Prothena Highlights Breadth of Novel Pipeline at R&D Day
November 16 2017 - 8:00AM
Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical
biotechnology company focused on the discovery, development and
commercialization of novel protein immunotherapies, will provide an
update on the Company's growing research and development pipeline
of first-in-class therapies in the neuroscience and orphan disease
categories during an R&D Day hosted today in New York City.
Prothena management, including Gene Kinney, PhD,
President & CEO; Sarah Noonberg, MD, PhD, Chief Medical Officer
and Wagner Zago, PhD, Chief Scientific Officer, will discuss
progress on Prothena’s clinical and discovery programs. Independent
subject matter expert Morie Gertz, MD, Chair Emeritus of the
Department of Internal Medicine at Mayo Clinic in Rochester, Minn.,
will discuss the current AL amyloidosis treatment landscape, unmet
medical need and use of NT-proBNP, a cardiac biomarker shown to be
predictive of survival in the treatment of patients with AL
amyloidosis.
“R&D Day is an opportunity to provide
additional insight into our clinical development programs that are
advancing toward key milestones, and also to highlight our growing
discovery pipeline of innovative approaches for neuroscience and
orphan diseases,” stated Gene Kinney, PhD, President and Chief
Executive Officer of Prothena.
Clinical Pipeline
Highlights
During R&D Day, Prothena will discuss its
clinical development pipeline of first-in-class protein
immunotherapies including the following program highlights:
NEOD001 is an investigational
first-in-class antibody that specifically targets disease-causing
misfolded light chain in AL amyloidosis. There are two ongoing
late-stage global clinical studies of NEOD001.
- The Phase 2b PRONTO study of previously treated patients with
AL amyloidosis and cardiac dysfunction is evaluating best cardiac
response over 12 months based on reduction of the cardiac biomarker
NT-proBNP, and topline results are expected in the second quarter
of 2018. Key baseline characteristics of patients enrolled in the
Phase 2b PRONTO study are similar to baseline characteristics of
patients in the Phase 1/2 study.
- The Phase 3 VITAL study of newly diagnosed, treatment naive
patients with AL amyloidosis and cardiac dysfunction is evaluating
a composite endpoint of time to all-cause mortality or cardiac
hospitalization. Baseline characteristics of patients enrolled in
the Phase 3 VITAL study support the evaluation of NEOD001 effect on
morbidity and mortality.
PRX002/RG7935 is an
investigational first-in-class antibody targeting alpha-synuclein
for the potential treatment of Parkinson’s disease and is the
subject of a worldwide collaboration with Roche. The Phase 2
PASADENA study in patients with early Parkinson’s disease was
initiated in the second quarter of this year and enrollment is
ongoing.
PRX004 is an investigational
first-in-class antibody that specifically targets disease-causing
misfolded transthyretin in ATTR amyloidosis.
- Phase 1 study of PRX004 in patients with ATTR amyloidosis is
expected to initiate by mid-2018.
- Prothena will discuss a proprietary, high-sensitivity assay
that specifically detects circulating misfolded-hATTR in plasma
across multiple TTR mutations and that can be used in clinical
studies to monitor pharmacodynamic response to PRX004 in
plasma.
Discovery Pipeline
Highlights
“Our disciplined approach to advancing new
compounds from discovery into clinical development is based on a
deep understanding of how to optimally target proteins, assess
target engagement and disease progression and develop antibodies
that relevantly influence biology,” continued Dr. Kinney. “Beyond
the catalysts in our clinical programs, we look forward to
advancing our exciting discovery pipeline of novel approaches in
the neuroscience and orphan areas including targets such as tau,
ALECT2, TDP-43, beta amyloid, and others that are implicated in
devastating diseases that lack effective therapies such as
Alzheimer’s disease (AD), ALECT2 amyloidosis, frontotemporal
dementia (FTD) and amyotrophic lateral sclerosis (ALS).”
During R&D Day Prothena will also discuss a
number of its discovery-stage programs in the neuroscience and
orphan disease categories including:
- Tau, a protein implicated in diseases
including Alzheimer’s disease (AD), progressive supranuclear palsy
(PSP), frontotemporal dementia (FTD) and chronic traumatic
encephalopathy (CTE). Prothena has identified antibodies
targeting novel epitopes on the tau protein with the ability to
block misfolded tau from binding to cells and to inhibit
cell-to-cell transmission, preventing downstream functional
effects.
- LECT2, a protein implicated in ALECT2
amyloidosis. Similar to AL amyloidosis and ATTR amyloidosis, ALECT2
amyloidosis is a rare disease caused by deposits of misfolded
aggregated protein in vital organs, most often the kidneys and
liver. Prothena has identified novel epitopes on the misfolded
forms of the protein.
Webcast Details
Prothena will host R&D Day today from 12:00
- 2:00 PM ET in New York, NY. For those not able to attend, a live
webcast that will include audio and slides of the presentation can
be accessed through the Investors section of the Company's website
at www.prothena.com. Following the live presentations, a replay of
the webcast will be available on the Company's website for at least
90 days.
About Prothena
Prothena Corporation plc is a global, late-stage
clinical biotechnology company establishing fully integrated
research, development and commercial capabilities and focused on
advancing new therapies in the neuroscience and orphan arenas.
Fueled by its deep scientific understanding built over decades of
research in protein misfolding, Prothena seeks to fundamentally
change the course of grave or currently untreatable diseases
associated with this biology. Prothena’s pipeline of antibody
therapeutic candidates targets a number of indications including AL
amyloidosis (NEOD001), Parkinson’s disease and other related
synucleinopathies (PRX002/RG7935) 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, the
predictive value of the cardiac biomarker NT-proBNP; the timing of
announcing topline results from the Phase 2b PRONTO study of
NEOD001; the timing of initiating a Phase 1 study of PRX004; our
expectations on a new assay for detecting circulating
misfolded-hATTR in plasma; our ability to advance a growing
pipeline of novel first-in-class therapies in neuroscience and
orphan diseases; and the potential targeting of novel epitopes we
have identified on misfolded forms of tau protein and on misfolded
forms of LECT2 protein. 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 Communications650-922-2405,
ellen.rose@prothena.com
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