Roche to advance prasinezumab into phase III development for early-stage Parkinson's disease

Overview

Roche announced its decision to proceed with phase III development of prasinezumab, an investigational anti-alpha-synuclein antibody, in early-stage Parkinson’s disease. This decision is informed by data from the phase IIb PADOVA study and ongoing open-label extensions (OLEs) of PADOVA and phase II PASADENA studies.

Statement from the CMO: Roche

• We are encouraged by the efficacy signals observed across the two phase II trials and their open-label extensions, combined with the favourable safety and tolerability profile of prasinezumab,"" said Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development at Roche. 
• 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 Parkinson’s disease.

PADOVA and OLE studies endpoints

• Multiple endpoints from the PADOVA and OLE studies suggest a potential clinical benefit of prasinezumab when added to effective symptomatic treatment in early-stage Parkinson’s disease. 
• Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression, although missed statistical significance. 
• Positive trends towards reduced motor progression at 104 weeks (two years) were observed; these effects appear to be sustained over longer treatment periods based on additional OLE data. 
• The PADOVA study also provided the first biomarker evidence of prasinezumab impacting the underlying disease biology.

Current studies for Parkinson’s disease

The PASADENA and PADOVA OLE studies, which are evaluating the long-term safety and efficacy of prasinezumab in over 750 people with early-stage Parkinson’s disease, are ongoing.

The monoclonal antibody: Prasinezumab

• Prasinezumab is an investigational monoclonal antibody designed to bind aggregated alpha-synuclein and thereby reduce neuronal toxicity. 
• By reducing the build-up of alpha-synuclein protein in the brain, prasinezumab can potentially prevent further accumulation and spreading between cells, which may slow progression of the disease.

Clinical benefits of prasinezumab

• Data from the phase IIb PADOVA study suggest the possible clinical benefit of prasinezumab on top of effective symptomatic treatment in early-stage Parkinson’s disease. 
• PADOVA 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], although the study missed statistical significance (p=0.0657). 
• 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], p=0.0431 (nominal). 
• Consistent positive trends across multiple secondary and exploratory endpoints were also observed. 
• Trends towards reduced motor progression at 104 weeks (two years) were observed, showing 30-40% relative reduction versus placebo across the overall and levodopa-treated populations.

Prasinezumab: safety parameters

• Prasinezumab continues to be well tolerated and no new safety signals were observed in the study. 
• The safety database for prasinezumab consists of data from more than 900 Parkinson’s disease study participants that have been treated with the investigational medicine, of which more than 750 remain in open label treatment with over 500 treated for 1.5-5 years.

Agreement between Roche & Prothena

Roche entered into a licensing, development, and commercialisation agreement with Prothena in December 2013 to develop and commercialise monoclonal antibodies targeting aggregated alpha-synuclein, such as prasinezumab, for the treatment of Parkinson’s disease.

About the condition: Parkinson's disease

• Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disease characterised by the gradual loss of neurons that make dopamine and other nerve cells. 
• Today, Parkinson’s disease affects over 10 million people worldwide. 
• The prevalence of Parkinson’s disease is increasing, and it has become one of the fastest-growing neurological disorders. 
• Currently, symptomatic treatments that effectively alleviate motor symptoms are available. 
• However, there are no therapies that slow down or stop the clinical progression of Parkinson’s disease.

Roche’s work on stoping the disease progression

Roche is evaluating multiple approaches to stop or slow disease progression and potentially prevent Parkinson’s disease by targeting underlying disease processes such as the accumulation of aggregated alpha-synuclein production, lysosomal dysfunction and neuroinflammation.

Roche’s Commitment to Neurological Research

• Focused on groundbreaking neurological science and innovation.
• Developing advanced diagnostic solutions for early disease detection.
• Creating new treatments for chronic and debilitating neurological conditions.
• Utilizing pharmaceutical and diagnostic expertise for better patient outcomes.
• Striving to prevent neurological diseases through early intervention and research.
• Collaborating globally to accelerate progress in neurological healthcare.

Roche’s work on neurological disorders

• Roche is investigating more than a dozen medicines for neurological disorders, including Alzheimer’s disease, multiple sclerosis, spinal muscular atrophy, Duchenne muscular dystrophy, Parkinson’s disease, neuromyelitis optica spectrum disorder and Huntington’s disease. 
• Roche diagnostics offers one of the broadest portfolio of solutions, including approved and investigational tools, such as digital and blood-based tests and CSF assays, aiming to more effectively detect, diagnose and monitor the disease. 
• Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today.

About the company: Roche

• Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. 
• The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!