La Jolla Pharmaceutical Company Announces Initiation of Phase 3 Clinical Trial of LJPC-501 in Catecholamine-Resistant Hypoten...
March 24 2015 - 8:00AM
Business Wire
La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the Company or
La Jolla), a leader in the development of innovative therapies
intended to significantly improve outcomes in patients suffering
from life-threatening diseases, today announced that it has
initiated its ATHOS (Angiotensin II for the Treatment of High-Output Shock) 3 trial, a Phase 3 clinical trial of
LJPC-501 for the treatment of catecholamine-resistant hypotension
(CRH). In February 2015, La Jolla reached agreement with the U.S.
Food and Drug Administration (FDA) on a Special Protocol Assessment
(SPA), in which it was agreed that the primary efficacy endpoint
for the trial would be increase in blood pressure. CRH is an acute,
life-threatening condition in which blood pressure drops to
dangerously low levels in patients who respond poorly to current
treatments.
In accordance with the SPA, the ATHOS 3 trial is a multicenter,
randomized, double-blind, placebo-controlled, Phase 3 clinical
trial of LJPC-501 in patients with CRH. The ATHOS 3 trial is
designed to enroll approximately 315 patients. Patients will be
randomized 1:1 to receive either LJPC-501 plus standard-of-care
vasopressors or placebo plus standard-of-care vasopressors.
Randomized patients will receive their assigned treatment via
continuous IV infusion for up to 7 days.
The primary efficacy endpoint of the ATHOS 3 trial is to compare
the change in mean arterial pressure between the two groups in the
trial. Secondary endpoints include comparison of changes in
Sequential Organ Failure Assessment scores and the safety and
tolerability of LJPC-501 in patients with CRH. La Jolla has reached
agreement with the FDA that an adequately sized Phase 3 trial
comprised of 200-300 patients would provide a sufficient safety
database to support FDA review and consideration for marketing
approval.
“The prognosis for patients suffering from CRH is very poor, and
current treatment options are limited. We believe that LJPC-501 has
the potential to reverse hypotension and, therefore, provide a
significant benefit to these difficult-to-treat patients,” said
Lakhmir Chawla, M.D., Associate Professor of Medicine, Department
of Anesthesiology and Critical Care Medicine, George Washington
University.
“We are pleased to have advanced LJPC-501 into a Phase 3
registration clinical trial,” said George F. Tidmarsh, M.D., Ph.D.,
President and Chief Executive Officer of La Jolla. “We would like
to thank the FDA and our clinical collaborators for helping us to
advance this medically important program so expeditiously.”
About LJPC-501
LJPC-501 is La Jolla’s proprietary formulation of 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. La Jolla is developing LJPC-501 for
the treatment of catecholamine-resistant hypotension (CRH), which
is an acute, life-threatening condition in which blood pressure
drops to dangerously low levels in patients who respond poorly to
current treatments. Angiotensin II has been shown to raise blood
pressure in a randomized, placebo-controlled clinical trial in CRH,
as well as animal models of hypotension. In October 2014, La Jolla
presented positive data from a preclinical study of LJPC-501 for
the treatment of CRH. La Jolla is currently enrolling patients into
its ATHOS (Angiotensin II for the
Treatment of High-Output
Shock) 3 trial, which is a
multicenter, randomized, double-blind, placebo-controlled, Phase 3
clinical trial of LJPC-501 in patients with CRH.
La Jolla is also developing LJPC-501 for hepatorenal syndrome
(HRS). HRS is a life-threatening form of progressive renal failure
in patients with liver cirrhosis or fulminant liver failure. In
these patients, the diseased liver secretes vasodilator substances
(e.g., nitric oxide and prostaglandins) into the bloodstream that
cause under-filling of blood vessels. This low blood pressure state
causes a reduction in blood flow to the kidneys. As a means to
restore systemic blood pressure, the kidneys induce both sodium and
water retention, which contribute to ascites, a major complication
associated with HRS. Studies have shown that LJPC-501 may improve
renal function in patients with conditions similar to HRS. La Jolla
is currently enrolling patients into a Phase 1/2 clinical trial of
LJPC-501 in HRS.
About Special Protocol Assessments
A Special Protocol Assessment is a written agreement between a
sponsor and the U.S. Food and Drug Administration on the design,
execution and analysis for a clinical trial that may form the basis
of a new drug application (NDA). Final marketing approval depends
upon the efficacy results, the safety profile and an evaluation of
the risk/benefit of treatment demonstrated in the Phase 3 clinical
program.
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
four product candidates in development. LJPC-501 is La Jolla’s
proprietary formulation of angiotensin II for the potential
treatment of catecholamine-resistant hypotension and hepatorenal
syndrome. GCS-100 is La Jolla’s first-in-class galectin-3 inhibitor
for the potential treatment of chronic kidney disease. LJPC-1010,
La Jolla’s second-generation galectin-3 inhibitor, is a more potent
and purified derivative of GCS-100 that can be delivered orally for
the potential treatment of nonalcoholic steatohepatitis and other
diseases characterized by tissue fibrosis. LJPC-401 is La Jolla’s
novel formulation of hepcidin for the potential treatment of
conditions characterized by iron overload, such as hemochromatosis
and beta thalassemia. For more information on La Jolla, please
visit www.ljpc.com.
Forward-Looking Statement Safe Harbor
This document contains “forward-looking statements,” as that
term is defined in the Private Securities Litigation Reform Act of
1995. These statements relate to the Company’s expectations
regarding future events or its future results of operations. These
statements are only predictions and involve known and unknown
risks, uncertainties and other factors, any one of which may cause
actual results to be materially different from these
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 http://www.sec.gov. These risks include, but
are not limited to, risks relating to the future development of
LJPC-501 for the treatment of CRH and the success of future
development activities for this and other drug development programs
sponsored by the Company and potential indications for which these
drug candidates may be developed. Subsequent written and oral
forward-looking statements attributable to the Company or to
persons acting on its behalf are expressly qualified in their
entirety by the cautionary statements set forth in the Company’s
reports filed with the SEC. The Company expressly disclaims any
intent to update any forward-looking statements.
La Jolla Pharmaceutical CompanyGeorge F. Tidmarsh, M.D.,
Ph.D.President & Chief Executive Officer(858)
207-4264gtidmarsh@ljpc.comorChester S. Zygmont, IIISenior Director
of Finance(858) 207-4262czygmont@ljpc.com
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