Prothena Corporation plc : Press Release
(Thomson Reuters ONE) -
Clinical Results Presented from Prothena's Phase 1b Study of PRX002/RG7935
Demonstrating Robust Antibody CNS Penetration and Significant Reduction of Free
Serum Alpha-synuclein in Patients with Parkinson's Disease
* All dose levels of PRX002/RG7935 found to have an acceptable safety and
tolerability profile, meeting the primary objective of this study
* Robust central nervous system (CNS) penetration demonstrated by a dose-
dependent increase in PRX002 levels in cerebrospinal fluid (CSF), and mean
concentration of PRX002 in CSF of 0.3 percent relative to serum across all
dose levels
* Rapid, dose- and time-dependent mean reduction in levels of free serum
alpha-synuclein of up to 97 percent
* Results support advancing PRX002 into Phase 2 clinical study, PASADENA,
planned to begin in the second quarter of 2017
* Study Results Presented in Late Breaking Oral Session at 13th International
Conference on Alzheimer's and Parkinson's Diseases (Symposium 58) in Vienna
* Joseph Jankovic, MD, Professor of Neurology, Distinguished Chair in Movement
Disorders at Baylor College of Medicine to present results during Prothena's
investor conference call and webcast today at 9:00 AM ET
DUBLIN, Ireland, April 02, 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 presented clinical results from its Phase 1b multiple ascending dose study
of PRX002/RG7935 in patients with Parkinson's disease. PRX002, also known as
RG7935, is an antibody under investigation as a potentially disease-modifying
treatment for Parkinson's disease and is the focus of a worldwide collaboration
between Prothena and Roche.
The study results were 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 today at 6:00 AM ET (12:00 PM CET), by Joseph Jankovic, MD,
Professor of Neurology, Distinguished Chair in Movement Disorders at Baylor
College of Medicine, Houston, Texas, and are also being discussed today in an
investor webcast at 9:00 AM ET.
As highlighted in the November 2016 topline press release, 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. Robust 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.
"PRX002/RG7935 represents a promising investigational approach as a disease-
modifying immunotherapy designed to target the toxic form of alpha-synuclein
that accumulates in Parkinson's disease patients," stated Joseph Jankovic, MD,
Professor of Neurology, Distinguished Chair in Movement Disorders, and Director
of the Parkinson's Disease Center and Movement Disorders Clinic at Baylor
College of Medicine. "The Parkinson's disease community is looking forward to
the start of the Phase 2 clinical study that will assess how targeting alpha-
synuclein may translate into a clinically meaningful delay of disease
progression in patients."
"The safety, tolerability and pharmacologic properties of PRX002/RG7935 have now
been demonstrated in two double-blind, placebo-controlled Phase 1 studies, which
collectively enrolled 120 individuals. Based on these study results we are able
to initiate a Phase 2 study with dose levels that we expect to meaningfully
reduce pathogenic alpha-synuclein in the brain of patients suffering with
Parkinson's disease," stated Gene Kinney, PhD, President & Chief Executive
Officer of Prothena. "Together with Roche, we plan to initiate PASADENA, a
global Phase 2 study in the second quarter of this year to further explore the
potential of PRX002/RG7935 as a disease-modifying therapy for Parkinson's
disease."
This Phase 1b double-blind, placebo-controlled multiple ascending dose study
enrolled 80 patients with Parkinson's disease. Patients were randomized into six
escalating dose cohorts to receive PRX002/RG7935 or placebo (2:1 randomization
for 0.3, 1, 3 or 10 mg/kg, and 3:1 randomization for 30 or 60 mg/kg). In this
six-month study, patients received three monthly doses (intravenous infusion
once every 28 days) of PRX002/RG7935 or placebo and were followed for an
observational period of three months. No serious or severe treatment emergent
adverse events (TEAEs) were reported in PRX002/RG7935 treated patients. No TEAEs
were observed in ten percent or more of PRX002/RG7935 treated patients. TEAEs
greater than placebo in five percent or more of PRX002/RG7935 treated patients,
regardless of relationship to PRX002/RG7935, included constipation, infusion
related reactions (IRRs), diarrhoea, peripheral oedema, and post lumbar puncture
syndrome. Mild-to-moderate IRRs, that all resolved, were limited to the 60 mg/kg
dose cohort and were observed in four of 12 treated patients. No dose-limiting
toxicities were observed. PRX002/RG7935 demonstrated acceptable pharmacokinetic
properties.
PASADENA, a Phase 2 study of PRX002/RG7935 of approximately 300 patients with
early Parkinson's disease is expected to initiate in the second quarter of 2017.
Conference Call and Webcast Details
Dr. Joseph Jankovic of the Baylor College of Medicine will join Prothena
management to discuss the clinical study results from the Phase 1b multiple
ascending dose study of PRX002/RG7935 during a live audio webcast and conference
call today, April 2, 2017, at 9:00 AM ET. The webcast and slide presentation
will be made available on the Company's website at www.prothena.com under the
Investors tab in the Events and Presentations section. Following the live audio
webcast, a replay of the webcast will be available on the Company's website for
90 days.
To access the conference call via dial-in, please dial (877) 887-5215 (U.S. toll
free) or (315) 625-3069 (international) five minutes prior to the start time and
refer to conference ID number 85230691. A replay of the webcast and call will be
available until April 9, 2017 via dial-in at (855) 859-2056 (U.S. toll free) or
(404) 537-3406 (international), Conference ID Number 85230691.
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. A Phase 2 clinical study of
PRX002/RG7935 in patients with Parkinson's disease is expected to begin in the
second quarter of 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
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, plans for and the timing of initiating a Phase 2
clinical study of PRX002/RG7935; whether the Phase 2 study will show meaningful
reduction in pathogenic alpha-synuclein in the brain; and the design
of PRX002/RG7935 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
27, 2017 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: 02.04.2017 - 14:00 Uhr
Sprache: Deutsch
News-ID 533876
Anzahl Zeichen: 14013
contact information:
Town:
DUBLIN
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 272 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Prothena Corporation plc : Press Release"
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).
