MorphoSys AG announced that the first patient has been enrolled in a new phase 3 trial of gantenerumab in patients with early Alzheimer's disease. Gantenerumab is a monoclonal antibody directed against amyloid-beta generated by MorphoSys using its proprietary HuCAL antibody technology. Roche is fully responsible for the clinical development of gantenerumab. MorphoSys is entitled to receive potential success-based regulatory milestone payments related to gantenerumab and royalties on net sales.

Expected to enroll approximately 1,520 patients in up to 350 study centers in 31 countries worldwide, the pivotal program consists of the two phase 3 studies named GRADUATE-1 and GRADUATE-2. The two multicenter, randomized, double-blind, placebo-controlled trials will enroll up to 760 patients each, to assess the efficacy and safety of gantenerumab in patients with early (prodromal to mild) Alzheimer's disease. All participants need to show evidence of beta-amyloid pathology. Patients will receive placebo or gantenerumab as subcutaneous injection with optimized titration up to the target dose. The primary endpoint for both trials is the assessment of signs and symptoms of dementia, measured as the clinical dementia rating-sum of boxes (CDR-SOB) score, determined as the change of the status from baseline to week 104.

"This is great news for MorphoSys. We are delighted by the commitment to gantenerumab as a potential new therapy for Alzheimer's disease, and the sustained clinical development of this antibody in this area of immense unmet medical need. We look forward to seeing the effect of the optimized dosing regimen in the new phase 3 trials run by our partner Roche in early Alzheimer's patients," commented Dr. Markus Enzelberger, chief scientific officer of MorphoSys AG.

MorphoSys is a late-stage, biopharmaceutical company devoted to the development of innovative and differentiated therapies for patients suffering from serious diseases. Based on its technological leadership in generating antibodies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 28 are currently in clinical development.