Prothena Announces Initiation of Phase 2 PASADENA Study of PRX002/RG7935 in Patients with Early Parkinson's Disease
July 05 2017 - 4:05PM
- First
potentially disease-modifying anti-alpha-synuclein antibody to be
evaluated for efficacy in patients with Parkinson's
disease
- Prothena to
receive $30 million milestone payment under collaboration agreement
with Roche
DUBLIN, Ireland, July 05, 2017
(GLOBE NEWSWIRE) -- Prothena Corporation plc (Nasdaq:PRTA), a
late-stage clinical biotechnology company focused on the discovery,
development and commercialization of novel protein immunotherapies,
today announced that the first patient has been enrolled in
PASADENA, a global Phase 2 study of PRX002/RG7935 in patients with
early Parkinson's disease. PRX002/RG7935 is an anti-alpha-synuclein
antibody under investigation as a disease-modifying treatment for
Parkinson's disease and is the focus of a worldwide collaboration
between Prothena and Roche. The start of the study triggered a $30
million milestone from Roche to Prothena, which was earned in the
second quarter of 2017. Prothena had previously received $45
million in upfront and development milestone payments.
"Building upon the data from two
completed Phase 1 studies of PRX002/RG7935, which demonstrated
favorable safety, tolerability and pharmacologic properties, the
Phase 2 study will evaluate the impact of targeting alpha-synuclein
on the slowing of progression of Parkinson's disease in patients,"
stated Gene Kinney, PhD, President & Chief Executive Officer of
Prothena. "Two dose levels have been selected for the Phase 2 study
of PRX002/RG7935 that, based on our preclinical and clinical data,
we expect to meaningfully reduce pathogenic alpha-synuclein in the
brains of patients with Parkinson's disease."
Phase 2
PASADENA Study Design
PASADENA is a two-part Phase 2
clinical study in early Parkinson's disease patients that is being
conducted by Roche. Part 1 is a randomized, double-blind,
placebo-controlled, three-arm study designed to enroll
approximately 300 patients to evaluate the efficacy and safety of
PRX002/RG7935 in patients over 52 weeks. In part 1, patients will
be randomized on a 1:1:1 basis to receive one of two active doses
(1500 mg or 4500 mg) of PRX002/RG7935 or placebo via intravenous
infusion once every 4 weeks. Eligible patients must not be on
dopaminergic therapy and must not be expected to require
dopaminergic therapy for at least 52 weeks. Part 2 of the study is
a 52-week blinded extension phase in which patients from the
placebo arm of the study will be re-randomized onto one of two
active doses on a 1:1 basis, so that all participants will be on
active treatment. Patients who were originally randomized to an
active dose will continue at that dose level for the additional 52
weeks. In part 2, patients will be allowed to use concomitant
dopaminergic therapy. Any patient who medically requires initiation
of dopaminergic therapy during part 1 will have their subsequent
data censored for the primary endpoint analysis.
The primary endpoint of this study
is the comparison of change from baseline in the Movement Disorder
Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total
score (sections 1, 2 and 3) at the completion of part 1 (week 52)
in each treatment group vs. the placebo group. The study is
designed with 80 percent power and a one-sided alpha of 0.10 to
detect a 37.5 percent relative between group reduction from
baseline to week 52. A prespecified exploratory analysis will
compare the results of the two pooled treatment arms vs. placebo.
Key secondary endpoints include safety, tolerability and DaT-SPECT
imaging.
For more information on the Phase
2 PASADENA study, please visit clinicaltrials.gov and search NCT
#03100149.
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 generally 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 an infection-like spread 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/RG7935
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 will have 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 in clinical, regulatory and
sales milestones. For more information on the Phase 2 clinical
study of PRX002/RG7935 in patients with Parkinson's disease, visit
clinicaltrials.gov and search NCT #03100149.
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
global, late-stage clinical biotechnology company establishing
fully-integrated research, development and commercial capabilities.
Fueled by its deep scientific understanding built over decades of
research in protein misfolding and cell adhesion - the root causes
of many serious or currently untreatable amyloid and inflammatory
diseases - Prothena seeks to fundamentally change the course of
progressive diseases associated with this biology. The Company's
pipeline of antibody therapeutic candidates targets a number of
indications including AL amyloidosis (NEOD001), Parkinson's disease
and other related synucleinopathies (PRX002/RG7935), inflammatory
diseases, including psoriasis and psoriatic arthritis (PRX003), and
ATTR amyloidosis (PRX004). The Company continues discovery of
additional novel therapeutic candidates where its deep scientific
understanding of disease pathology can be leveraged. For more
information, please visit the Company's website
at www.prothena.com
Forward-looking
Statements
This press
release contains forward-looking statements. These statements
relate to, among other things, whether the PRX002/RG7935 dose levels in the Phase 2 study
will meaningfully reduce pathogenic alpha-synuclein in the brain of
patients with Parkinson's disease; the design of PRX002/RG7935 and
its potential as a disease-modifying antibody for patients with
Parkinson's disease. 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 27, 2017 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.
Media & Investor Contact:
Ellen Rose, Head of Communications
650-922-2405, ellen.rose@prothena.com
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Prothena Corporation plc via Globenewswire
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