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Roche RHHBY announced data from the phase IIb PADOVA study which evaluated its investigational monoclonal antibody, prasinezumab, for treating people with early-stage Parkinson’s disease.
The double-blind PADOVA study evaluated the safety and efficacy of prasinezumab versus placebo in 586 randomized patients with early-stage Parkinson’s disease who were on stable symptomatic treatment.
The study missed the primary endpoint.
Data from the study showed that treatment with prasinezumab demonstrated potential clinical efficacy in the primary endpoint of time to confirmed motor progression, missing statistical significance.
Year to date, shares of Roche have lost 3.6% against the industry's growth of 6.6%.
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More on RHHBY's PADOVA Study
Although the PADOVA study missed the primary endpoint, treatment with prasinezumab indicated possible benefits in early-stage Parkinson’s disease, a progressive degenerative disorder of the central nervous system.
Per management, in a pre-specified analysis, the effect of prasinezumab was more pronounced in the population treated with levodopa.
Data from the study also demonstrated positive trends across multiple secondary and exploratory endpoints.
Treatment with prasinezumab continues to be well tolerated with no new safety signals observed either.
The company is further evaluating the data from the PADOVA study and is looking to work with health authorities to determine the next steps of development for prasinezumab.
RHHBY's Deal With Prothena to Develop Prasinezumab
In late 2013, Roche entered into a licensing agreement with Prothena PRTA for the development and commercialization of selected antibodies targeting alpha-synuclein, including prasinezumab.
PRTA earned a $60 million milestone payment upon dosing the first patient in the phase IIb PADOVA study for prasinezumab in early-stage Parkinson’s disease.
The phase II PASADENA study is also investigating prasinezumab in patients with early Parkinson’s disease.
RHHBY's Zacks Rank & Key Picks
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector are Castle Biosciences, Inc. CSTL and Spero Therapeutics, Inc. SPRO, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Castle Biosciences’ 2024 bottom line have moved from a loss of 59 cents to earnings of 34 cents. Loss per share estimates for 2025 have narrowed from $2.15 to $1.84 during the same time. Year to date, shares of CSTL have surged 22.9%.