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Roche restarts pivotal Gantenerumab tests

Aβ deposits in the brain, @ fotolia/RF Science


by tg

MorphoSys AG has announced that its partner Roche plans to start two further pivotal Phase III studies with its licensed Alzheimer’s antibody Gantenerumab. 

After a failed Phase III trial in Q4/15, it looked like Amyloid-beta (Aβ) targeting Gantenerumab would disappear from pipelines like all other Alzheimer’s drug candidates that targeted Aβ so far. Focused on how to increase the dose of the antibody in early-onset Alzeimer’s patients without triggering safety signals, Roche will now initiate a new pivotal programme for a higher dose of gantenerumab in 750 patients with prodromal to mild Alzheimer’s disease. However, failures of Aβ targeting drug candidates have cast doubt on the whole approach.

According to MorphoSys, enrolment will be started later this year. Roche did not publish further details of the trials. “This is great news for MorphoSys. We are delighted by the strong commitment to gantenerumab as a potential new therapy for Alzheimer's disease,” commented Marlies Sproll, Chief Scientific Officer of MorphoSys AG.

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