SCarletRoAD Trial of Gantenerumab in Prodromal Alzheimer’s Discontinued

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by Isaura Santos |

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German biotechnology company, MorphoSys, was informed by its partner, Swiss global health-care company, Roche, about their decision to discontinue gantenerumab‘s Phase III SCarletRoAD trial for prodromal Alzheimer’s Disease patients. This decision is supported by a recommendation from the Independent Data Monitoring Committee, and by a pre-planned futility assessment. According to Roche, the trial was a lacking sufficient safety parameters. The Phase III trial of gantenerumab, Marguerite RoAD, for patients with mild Alzheimer’s Disease, however, will still push through.

The Chief Scientific Officer of MorphoSys, Dr. Marlies Sproll, commented in a press release: “The discontinuation of the SCarletRoAD study is regrettable. Nevertheless, two trials in patients with mild Alzheimer’s Disease and in genetically pre-disposed individuals are continuing. MorphoSys has a very broad clinical pipeline including three programs in pivotal studies and ten in phase 2 trials. Due to the breadth of our pipeline we are not dependent on the outcome of individual trials and compounds in development.”

MorphoSys, thanks to its expertise, resources and strategic partnerships, has an impressive list of antibody drug candidates, designed to treat Alzheimer’s disease, rheumatoid arthritis, cancer and many other health conditions with unmet medical needs. Twenty-one of the Company’s antibodies are currently being evaluated in more than 60 clinical trials. The company is currently operating 94 research programs, comprised of collaborations and MorphoSys’ own initiatives. Gantenerumab is a fully human antibody that works to target amyloid-beta – a hallmark of Alzheimer’s disease. The SCarletRoAD trial, now discontinued, was able to enroll 799 patients.

Besides the Marguerite RoAD trial, which is proceeding with evaluating 1,000 patients with a mild form of the disease, another trial conducted by the Dominantly Inherited Alzheimer Network (DIAN) will evaluate “the safety, tolerability and biomarker efficacy of the drug in individuals who have a genetic predisposition for Alzheimer’s disease.”

Recent Updates On Alzheimer’s

Recent news on treatments for Alzheimer’s disease include an announcement from Actavis and Adamas Pharmaceuticals Inc., saying the US Food and Drug Administration has accepted Namzaric‘s New Drug Application (NDA) as a fixed-dose combination of memantine hydrochloride extended-release and donepezil hydrochloride for the treatment of moderate to severe Alzheimer’s Disease.