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news.MorphoSys has reached a milestone in collaboration with Roche due to expansion of ongoing SCarlet RoAD Phase 2 trial of gantenerumab for prodromal (early) Alzheimer's disease to a potentially pivotal study.
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Roche will increase the trial size from 360 to 770 participants, and a favorable outcome to the trial could be used by Roche to support a marketing application for gantenerumab.
MorphoSys is positioned to receive further developmental milestones as well as royalties on product sales.
MorphoSys chief scientific officer Marlies Sproll said Gantenerumab is the first investigational antibody development program for Alzheimer’s disease to be clinically tested in a setting for which there is great hope, namely the treatment of early-stage, pre-dementia subjects.
"A potential path to market for this program has become much clearer with this transition to a pivotal trial," Sproll added.
Gantenerumab is a fully human antibody that was developed on behalf of Roche by MorphoSys using the proprietary HuCAL technology.
The ongoing trial is designed to evaluate Gantenerumab’s effect on cognition and functioning as well as its safety and pharmacokinetics in patients with prodromal, or early-stage, Alzheimer’s disease.
Roche Neuroscience head Luca Santarelli said, "Our attempt is to utilize a biomarker-driven approach, leveraging both our pharmaceutical and diagnostics divisions to develop a companion diagnostic for gantenerumab to select patients at the prodromal stage, before significant damage to the brain has occurred."