Results of ATHOS-3 Phase 3 Study of LJPC-501 Published in The New England Journal of Medicine
May 21 2017 - 1:10PM
Business Wire
La Jolla Pharmaceutical Company (Nasdaq: LJPC) (La Jolla) today
announced that results of the ATHOS-3 (Angiotensin II for the Treatment of High-Output
Shock) Phase 3 study of LJPC-501
(angiotensin II) have been published online by The New England
Journal of Medicine (NEJM). The article, entitled “Angiotensin II
for the Treatment of Vasodilatory Shock,” also will be published in
the May 25, 2017 print issue of NEJM.
“There is a major need for new treatment options for critically
ill patients who do not adequately respond to available
vasopressors,” stated Rinaldo Bellomo, M.D., Professor of Intensive
Care Medicine at University of Melbourne and Director of Intensive
Care Research at Austin Health. “In ATHOS-3, angiotensin II was
shown to raise blood pressure with no increase in overall adverse
events as compared to placebo in this highly treatment-resistant
patient population. The effect of angiotensin II resulted in
reduced use of other vasopressors. If approved, angiotensin II, in
combination with other vasopressors, may allow clinicians to
leverage all three major physiologic systems that regulate blood
pressure.”
The analysis of the primary efficacy endpoint of ATHOS-3,
defined as the percentage of patients achieving a mean arterial
pressure (MAP) ≥ 75 mmHg or a 10 mmHg increase from baseline MAP at
3 hours following the initiation of study treatment without an
increase in standard-of-care vasopressors, was statistically
significant: 23.4% of the 158 placebo-treated patients achieved the
pre-specified blood pressure response, compared to 69.9% of the 163
angiotensin II-treated patients (p<0.001). In addition, a trend
toward longer survival was observed for angiotensin II-treated
patients (22% reduction in mortality risk through day 28; hazard
ratio=0.78 [CI: 0.57, 1.07; p=0.12]). In this critically ill
patient population, 91.8% of placebo-treated patients experienced
at least one adverse event, compared to 87.1% of angiotensin
II-treated patients, and 21.5% of placebo-treated patients
discontinued treatment due to an adverse event, compared to 14.1%
of angiotensin II-treated patients.
The NEJM article can be found here and its Supplementary
Appendix can be found here.
About the ATHOS-3 Study
The ATHOS-3 study was a multicenter, randomized, double-blind,
placebo-controlled, Phase 3 clinical study of LJPC-501 in patients
with catecholamine resistant hypotension (CRH), which is a severe
form of vasodilatory shock. A total of 344 patients were randomized
across nine countries, 321 of whom received study treatment and are
included in the primary analysis. Patients were randomized 1:1 to
receive either LJPC-501 or placebo on a background of
standard-of-care vasopressors selected by the investigators.
Randomized patients received their assigned treatment via
continuous intravenous infusion.
The primary efficacy endpoint was the percentage of patients
achieving a mean arterial pressure (MAP) ≥ 75 mmHg or a 10 mmHg
increase from baseline MAP at 3 hours following the initiation of
study treatment without an increase in standard-of-care
vasopressors. The study was conducted under a Special Protocol
Assessment (SPA) agreed to with the U.S. Food and Drug
Administration (FDA) in 2015. The SPA stipulates that a study of
this size and design could provide sufficient safety and efficacy
data and an adequate evaluation of the risk/benefit to the patients
to support FDA review and consideration for marketing approval. La
Jolla reported positive top-line results in February 2017.
About LJPC-501
LJPC-501 is La Jolla’s proprietary formulation of synthetic
human angiotensin II. Angiotensin II, the major bioactive component
of the renin-angiotensin system, serves as one of the body’s
central regulators of blood pressure. LJPC-501 is being developed
for the treatment of patients with CRH. LJPC-501 is the first
synthetic human angiotensin II product candidate to be tested in a
Phase 3 study.
About Catecholamine Resistant Hypotension
Catecholamine resistant hypotension (CRH) is a life-threatening
syndrome in patients with vasodilatory (also known as distributive)
shock (dangerously low blood pressure with adequate cardiac
function) who cannot achieve target mean arterial pressure (MAP)
despite adequate fluid resuscitation and treatment with currently
available vasopressors (catecholamines and/or vasopressin). There
are approximately 500,000 distributive shock cases in the United
States per year, an estimated 200,000 of which develop CRH. More
than 50% of CRH 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
potential treatment of catecholamine resistant hypotension.
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 of the planned NDA
submission for LJPC-501 and prospects for approval of LJPC-501 by
the FDA and the other regulatory authorities; risks relating to the
scope of product labels (if approved) and potential market sizes,
as well as the broader commercial opportunity; the anticipated
timing for regulatory actions; and the success of future
development activities; potential indications for which the
company’s product candidates may be developed. The company
expressly disclaims any intent to update any forward-looking
statements to reflect the outcome of the consequent events.
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La Jolla Pharmaceutical CompanySandra Vedrick,
858-256-7910Associate Director, Investor Relations & Human
Resourcessvedrick@ljpc.comandDennis M. Mulroy, 858-433-6839Chief
Financial Officerdmulroy@ljpc.comorMediaLifeSci Public
RelationsMatt Middleman, M.D.,
646-627-8384matt.middleman@lifescipublicrelations.com
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