment. Lundbeck is planning investigational studies in other indications in neurology and psychiatry both with Lu AG06466 and with additional compounds.