Roche has announced that it will be advancing its Prothena-partnered investigational Parkinson’s disease (PD) drug prasinezumab into phase 3 clinical development.
The company said it will evaluate the monoclonal antibody in patients with early stages of the neurodegenerative disorder, following results from two mid-stage trials and their ongoing open-label extensions (OLEs).
More than ten million people worldwide are living with PD, which is characterised by symptoms such as tremor, muscle rigidity, slowness of movement and difficulty with balance.
Prasinezumab aims to slow PD progression by reducing the build-up of alpha-synuclein in the brain, potentially preventing further accumulation of the protein and blocking its spread between cells.
Data from the phase 2b PADOVA study has pointed to a possible clinical benefit of prasinezumab when used on top of effective symptomatic treatment in early-stage PD, Roche said.
While the trial did not reach statistical significance on the primary endpoint of time to confirmed motor progression, prasinezumab demonstrated potential clinical efficacy, and a pre-specified analysis showed that the effect of the candidate was more pronounced in patients also receiving levodopa.
Trends towards reduced motor progression at two years were also observed, and these effects appear to be sustained over longer treatment periods based on additional OLE data, according to the company.
Roche’s chief medical officer and head of global product development, said: “We are encouraged by the efficacy signals observed across the two phase 2 trials and their OLEs, combined with the favourable safety and tolerability profile of prasinezumab.
“We also recognise the substantial need for new treatment options, and the totality of data suggest that prasinezumab may have the potential to become the first disease-modifying treatment for people with PD.”
Roche and Prothena entered into a worldwide collaboration agreement in 2013 to develop and commercialise monoclonal antibodies targeting aggregated alpha-synuclein, such as prasinezumab, for PD.
Roche is solely responsible for developing and commercialising prasinezumab, and has agreed to pay Prothena, which has an option to co-promote prasinezumab in the US, up to double-digit teen royalties on net sales.