SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of the Roche Group (RHHBY), announced that its phase IIb study of Prasinezumab in early-stage Parkinson's disease missed the primary endpoint, but data suggested possible benefits. The study showed a numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints.
According to the company, the Phase IIb PADOVA study investigated prasinezumab in 586 people with early-stage Parkinson's disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01] and p=0.0657, missing statistical significance.
In a pre-specified analysis, the effect of prasinezumab was more pronounced in the population treated with levodopa (75% of participants), HR=0.79 [0.63-0.99]. 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 company noted that the Phase II PASADENA and Phase IIb PADOVA open-label extension studies will continue in order to explore the observed effects in both studies. Roche/Genentech will continue to evaluate the data and work together with health authorities to determine next steps.
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