Roche Advances Prasinezumab to Phase III for Early Parkinson’s Disease

Roche Advances Prasinezumab to Phase III for Early Parkinson's Disease

Switzerland-based Roche (SWX: ROG, OTCMKTS: RHHBY) announced its decision to advance prasinezumab, an anti-α-synuclein antibody for early-stage Parkinson’s disease, into Phase III development. This decision follows data from the Phase IIb PADOVA study and open-label extension (OLE) data from both PADOVA and the Phase II PASADENA study.

Clinical Study Results

While the primary endpoint (time to confirmed motor progression) did not achieve statistical significance, prasinezumab demonstrated potential clinical efficacy, with a positive trend in reducing motor progression observed at 104 weeks (2 years). Effects appeared to persist over longer treatment periods based on additional OLE data. PADOVA also provided the first biomarker evidence that prasinezumab may influence the underlying biology of Parkinson’s disease.

Mechanism of Action

Prasinezumab is an investigational monoclonal antibody designed to target aggregated α-synuclein, potentially reducing neurotoxicity. By decreasing the accumulation of α-synuclein in the brain, it may help prevent further cell-to-cell spread, thereby slowing disease progression.

Collaboration Background

In December 2013, Roche entered into a license, development, and commercialization agreement with Prothena to jointly develop and commercialize α-synuclein-targeting monoclonal antibodies, including prasinezumab, for Parkinson’s disease treatment.-Fineline Info & Tech