Proof-of-concept studies with EVT 302 are projected to start in 2012.
Roche is paying Evotec $10 million up front as part of a deal to develop the latter’s MAO-B inhibitor, EVT 302, for the treatment of Alzheimer disease (AD). Under terms of the deal Roche will be responsible for all clinical development, manufacturing, and commercialization activities, and aims to initiate proof-of-concept studies in 2012. Evotec could earn up to $820 million in development and commercial milestones from Roche, plus tiered double-digit sales royalties. EVT 302 was originally licensed to Evotec by Roche back in 2006, and initially developed for a different indication, Evotec notes.
EVT 302 is a selective MAO-B inhibitor, which Evotec believes has potential as a disease-modifying therapy in Alzheimer-slowing disease progression. The firm has completed a trial with eight-week dosing of EVT 302, which it says demonstrated an excellent safety and tolerability profile at doses that resulted in complete inhibition of the MAO-B enzyme. Clinical evaluation has in addition shown that EVT 302 has no interaction with tyramine at doses at least two-fold higher than those producing complete MAO-B inhibition.
“The addition of EVT-302 to our CNS pipeline complements other approaches we are investigating including tau- and amyloid-targeted therapies,” comments Jean-Jacques Garaud, head of Roche Pharma research and early development. The firm’s existing clinical AD pipeline includes two Phase II-stage drugs: the Morphosys-partnered HuCAL-derived monoclonal antibody RG1450 (gantenerumab), and an anti-Abeta monoclonal antibody, which is in development in partnership with Swiss AD therapeutics firm AC Immune. The anti-Abeta candidate has been developed using AC Immune’s SupraAntigen™ platform, and is being taken through clinical development by Roche’s Genentech. Phase II trials were initiated earlier this year.