Conference Call and Webcast at 8:00 AM Eastern
Time on Friday, May 8
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 a reprioritization
of its product development programs. As a result of this
reprioritization, La Jolla will discontinue development of its
polysaccharide-based galectin-3 inhibitors, GCS-100 and LJPC-1010.
The reprioritization will allow La Jolla to reallocate resources to
its other development candidates, including its lead product
candidate LJPC-501, La Jolla’s proprietary formulation of
angiotensin II that is currently the subject of a Phase 3
registration clinical trial in patients suffering from
catecholamine-resistant hypotension, LJPC-401, La Jolla’s novel
formulation of hepcidin for the potential treatment of conditions
characterized by iron overload, and LJPC-30Sa and LJPC-30Sb, La
Jolla’s recently announced next-generation gentamicin derivative
product candidates for the potential treatment of serious bacterial
infections and rare genetic disorders.
The portfolio reprioritization is the result of both the
addition of the next-generation gentamicin derivative program and a
recent interaction with the U.S. Food and Drug Administration (FDA)
regarding La Jolla’s galectin-3 inhibitor program. In this
interaction, the FDA indicated that the Company would be required
to conduct additional chemical characterization of GCS-100 prior to
further clinical development. GCS-100 and LJPC-1010 are complex
polysaccharide mixtures that cannot be readily chemically
characterized using conventional analytical methods, and the
Company believes that the timeframe and ultimate success of
developing analytical methods that would satisfy the FDA’s
requirements are highly uncertain. There were no issues raised by
the FDA related to patient safety or preclinical toxicology.
The Company will continue to treat and follow patients already
enrolled in its Phase 2b study in diabetic patients with advanced
chronic kidney disease, but will stop enrolling new patients. The
Company will not proceed with a Phase 1 study of LJPC-1010 as
previously planned. La Jolla will instead explore out-licensing
opportunities for these product candidates.
“We are very enthusiastic about LJPC-501 and LJPC-401 and the
unmet medical needs that they may fulfill, and we are excited to
add our new next-generation gentamicin derivative program to our
portfolio. These product candidates all benefit from strong
scientific and clinical rationale, and today’s reprioritization
will allow us to sharpen our focus on bringing them closer to
patients,” stated George F. Tidmarsh, M.D., Ph.D., President and
Chief Executive Officer of La Jolla. “While it was a difficult
decision to discontinue our galectin-3 inhibitor programs, we
believe that this is the right decision for the Company and its
stakeholders as we evaluate our portfolio opportunities and how
best to allocate our resources. This reprioritization will free up
significant financial resources, and we continue to project that
our current cash resources will be sufficient to fund our
operations, including the advancement of all three of these
programs, through the end of 2016.”
Conference Call and Webcast
The Company will hold an investor conference call and webcast at
8:00 AM Eastern Time/5:00 AM Pacific Time on Friday, May 8, 2015.
You can participate on the call by either dialing 877-359-9508 pin:
44727023 or click here for the webcast.
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,
which was recently published in the journal Critical Care, as well
as in animal models of hypotension. Preclinical pharmacology
studies conducted by La Jolla have demonstrated that catecholamine
resistance may be in part a result of reduced endogenous production
of angiotensin II. 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. The ATHOS 3 trial is being
conducted under a Special Protocol Assessment with the U.S. Food
and Drug Administration in which it was agreed that the primary
efficacy endpoint is increase in blood pressure. Results from ATHOS
3 are expected by the end of 2016.
About LJPC-401
LJPC-401 is La Jolla’s novel formulation of hepcidin. Hepcidin
is a naturally occurring peptide hormone that controls and
regulates iron metabolism. By suppressing iron release and
absorption, hepcidin prevents iron accumulation in tissues, such as
the liver, heart and pancreas, where it can cause significant
damage and even result in death. La Jolla is developing LJPC-401
for the treatment of conditions characterized by iron overload,
such as hemochromatosis and beta thalassemia. Preclinical studies
have shown that the administration of LJPC-401 results in reduced
serum iron in all animal species tested. Animal toxicology studies
have established the proposed doses for LJPC-401’s Phase 1 clinical
trial, and these doses have translated into animal exposures that
have shown to lower serum iron levels in all animal species tested.
La Jolla expects to file an Investigational New Drug application
(IND) with the U.S. Food and Drug Administration in mid-2015.
LJPC-401 has been successfully manufactured under Good
Manufacturing Practice (GMP) for use in La Jolla’s single,
ascending-dose Phase 1 clinical trial, which is expected to
commence in the second half of 2015. This proposed Phase 1 clinical
trial will evaluate the effects of LJPC-401 on serum iron
parameters, as well as safety and pharmacodynamics, in healthy
volunteers, with results expected by the end of 2015.
About LJPC-30Sa and LJPC-30Sb
LJPC-30Sa and LJPC-30Sb are La Jolla’s next-generation
gentamicin derivatives. Despite kidney toxicity, gentamicin has
become one of the most commonly prescribed hospital antibiotics.
Gentamicin consists primarily of a mixture of four distinct but
closely related chemical entities that may contribute
differentially to the product’s toxicity profile. Gentamicin’s
ability to induce a lack of fidelity in gene transcription,
intrinsic to its antimicrobial mechanism of action, can also be
leveraged in the correction of certain human genetic mutations that
lead to rare genetic disorders, such as cystic fibrosis and
Duchenne muscular dystrophy. In spite of favorable short-term
clinical proof-of-efficacy data in cystic fibrosis, development of
gentamicin as a chronic treatment for these genetic diseases has
been limited by its toxicity profile. LJPC-30Sa and LJPC-30Sb are
purified components of the currently marketed gentamicin product
that retain the biologic activity of gentamicin, yet appear to lack
the traditional kidney toxicity associated with it. La Jolla is
developing LJPC-30Sa and LJPC-30Sb for the potential treatment of
serious bacterial infections and rare genetic disorders, such as
cystic fibrosis and Duchenne muscular dystrophy. Following a
pre-Investigational New Drug application (IND) meeting with the
U.S. Food and Drug Administration, La Jolla has received guidance
that it may proceed with its proposed Phase 1 clinical trial
following the submission of an IND.
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 angiotensin II for the potential
treatment of catecholamine-resistant hypotension and hepatorenal
syndrome. 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. LJPC-30Sa
and LJPC-30Sb are La Jolla’s next-generation gentamicin derivatives
for the potential treatment of serious bacterial infections and
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 document 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 and
involve known and unknown risks, uncertainties and other factors,
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 timing for the filing of an
Investigational New Drug Application, commencement of clinical
studies and the anticipated timing for completion of such studies;
the success of future development activities for LJPC-501,
LJPC-401, LJPC-30Sa and LJPC-30Sb; potential indications for which
LJPC-501, LJPC-401, LJPC-30Sa and LJPC-30Sb may be developed; and
any future success in out-licensing or partnering GCS-100 or
LJPC-1010. 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.,
858-207-4264President & Chief Executive
Officergtidmarsh@ljpc.comorDennis M. Mulroy, 858-433-6839Chief
Financial Officerdmulroy@ljpc.com
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