Prothena Outlines Phase 2 Development Strategy for PRX003
(Thomson Reuters ONE) -
* Investor conference call and webcast planned today at 4:30 PM ET
DUBLIN, Ireland, Sept. 29, 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,
will host a conference call and webcast today at 4:30 PM Eastern Time to discuss
its Phase 2 clinical development strategy in psoriatic arthritis for PRX003, an
antibody that targets the cellular adhesion molecule CD146, which is expressed
on the surface of Th17 cells.
"We are excited to highlight development plans for PRX003, an antibody designed
to block pro-inflammatory Th17 cells from infiltrating into tissue and releasing
multiple cytokines that contribute to inflammatory disease pathology," stated
Gene Kinney, PhD, Prothena's Chief Operating Officer. "Based on the biology of
psoriatic arthritis and the novel proposed mechanism of PRX003, we believe this
approach has the potential to offer an improved therapeutic option for patients
suffering from this disease."
Pro-inflammatory Th17 Cells and PRX003 Potential Mechanisms of Action
Pro-inflammatory Th17 cells release multiple cytokines that contribute to
inflammatory disease pathology, including IL-17, TNF-alpha, IL-6, IFNgamma, IL-
22, and CCL20 (Liuzzo, et. al., European Heart Journal, 2013; Mohan et. al.,
American Journal of Pathology, July 2012).
PRX003 was designed to target CD146, a cell adhesion molecule also known as
melanoma cell adhesion molecule (MCAM), which is expressed on the surface of
Th17 cells. CD146 facilitates Th17 cell migration from circulation into tissue,
a necessary step required to initiate and/or perpetuate an inflammatory disease
process. Prothena discovered that laminin alpha4 is the endothelial binding
partner for CD146, and this binding is necessary to facilitate the migration of
Th17 cells from circulation into tissue.
PRX003 is designed to occupy CD146, leading to downregulation which sequesters
pro-inflammatory Th17 cells in the bloodstream, preventing their migration into
tissue. PRX003 may also induce the demargination of Th17 cells that are already
adherent to blood vessels or tissue.
Planned PRX003 Phase 2 Development Strategy
Prothena plans to advance a Phase 2 clinical study of PRX003 for the treatment
of psoriatic arthritis, a Th17-mediated disease where multiple cytokines
contribute to pathology.
Psoriatic arthritis is a potentially debilitating disease characterized by pain,
stiffness and swelling in the joints and surrounding ligaments and tendons.
According to the National Psoriais Foundation, as many as 45 percent of patients
with psoriatic arthritis are dissatisfied with their current treatment
(Armstrong AW, et. al., JAMA, 2013). There is an unmet need for more effective
and tolerable therapies in this patient population.
In patients with psoriatic arthritis, there are significantly more CD146
expressing T cells at the site of inflammation than in the peripheral blood,
suggesting a role for CD146 - expressed on the surface of Th17 cells - in the
migration of pathogenic cells into joints (Raychaudhuri, et. al., poster
presentation at 2105 ACR/ARHP Annual Meeting, abstract #982). Due to its
proposed upstream mechanism of action, PRX003 is expected to block the release
of multiple Th17 related cytokines that are known to contribute to psoriatic
arthritis pathology including IL-17, TNF-alpha, IL-6, IFNgamma, IL-22, and
CCL20.
Prothena is conducting a Phase 1b double-blind, placebo controlled, multiple
ascending dose, proof-of-biology study in approximately 56 patients with
psoriasis. This study is evaluating safety, tolerability, pharmacokinetics,
immunogenicity, and pharmacodynamics, and will also evaluate the Psoriasis Area
and Severity Index (PASI) following treatment with PRX003 as a means to assess
proof-of-biology.
Should the interim analysis of the ongoing Phase 1b multiple ascending dose
proof-of-biology study in patients with psoriasis meet certain pre-specified
criteria, Prothena will begin preparation for a Phase 2 study in patients with
psoriatic arthritis. The interim analysis is expected by mid-2017.
Conference Call and Webcast Details
Prothena will host a webcast today at 4:30 PM Eastern Time to discuss its plans
for Phase 2 development of PRX003. 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
83102616. A replay of the webcast and call will be available for at least 90
days via dial-in at (855) 859-2056 (U.S. toll free) or (404) 537-3406
(international), Conference ID Number 83102616.
About PRX003
PRX003 is a monoclonal antibody being developed for the potential treatment of
Th17-mediated inflammatory diseases where multiple cytokines contribute to
pathology. PRX003 is designed to occupy and downregulate CD146, also known as
melanoma cell adhesion molecule (MCAM), a cell adhesion molecule expressed on
the surface of Th17 cells, sequestering cells that secrete disease-causing
cytokines in the bloodstream and preventing their migration into tissues. As
CD146-expressing Th17 cells appear to be disproportionately involved in
propagation of inflammation, targeting the T cell, rather than any individual
cytokine, may provide a highly specific way to impact multiple pathogenic
processes, while leaving the vast majority of immune cells intact. In a
randomized, double-blind, placebo-controlled, single ascending dose Phase 1
clinical study in healthy volunteers, PRX003 was found to be safe and well
tolerated, and demonstrated greater than 95 percent neutralization of CD146 at
saturating drug exposures. Prothena's plans for a Phase 2 study of PRX003 in
psoriatic arthritis will be based on certain pre-specified criteria being met in
an interim analysis of an ongoing Phase 1b proof-of-biology study in patients
with psoriasis. For more information about Prothena's ongoing proof-of-biology
Phase 1b clinical study of PRX003 in patients with psoriasis please
visit www.clinicaltrials.govand search identifier NCT02630901.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic and progressive inflammatory autoimmune disease
characterized by pain, stiffness and swelling in the joints and surrounding
ligaments and tendons. Psoriatic arthritis impacts as many as 1 million people
in the US, EU5, and Japan (Psoriatic Arthritis Disease Coverage - 2013
Datamonitor report). According to the National Psoriasis Foundation, nearly one
in four people with psoriasis may have undiagnosed psoriatic arthritis.
Psoriatic arthritis can be disabling and cause irreversible joint damage if left
untreated.
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, the potential of PRX003 to offer an improved therapeutic
option for patients suffering from psoriatic arthritis; the design and proposed
mechanisms of action of PRX003; whether PRX003 blocks infiltration of Th17 cells
into tissue and sequesters them in the circulation, and induces demargination of
Th17 cells; the potential for our Phase 1b study of PRX003 to provide proof-of-
biology; the timing of announcing interim results of the Phase 1b study of
PRX003; and our contemplated Phase 2 development strategy and clinical study of
PRX003 in psoriatic arthritis. 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: 29.09.2016 - 22:05 Uhr
Sprache: Deutsch
News-ID 498018
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contact information:
Town:
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