La Jolla Pharmaceutical Company Announces Special Protocol Assessment for Planned Phase 3 Trial of LJPC-501 in Catecholamine-...
February 09 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 reached
agreement with the U.S. Food and Drug Administration (FDA) on a
Special Protocol Assesment (SPA) for its Phase 3 clinical trial of
LJPC-501 for the treatment of catecholamine-resistant hypotension
(CRH). In accordance with the SPA, the primary efficacy endpoint
for this Phase 3 registration trial will be increase in blood
pressure. La Jolla plans to initiate this multicenter, randomized,
double-blind, placebo-controlled, Phase 3 clinical trial pursuant
to the approved SPA in the first quarter of 2015.
“We are very pleased with the FDA’s agreement on our clinical
trial design and planned analysis, which clearly defines what we
believe to be a feasible path for the development and registration
of LJPC-501,” said George F. Tidmarsh, M.D., Ph.D., President and
Chief Executive Officer of La Jolla. “The prognosis for patients
suffering from CRH is very poor, with less than 50% of these
patients surviving one month from diagnosis. We believe that
LJPC-501 has the potential to reverse hypotension and, therefore,
provide a significant benefit to these patients.”
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, or 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 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, or CRH, which
is an acute, life-threatening condition in which blood pressure
drops to dangerously low levels and is poorly responsive 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. In February 2015, La Jolla reached agreement
with the FDA on a Special Protocol Assessment, or SPA, for its
Phase 3 clinical trial of LJPC-501 for the treatment of CRH, in
which agreement was reached that blood pressure can be the primary
endpoint for approval. La Jolla’s Phase 3 clinical trial of
LJPC-501 for the treatment of CRH is expected to begin in the first
quarter of 2015. La Jolla has submitted an Orphan Drug Designation
application to the FDA for LJPC-501 for the treatment of CRH.
La Jolla is also developing LJPC-501 for hepatorenal syndrome,
or 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 conducting a Phase 1/2 clinical trial of LJPC-501 in
HRS. The Phase 1/2 clinical trial is currently enrolling
patients.
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 iron
overload. 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; the ability of the Company to obtain
orphan drug status for LJPC-501; the ability of the Company to use
the planned Phase 3 study of LJPC-501 in CRH as a registration
study; and the success of other potential indications for which
this and other 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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