Evotec's: Roche's Update Shows Alzheimer's Drug Fails In Phase IIb Trial

(RTTNews) - Evotec AG on Tuesday said it was updated by its partner Roche (RHHBY) on the initial results of the Phase IIb trial with Sembragiline (RG1577, EVT302), a MAO-B inhibitor for the treatment of Alzheimer's disease ("AD").

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, Evotec said.

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.

Evotec said the announcement has no impact on its financial guidance. In 2015, total Group revenues excluding milestones, upfronts and licences are expected to increase more than 35%.

Sembragiline 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 million. Roche is responsible for all costs, clinical development, manufacturing and commercialisation activities.