Data Previously Presented in 2017 at the 13th International
Conference on Alzheimer's and Parkinson's Diseases (AD/PD)
DUBLIN, Ireland, June 19, 2018
(GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a
clinical-stage biotechnology company focused on the discovery and
development of novel therapies in the neuroscience category, today
announced that results from the Phase 1b multiple ascending dose
study of PRX002/RG7935, an investigational monoclonal antibody for
the potential treatment of Parkinson's disease, has
been published in JAMA
Neurology. PRX002/RG7935 is the focus of a worldwide
collaboration between Prothena and Roche.
The data, which were previously
presented as part of a late-breaking oral session at the 13th
International Conference on Alzheimer's and Parkinson's Diseases
(AD/PD) in Vienna, Austria in April 2017, demonstrated that
PRX002/RG7935 was found to have an acceptable safety and
tolerability profile in patients with Parkinson's disease, meeting
the primary objective of this study. CNS penetration was
demonstrated by a dose-dependent increase in PRX002/RG7935 levels
in CSF, and a mean concentration of PRX002/RG7935 in CSF of 0.3
percent relative to serum across all dose levels. Additional
results showed a rapid, dose- and time dependent mean reduction of
free serum alpha-synuclein levels of up to 97 percent after a
single dose, which were statistically significant (p<0.0001),
and maintained following two additional monthly doses. The study
results supported advancing PRX002/RG7935 into
the PASADENA Phase 2 clinical study in patients with
early Parkinson's disease that is currently ongoing.
About
Alpha-synuclein
Alpha-synuclein, a protein found
in neurons and other cells, is a major component of pathology that
characterizes several neurodegenerative disorders including
Parkinson's disease, dementia with Lewy bodies, and multiple system
atrophy, which collectively are termed synucleinopathies. While the
normal function of alpha-synuclein is not well understood, the
protein normally occurs in a soluble form. In synucleinopathies,
the alpha-synuclein protein can misfold and aggregate to form
soluble aggregates and insoluble fibrils that contribute to disease
pathology. There is increasing evidence that this disease-causing
alpha-synuclein can be propagated and transmitted from neuron to
neuron, resulting in a spreading of neuronal death. Recent studies
in cellular and animal models suggest that the spread of
alpha-synuclein-associated neurodegeneration can be disrupted by
targeting aberrant forms of alpha-synuclein.
About
PRX002/RG793
PRX002/RG7935 is a monoclonal
antibody under development for the potential treatment of
Parkinson's disease. PRX002/RG7935 targets alpha-synuclein and is
designed to slow the progressive neurodegeneration associated with
alpha-synuclein misfolding and/or the cell-to-cell transmission of
the aggregated pathogenic forms of alpha-synuclein found in
Parkinson's disease and other synucleinopathies. Prior to
initiating clinical trials, Prothena demonstrated the efficacy of
PRX002/RG7935 in various cellular and animal models of
alpha-synuclein-related disease. In multiple transgenic mouse
models of Parkinson's disease, the murine version of PRX002/RG7935,
reduced the appearance of alpha-synuclein pathology, protected
synapses and improved performance in behavioral testing. In
December 2013, Prothena and Roche entered into a worldwide
collaboration to develop and commercialize antibodies that target
alpha-synuclein, including PRX002/RG7935. Prothena has an option to
co-promote PRX002/RG7935 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 PRX002/RG7935 and will pay Prothena up to
double-digit royalties on net sales. To date, Prothena has earned
$75 million of a potential $600 million that includes clinical,
regulatory and sales milestones. For more information on the Phase
2 PASADENA clinical study of PRX002/RG7935 in patients with
Parkinson's disease, visit clinicaltrials.gov and search NCT
#03100149 or visit www.pasadenastudy.com.
About
Parkinson's Disease
Parkinson's disease is a
progressive degenerative disorder of the central nervous system
(CNS) that affects one in 100 people over age 60. With an estimated
seven to 10 million patients 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. Symptomatic therapies do not target the underlying cause
of the disease and lose effectiveness, often leading to
debilitating side effects as the disease progresses.
About
Prothena
Prothena Corporation plc is a
clinical-stage biotechnology company focused on the discovery and
development of novel therapies with the potential to fundamentally
change the course of progressive, life-threatening diseases in the
neuroscience category. Fueled by its deep scientific understanding
built over decades of neuroscience research, Prothena is advancing
a pipeline of therapeutic candidates for a number of indications
and novel targets including Parkinson's disease and other related
synucleinopathies (PRX002/RG7935) and ATTR amyloidosis (PRX004), as
well as tau, AB (Amyloid beta) and TDP-43 where its scientific
understanding of disease pathology can be leveraged. For more
information, please visit the Company's website at www.prothena.com
and follow us on Twitter @ProthenaCorp.
Forward-Looking
Statements
This press
release contains forward-looking statements. These statements
relate to, among other things, the
design of PRX002/RG7935, its proposed mechanism of action and its
potential as a treatment for Parkinson's disease; how
disease-causing alpha-synuclein might spread and how it might be
disrupted; and amounts we might earn under our collaboration with
Roche. 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 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 (SEC) on February 26, 2018 and our subsequent Quarterly
Reports on Form 10-Q filed with the SEC. 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.
Investor and
Media Contact:
Ellen Rose, Head of
Communications
650-922-2405, ellen.rose@prothena.com