Clinical Trials

Date: 2015-06-16

Type of information: Results

phase: 2a

Announcement: results

Company: Roche (Switzerland)

Product: sembragiline (RG1577, EVT302)

Action mechanism:

monoamine oxidase  type B inhibitor. Sembragiline (RG1577, EVT 302) is an inhibitor of monoamine oxidase type B (MAO-B), an enzyme that breaks down the chemical messenger dopamine in the brain and contributes to the production of free radicals. Free radicals are known to cause oxidative stress which may contribute to pathogenesis of AD as demonstrated by the up-regulation of MAO-B expression in the brain of AD patients. For these reasons, the selective MAO-B inhibitor is targeted to treat AD symptoms and potentially slow disease progression.Sembragiline  The compound was originally licensed from Roche to Evotec in 2006, and initially developed in another indication. In 2011, Evotec and Roche entered into an exclusive worldwide agreement for the development and commercialization in patients with Alzheimer\'s disease. Under the terms of the agreement, Roche paid Evotec an upfront fee of $ 10 m. Roche is responsible for all costs, clinical development, manufacturing and commercialisation activities.


Disease: Alzheimer\'s disease

Therapeutic area: Neurodegenerative diseases


Trial details:

Latest news:

* On June 16, 2015, Evotec was updated by its partner Roche on the initial results of the Phase IIb trial with sembragiline (RG1577, EVT302), a MAO-B inhibitor for the treatment of Alzheimer\'s disease. In this study, sembragiline failed to demonstrate benefit on the primary endpoint (Alzheimer\'s Disease Assessment Scale - Cognitive Behaviour Subscale, ADAS-cog-11) after 52 weeks of treatment. Preliminary safety analyses showed that sembragiline was well tolerated with no safety signals identified. Roche has initiated a process to evaluate all secondary endpoint read-outs on sembragiline and to consider all further development options. The multicentre, randomised, double-blind, parallel-group, placebo-controlled Phase IIb study was undertaken to evaluate the efficacy and safety of Sembragiline in patients with moderate severity Alzheimer\'s disease added on background of AD standard therapy.

Is general: Yes