First-In-Human Assessment of PRX002, Prothena's Anti-Alpha Synuclein Antibody for Parkinson's Disease, Published in Movement Disorders Journal
(Thomson Reuters ONE) -
Data Previously Presented in 2015 at 19th International Congress of Parkinson's
Disease and Movement Disorders
DUBLIN, Ireland, Dec. 13, 2016 (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 the publication of previously disclosed clinical results from a
Phase 1 single ascending dose study in healthy volunteers of PRX002, a
monoclonal antibody for the potential treatment of Parkinson's disease and other
related synucleinopathies, in the peer-reviewed journal Movement Disorders.
PRX002, also known as RG7935, is the focus of a worldwide collaboration between
Prothena and Roche.
The data, which was previously presented in June 2015 as part of the late
breaking oral session at the 19th International Congress of Parkinson's Disease
and Movement Disorders, demonstrated that PRX002 was generally safe and well-
tolerated in healthy volunteers, meeting the primary objective of the study.
Further, results from this study showed that administration of PRX002 led to a
mean reduction of free serum alpha-synuclein levels of up to 96.5 percent within
one hour of the completion of infusion. These overall results were statistically
significant (p < 0.0001). Reduction of free serum alpha-synuclein was shown to
be robust, rapid, and dose- and time-dependent after a single dose.
The Phase 1 double-blind, placebo-controlled, single ascending dose study
enrolled 40 healthy volunteers across five escalating dose cohorts to receive
either PRX002 or placebo. No serious adverse events or hypersensitivity
reactions were reported. PRX002 demonstrated favorable pharmacokinetic
properties. The most common treatment emergent adverse events were headache,
nausea, vessel puncture site pain, viral infection, and viral upper respiratory
tract infection. In this study, all PRX002-related adverse events were mild, no
dose limiting toxicities were observed and no anti-drug antibodies were
detected.
About Alpha-synuclein
Alpha-synuclein is a protein found in neurons and 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 is a monoclonal antibody under development for the potential treatment of
Parkinson's disease. PRX002 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 in
various cellular and animal models of alpha-synuclein-related disease. In
multiple transgenic mouse models of Parkinson's disease, passive immunization
with 9E4, the murine version of PRX002, 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. Prothena has an option to co-promote PRX002 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 and will pay Prothena up to double-digit royalties on net
sales. A Phase 2 clinical study of PRX002 in patients with Parkinson's disease
is expected to begin in 2017.
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
seeking to fundamentally change the course of progressive diseases with its
clinical pipeline of novel therapeutic antibodies. 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 is establishing a fully integrated research,
development and commercial focus and has advanced several drug candidates into
clinical studies while pursuing discovery of additional novel therapies. Our
pipeline of antibody-based product candidates targets a number of potential
indications including AL amyloidosis (NEOD001), Parkinson's disease and other
related synucleinopathies (PRX002), inflammatory diseases, including psoriasis
and psoriatic arthritis (PRX003), and ATTR amyloidosis (PRX004). 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, plans for and the timing of initiating a Phase 2
clinical study of PRX002; and the design of PRX002 and its potential as a
disease modifying treatment for 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 25, 2016 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.
Contacts:
Investors: Tran Nguyen, CFO
650-837-8535, IR(at)prothena.com
Media: Ellen Rose, Head of Communications
650-922-2405, ellen.rose(at)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
Unternehmensinformation / Kurzprofil:
Datum: 13.12.2016 - 22:05 Uhr
Sprache: Deutsch
News-ID 512685
Anzahl Zeichen: 9229
contact information:
Town:
DUBLIN
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 165 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"First-In-Human Assessment of PRX002, Prothena's Anti-Alpha Synuclein Antibody for Parkinson's Disease, Published in Movement Disorders Journal"
steht unter der journalistisch-redaktionellen Verantwortung von
Prothena Corporation plc (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
