Prespecified Analysis of ATHOS-3 Indicates Survival Benefit in LJPC-501-Treated Patients with Relatively Low Angiotensin II S...
September 20 2017 - 4:50PM
Business Wire
Analysis to Be Presented in Oral Session at the
30th Annual Congress of The European Society of Intensive Care
Medicine
La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or
La Jolla) today announced an abstract entitled "Baseline
angiotensin levels and ACE effects in patients with vasodilatory
shock treated with angiotensin II" has been selected for
presentation at the upcoming 30th European Society of Intensive
Care Medicine (ESICM) LIVES Annual Congress being held September 23
to 27, 2017 in Vienna, Austria.
The abstract published online today includes results from a
pre-specified analysis of the ATHOS-3 (Angiotensin II for the
Treatment of High Output Shock) multicenter, randomized,
double-blind, placebo-controlled, Phase 3 clinical study of
LJPC-501 (synthetic human angiotensin II) in patients with
distributive or vasodilatory shock who remain hypotensive despite
fluid and vasopressor therapy. The authors present data showing
that a relatively low angiotensin II state (as measured by the
ratio of angiotensin I to angiotensin II) predicted increased
mortality in patients with vasodilatory shock, suggesting that the
activity of angiotensin converting enzyme (ACE), which converts
angiotensin I to angiotensin II, may play a critical physiologic
role in patients with vasodilatory shock. Furthermore, there was a
statistically significant treatment effect of LJPC-501 compared to
placebo on mortality in these patients with a relatively low
angiotensin II state (relative risk reduction of 36%; HR=0.64; 95%
CI: 0.41-1.00; p=0.047).
These results will be reviewed by Marlies Ostermann, M.D.,Ph.D.,
of Guy's and St. Thomas’ Hospital, London, on Tuesday, September
26, 2017.
30th European Society of Intensive Care
Medicine Annual Congress Presentation Details
Poster Number:
0703
Presentation Title:
Baseline angiotensin levels and ACE effects in patients with
vasodilatory shock treated with angiotensin II
Presenter:
Marlies Ostermann, M.D.,Ph.D., of Guy's and St. Thomas’ Hospital,
London
Session Date:
Tuesday, September 26, 2017
Session Time:
16:00 - 17:50
Session Room:
Area Graz
About LJPC-501
LJPC-501 is La Jolla’s proprietary formulation of synthetic
human angiotensin II. Angiotensin II is the major bioactive
component of the renin-angiotensin-aldosterone system (RAAS). The
RAAS is one of three central regulators of blood pressure. LJPC-501
is a first in class vasopressor that leverages RAAS. LJPC-501 is
being developed for the treatment of patients with distributive or
vasodilatory shock who remain hypotensive despite fluid and
vasopressor therapy (catecholamines and/or vasopressin).
In August 2017, the Company announced that its New Drug
Application (NDA) for LJPC-501 had been accepted for review by the
U.S. Food and Drug Administration (FDA). The review
classification for the application is Priority, and the user fee
goal date under the Prescription Drug User Fee Act (PDUFA) is
February 28, 2018. The NDA is based on results of the ATHOS-3
(Angiotensin II for the Treatment of High Output Shock)
multicenter, randomized, double-blind, placebo-controlled, Phase 3
clinical study of LJPC-501 in patients with distributive or
vasodilatory shock who remain hypotensive despite fluid and
vasopressor therapy. The study was conducted under a Special
Protocol Assessment (SPA) agreed to with the FDA in 2015. A total
of 344 patients were randomized across nine countries, 321 of whom
received study treatment and were included in the primary analysis.
In May 2017 the results of the ATHOS-3 study were published
by The New England Journal of Medicine in an article
entitled “Angiotensin II for the Treatment of Vasodilatory
Shock”.
About Patients with Distributive or Vasodilatory Shock
Failing Standard Therapy
Distributive or vasodilatory shock (dangerously low blood
pressure with adequate cardiac function) can become
life-threatening when a patient is unable to achieve or maintain
target mean arterial pressure (MAP) despite treatment with the
currently available standard of care (fluids and vasopressors).
This life-threatening syndrome has been described as clinically
refractory hypotension, catecholamine resistant hypotension,
high-dose vasopressor-dependent shock, catecholamine or vasopressor
refractory shock, or catecholamine-resistant vasodilatory shock.
There are approximately 500,000 distributive or vasodilatory shock
patients in the United States per year with an estimated 200,000
patients failing standard therapy. Approximately 50% of these
patients die within 30 days.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company
focused on the discovery, development and commercialization of
innovative therapies intended to significantly improve outcomes in
patients suffering from life-threatening diseases. The Company has
several product candidates in development. LJPC-501 is La Jolla’s
proprietary formulation of synthetic human angiotensin II for the
treatment of hypotension in adult patients with distributive or
vasodilatory shock who remain hypotensive despite fluid and
vasopressor therapy. LJPC-401 is La Jolla’s proprietary formulation
of synthetic human hepcidin for the potential treatment of
conditions characterized by iron overload, such as hereditary
hemochromatosis, beta thalassemia, sickle cell disease and
myelodysplastic syndrome. LJPC-30S is La Jolla’s next-generation
gentamicin derivative program that is focused on the potential
treatment of serious bacterial infections as well as rare genetic
disorders, such as cystic fibrosis and Duchenne muscular dystrophy.
For more information on La Jolla, please visit www.ljpc.com.
Forward Looking Statement Safe Harbor
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995. These statements relate to future events or the Company’s
future results of operations. These statements are only predictions
or statements of current expectations and involve known and unknown
risks, uncertainties and other factors, that may cause actual
results to be materially different from those anticipated by the
forward-looking statements. The Company cautions readers not to
place undue reliance on any such forward-looking statements, which
speak only as of the date they were made. Certain of these risks,
uncertainties, and other factors are described in greater detail in
the Company’s filings with the U.S. Securities and Exchange
Commission (SEC), all of which are available free of charge on the
SEC’s web site www.sec.gov. These risks include, but are not
limited to, risks relating to: the timing and prospects for
approval of LJPC-501 by the FDA and other regulatory authorities;
risks relating to the scope of product labels (if approved);
potential market sizes; the anticipated timing for regulatory
actions; the impact of pharmaceutical industry regulation and
health care legislation in the United States; and the success
of future development activities. The Company expressly disclaims
any intent to update any forward-looking statements to reflect the
outcome of subsequent events.
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version on businesswire.com: http://www.businesswire.com/news/home/20170920006329/en/
Company ContactsLa Jolla Pharmaceutical CompanySandra
VedrickAssociate Director, Investor Relations & Human
Resources858-256-7910svedrick@ljpc.comandLa Jolla Pharmaceutical
CompanyDennis M. MulroyChief Financial
Officer858-433-6839dmulroy@ljpc.comorMedia ContactLifeSci
Public RelationsMatt Middleman,
M.D.646-627-8384matt.middleman@lifescipublicrelations.com
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