Roche-Prothena Partnered Mid-Stage Parkinson's Trial Misses Primary Endpoint, But Cling On Signs Of Clinical Benefits

On Thursday, Prothena Corporation plc PRTA released results from the Phase 2b PADOVA study of prasinezumab in early-stage Parkinson’s disease.

Partner Roche Holdings AG RHHBY conducted the 586-subject study investigating prasinezumab in early-stage Parkinson’s disease patients who had been treated for a minimum of 18 months while on stable symptomatic treatment.

Prasinezumab showed a potential clinical effect in the primary endpoint of time to confirmed motor progression with an HR=0.84 and p=0.0657, missing statistical significance.

The companies said the effect of prasinezumab was more pronounced in a pre-specified analysis in the population treated with levodopa (75% of participants), HR=0.79 and nominal p=0.0431.

Pre-specified supplementary covariate-adjusted analyses of these endpoints demonstrated nominally significant effects on the primary endpoint (HR=0.81; nominal p=0.0334) and in the levodopa subgroup (HR=0.76; nominal p=0.0175).

Consistent positive trends across multiple secondary and exploratory endpoints were also observed. Prasinezumab continues to be well tolerated, and no new safety signals were observed in the study.

The Phase 2 PASADENA and Phase 2b PADOVA open-label extension studies will continue to explore the observed effects in both studies.

Roche will continue to evaluate the data and work together with health authorities to determine the next steps.

Full results from the PADOVA study will be presented at an upcoming medical meeting.

Price Action: PRTA stock is up 32.40% at $15.83 at the last check on Thursday.

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