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Prothena Announces Updated Timing of Presentation for Phase 2 PASADENA Study Results at International Congress of Parkinson’s Disease and Movement Disorders

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Prothena Corporation (NASDAQ: PRTA) updated the presentation timing for results from Part 1 of the Phase 2 PASADENA study involving prasinezumab for early Parkinson's disease. The oral presentation, originally set for September 14, will now be on September 15 at the 2020 International Congress of Parkinson’s Disease and Movement Disorders Society. Prasinezumab, a humanized monoclonal antibody, targets alpha-synuclein to potentially slow clinical decline in Parkinson's patients. Prothena has partnered with Roche for its development, sharing costs and profits on a 30/70 basis.

Positive
  • The oral presentation of PASADENA Phase 2 study results will take place on September 15, showcasing Prothena's ongoing research in Parkinson's disease.
  • Prasinezumab targets alpha-synuclein, potentially addressing an underlying cause of Parkinson's disease.
  • Prothena has earned $75 million in milestone payments related to prasinezumab.
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  • None.

DUBLIN, Ireland, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage company with expertise in protein dysregulation and a diverse pipeline of investigational therapeutics for neurodegenerative and rare peripheral amyloid diseases, today announced updated timing for the presentation of results from Part 1 of the Phase 2 PASADENA study of prasinezumab in early Parkinson’s disease. As previously announced, results from Part 1 of the Phase 2 PASADENA study of prasinezumab were selected as an oral Top Abstract presentation at the upcoming Virtual 2020 International Congress of Parkinson’s Disease and Movement Disorders Society (MDS Congress). The presentation was previously scheduled for September 14 and will now take place on September 15 in a session on Immunotherapies for Proteinopathies.

Details for the updated date and time for this oral Top Abstract session are as follows:

  • Session 902: Immunotherapy for Proteinopathies
  • PASADENA: A Phase 2 study to evaluate the safety and efficacy of prasinezumab in early Parkinson’s disease; Part 1 Week-52 results
  • Presenter: Gennaro Pagano, MD, MSc, PhD, Senior Principal Medical Director, Translational Medicine, Neuroscience and Rare Diseases Discovery and Translational Area, Roche Pharma Research and Early Development
  • Session Launch Date and Time: Tuesday, September 15, 2020; 14:30 – 16:30 GMT
  • Session type: Science of Industry (non-CME)

A poster regarding PASADENA results will also be included in the Virtual Poster Hall during the MDS  Congress.   

As previously announced, Wagner Zago, PhD, Prothena’s Chief Scientific Officer, will also present as part of this same session. Dr. Zago will speak on the topic of the current status of clinical trials of immunotherapies for the treatment of movement disorders.

About Prasinezumab

Prasinezumab is a humanized monoclonal antibody under development for the potential treatment of Parkinson's disease. Prasinezumab targets alpha-synuclein and is designed to block the cell-to-cell transmission of the aggregated pathogenic forms of alpha-synuclein in Parkinson's disease, thereby slowing clinical decline. Prior to initiating clinical trials, the efficacy of prasinezumab was evaluated in various cellular and animal models of alpha-synuclein-related disease. In alpha-synuclein transgenic mice, the murine version of prasinezumab reduced the appearance of alpha-synuclein pathology, protected synapses and halted the worsening of behavioral phenotypes. In December 2013, Prothena and Roche entered into a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including prasinezumab. Prothena has an option to co-promote prasinezumab in the U.S., where the companies share all development and commercialization costs, as well as profits, on a 30/70 basis (30 percent Prothena, 70 percent Roche). Outside the U.S., Roche has sole responsibility for developing and commercializing prasinezumab and has agreed to pay Prothena up to double-digit royalties on net sales. To date, Prothena has earned $75 million of a total potential $600 million in milestone payments that includes clinical, regulatory and sales milestones. For more information on the Phase 2 PASADENA clinical study of prasinezumab in patients with early Parkinson's disease, visit clinicaltrials.gov and search NCT #03100149.

About Parkinson's Disease

Parkinson's disease is a progressive degenerative disorder of the entire nervous system that affects one in 100 people over age 60. An estimated seven to 10 million people are living with Parkinson's disease worldwide. It is the second most common neurodegenerative disorder after Alzheimer's disease. The disease is characterized by the neuronal accumulation of aggregated alpha-synuclein in the CNS and peripheral nervous system that results in a wide spectrum of worsening progressive motor and non-motor symptoms. While diagnosis relies on motor symptoms classically associated with Parkinson's disease, non-motor symptoms may present many years earlier. Current treatments for Parkinson's disease are symptomatic and only address a subset of symptoms such as motor impairment, dementia, or psychosis. There are currently no treatments available that target the underlying cause of the disease and can slow or stop the progression.     

About Prothena

Prothena Corporation plc is a clinical-stage company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s partnered programs include prasinezumab (PRX002/RG7935), in collaboration with Roche for the potential treatment of Parkinson’s disease and other related synucleinopathies, and programs that target tau, TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD) or other neurodegenerative diseases. Prothena’s wholly-owned programs include PRX004 for the potential treatment of ATTR amyloidosis, and programs that target Aβ (Amyloid beta) for the potential treatment of Alzheimer’s disease. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.

Forward-Looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the treatment potential and proposed mechanisms of action of prasinezumab and the expected timing of reporting data from the Phase 2 clinical study of prasinezumab. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the effects on our business of the worldwide COVID-19 pandemic and the risks, uncertainties and other factors described in the “Risk Factors” sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 3, 2020, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. Prothena undertakes no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in Prothena’s expectations.

Media and Investor Contact:

Ellen Rose, Head of Communications
650-922-2405, ellen.rose@prothena.com


FAQ

What are the updated results presentation dates for the PASADENA study of prasinezumab?

The results will now be presented on September 15, 2020, at the 2020 International Congress of Parkinson’s Disease and Movement Disorders Society.

What is prasinezumab and what is its purpose?

Prasinezumab is a humanized monoclonal antibody intended for the treatment of early Parkinson's disease, targeting alpha-synuclein to slow disease progression.

Who will present the PASADENA study results?

Gennaro Pagano, MD, MSc, PhD, will present the results during the session on Immunotherapy for Proteinopathies.

What financial arrangements does Prothena have with Roche regarding prasinezumab?

Prothena shares development and commercialization costs and profits with Roche on a 30/70 basis, with Prothena eligible for royalties on net sales outside the U.S.

What milestone payments has Prothena received for prasinezumab?

To date, Prothena has received $75 million out of a potential $600 million in milestone payments connected to prasinezumab.

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