La Jolla Pharmaceutical Company Announces Initiation of Phase 2b Clinical Trial of GCS-100 in Advanced Chronic Kidney Disease
March 18 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 Phase 2b clinical trial of GCS-100 for the treatment
of advanced chronic kidney disease (CKD) caused by diabetes. CKD is
a condition characterized by a gradual loss of kidney function over
time that may eventually lead to kidney failure, requiring dialysis
or a kidney transplant to maintain life.
The Phase 2b clinical trial is a double-blind, multi-center,
placebo-controlled, randomized trial of GCS-100 in diabetic
patients with Stage 3b or 4 CKD. The clinical trial is designed to
enroll approximately 375 patients. Patients will be randomized
1:1:1:1 to receive fixed doses of GCS-100 (1, 3 or 9 mg) or
placebo. Randomized patients will receive their assigned treatment
via IV injection once a week for 8 weeks and then once every other
week for an additional 16 weeks.
The primary endpoint of this Phase 2b clinical trial is to
compare the change in kidney function, as measured by estimated
glomerular filtration rate (eGFR), from baseline to week 26, which
is 2 weeks after the last injection, between patients receiving
GCS-100 or placebo. Secondary efficacy endpoints include a
responder analysis based on pre-specified percentage changes in
eGFR and an analysis on progression to renal replacement therapy.
Other secondary endpoints are focused on the long-term safety and
tolerability of GCS-100, including an evaluation of the incidence
of major cardiac events.
“Chronic kidney disease is an enormous and growing medical
problem worldwide. A disease-modifying agent that could slow and
potentially reverse the tissue fibrosis that is a hallmark of this
disease would be a welcome advance in the field and could have a
major impact on patients’ lives,” stated the trial’s principal
investigator, Pablo E. Pergola, M.D., Ph.D., Director of the
Clinical Advancement Center subsidiary of Renal Associates P.A. and
Clinical Associate Professor of Medicine at the University of Texas
Health Science Center at San Antonio. “Our experience with GCS-100
in previous trials was very encouraging, and my patients tolerated
the therapy well.”
“We are excited to be advancing GCS-100 into the next phase of
development,” said George F. Tidmarsh, M.D., Ph.D., President and
Chief Executive Officer of La Jolla. “This Phase 2b trial will
build on the knowledge we gained from our recently completed Phase
2 trial, in which treatment with GCS-100 resulted in a
statistically significant improvement in kidney function.”
About GCS-100
GCS-100, La Jolla’s first-in-class galectin-3 inhibitor, is a
complex polysaccharide derived from pectin that binds to, and
blocks the activity of, the pro-fibrotic mediator galectin-3.
Over-expression of galectin-3 has been implicated in a number of
human diseases characterized by progressive tissue fibrosis, such
as chronic kidney disease (CKD). La Jolla recently completed a
multicenter, randomized, placebo-controlled, Phase 2 clinical trial
in advanced CKD patients, in which treatment with GCS-100 resulted
in a statistically significant improvement in kidney function
compared to placebo.
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
GCS-100 for the treatment of advanced CKD 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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