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 indicated possible Allow advantages to close. The study demonstrated a numerical delay in motor progression and positive trends in several secondary and exploratory endpoints.
According to the company, the phase IIb PADOVA trial evaluated prasinezumab in 586 people with early-stage Parkinson's disease who were on stable symptomatic treatment for at least 18 months. Prasinezumab demonstrated potential clinical efficacy in the primary endpoint of time to confirmed motor progression, with HR=0.84 [0.69-1.01] and p=0.0657, lack of statistical significance.
In a prespecified analysis, the effect of prasinezumab was greater in the levodopa-treated population (75% of participants), HR=0.79 [0.63-0.99]. Consistent positive trends were also observed across multiple secondary and exploratory endpoints. 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 are continuing to evaluate the effects observed in both studies. Roche/Genentech will continue to evaluate the data and determine the next steps together with the health authorities.
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