Prothena Announces Achievement of $60 Million Milestone From Roche for First Patient Dosed in Phase 2b Study of Prasinezumab ...
May 10 2021 - 4:05PM
Prothena Announces Achievement of $60 Million Milestone From Roche
for First Patient Dosed in Phase 2b Study of Prasinezumab in Early
Parkinson’s Disease
Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical
company with a robust pipeline of novel investigational
therapeutics built on protein dysregulation expertise, today
announced that the Company has earned a $60 million milestone from
its worldwide collaboration with Roche based on the first patient
dosed in the Phase 2b PADOVA study of prasinezumab in patients with
early Parkinson's disease. Prothena has previously received $75
million in payments from Roche as part of this collaboration.
Prasinezumab is the first anti-alpha synuclein
antibody to advance into late-stage clincal development. Results
from the Phase 2 PASADENA study, reported in September 2020,
demonstrated signals of efficacy on multiple pre-specified
secondary and exploratory clinical endpoints, including measures of
motor function and biomarkers, in patients with early Parkinson’s
disease. These signals of efficacy add to the growing body of
evidence that optimally targeting an appropriate epitope within
pathogenic proteins, such as alpha-synuclein and abeta, results in
clinically meaningful benefits for patients. Roche’s advancement of
prasinezumab into this Phase 2b PADOVA study is an important step
forward for this first-in-class compound, with the potential to
slow the progression of Parkinson’s disease and positively impact
the lives of millions of patients.
Phase 2b PADOVA Study
Design
Based on positive signals of efficacy consistent
with disease modification in the Phase 2 PASADENA study,
prasinezumab is being advanced into the Phase 2b PADOVA study to
further assess the efficacy and safety of prasinezumab in an
expanded patient population. PADOVA is a Phase 2b, randomized,
double-blind, placebo-controlled, multicenter study designed to
evaluate the efficacy and safety of prasinezumab in patients with
early Parkinson’s disease who are on stable symptomatic medication.
The study will enroll approximately 575 patients, who will be
randomized to receive either prasinezumab or placebo via
intravenous infusion every 4 weeks. The primary endpoint is time to
meaningful progression on motor signs of the disease, as assessed
by ≥ 5 point increase from baseline in the Movement Disorder
Society – Unified Parkinson’s Disease Rating
Scale (MDS-UPDRS) Part III score.
For more information on the Phase 2b PADOVA
study, please visit clinicaltrials.gov and search NCT #
04777331.
About Parkinson's Disease
Parkinson's disease is a progressive
degenerative disorder of the entire nervous system that affects one
in 100 people over age 60. An estimated seven to 10 million people
are 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. There are currently no
treatments available that target the underlying cause of the
disease and can slow its progression.
About Alpha-synuclein
Alpha-synuclein, a protein found in neurons and
other cells, is a major component of the pathology that
characterizes several neurodegenerative disorders including
Parkinson's disease, dementia with Lewy bodies, and multiple system
atrophy, which collectively are termed synucleinopathies. The
understanding of the normal physiological function of
alpha-synuclein is limited, but evidence indicates that soluble
forms of the protein may interact with other proteins and certain
intracellular membranes. In synucleinopathies, the alpha-synuclein
protein appears to be abnormally aggregated intracellularly, which
contributes to disease pathology. There is increasing evidence that
certain aggregated forms of alpha-synuclein can be transmitted from
neuron to neuron, resulting in a propagation of pathology that
causes neuronal dysfunction and loss. Recent studies in cellular
and animal models of synucleinopathy suggest that the spread of
alpha-synuclein-associated neuronal pathology can be disrupted by
targeting aberrant forms of alpha-synuclein.
About Prasinezumab
Prasinezumab is a humanized monoclonal antibody
that targets a carboxyl terminal epitope of alpha-synuclein, a
protein found in neurons that can aggregate and spread from cell to
cell, resulting in the neuronal dysfunction and loss that causes
Parkinson’s disease. Prasinezumab is designed to block the
cell-to-cell transmission of the aggregated, pathogenic forms of
alpha-synuclein in Parkinson's disease, thereby slowing clinical
decline. Prior to initiating clinical trials, the efficacy of
prasinezumab was evaluated in various cellular and animal models of
alpha-synuclein-related disease. In alpha-synuclein transgenic
mice, the murine version of prasinezumab reduced the appearance of
alpha-synuclein pathology, protected synapses and halted the
worsening of behavioral phenotypes. In December
2013, Prothena and Roche entered into a worldwide
collaboration to develop and commercialize antibodies that target
alpha-synuclein, including prasinezumab. Prothena has an
option to co-promote prasinezumab 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 prasinezumab and
has agreed to pay Prothena up to double-digit royalties
on net sales. To date, Prothena has received $75
million and earned an additional $60 million of a total
potential $600 million in milestone payments that
includes clinical, regulatory and sales milestones. For more
information on the Phase 2 PASADENA clinical study of prasinezumab
in patients with early Parkinson's disease,
visit clinicaltrials.gov and search NCT #03100149.
About Prothena
Prothena Corporation plc is a late-stage
clinical company with a robust pipeline of novel investigational
therapeutics built on protein dysregulation expertise with the
potential to change the course of devastating rare peripheral
amyloid and neurodegenerative diseases. Fueled by its deep
scientific expertise built over decades of research, Prothena is
advancing a pipeline of therapeutic candidates for a number of
indications and novel targets for which its ability to integrate
scientific insights around neurological dysfunction and the biology
of misfolded proteins can be leveraged. Prothena’s pipeline
includes both wholly-owned and partnered programs being developed
for the potential treatment of diseases including AL amyloidosis,
ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a
number of other neurodegenerative diseases. For more information,
please visit the Company’s website at www.prothena.com and follow
the Company on Twitter @ProthenaCorp.
Forward-looking Statements
This press release contains forward-looking
statements. These statements relate to, among other things, the
treatment potential, design, and proposed mechanism of action of
prasinezumab; plans for the Phase 2b PADOVA clinical study of
prasinezumab; and amounts we might receive 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 effects on our business of the worldwide
COVID-19 pandemic and the risks, uncertainties and other factors
described in the “Risk Factors” sections of our Prospectus
Supplement filed pursuant to Rule 424(b)5 with the Securities and
Exchange Commission (SEC) on March 24, 2021, as well as discussions
of potential risks, uncertainties, and other important factors in
our subsequent filings with the SEC. We undertake 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 our expectations.
Contact:
Jennifer Zibuda, Director, Investor Relations
& Communications650-837-8535,
jennifer.zibuda@prothena.com
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