Roche Advances Prasinezumab into Phase III Trial for Early Parkinson’s Disease Despite Mixed Phase II Results

On June 16, Roche announced that it had decided to continueLaunchPhase III Clinical Study of Prasinezumab。Prasinezumab is a research-stageAnti-α-Synuclein（α-Syn）Monoclonal Antibody`, for the treatment of`Early Parkinson's Disease。

This decision is based on data from the Phase IIb PADOVA study and the ongoing PADOVAOpen-Label Extension (OLE) Study, andPhase II PASADENA Study Data.

Source: Roche Official Website

Multiple endpoints from the PADOVA and OLE studies indicate that, in patients with early Parkinson's diseaseOn the basis of effective symptomatic treatment, usePrasinezumab TreatmentWith potential clinical benefits。Prasinezumab At the primary endpoint(i.e., the time to confirm the progress of the exercise)Showed potential clinical efficacy in China, despiteLack of statistical significance。

At 104 Weeks(Two years)At the same time, a positive trend of slowed disease progression was observed; based on additional OLE data, these effects appear to persist over longer treatment periods. The PADOVA study also providesprasinezumab The First Bio Affecting the Biology of Potential DiseasesBiomarker Evidence.

The PASADENA and PADOVA OLE studies are currently ongoing.To evaluate the long-term safety and efficacy of prasinezumab in more than 750 patients with early Parkinson's disease.

Levi Garraway, MD, Chief Medical Officer and Head of Global Product Development at Roche, stated: "The efficacy signals observed in the two Phase II trials and their open-label extension studies, combined with the favorable safety and tolerability profile of prasinezumab, are highly encouraging. We also recognize the significant unmet need for new treatment options, and all data suggest that prasinezumab has the potential to become the first disease-modifying therapy for patients with Parkinson's disease."

Prasinezumab is Roche's product from December 2013Moon FromA product introduced by Prothenaα-Syn Monoclonal Antibody, Total Transaction Amount Up To$600 million。

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