– Initiation of Phase 2 clinical trial expected
in Q2 2019 – – IBAT inhibition has potential to impact key
markers of NASH –
Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan
pediatric liver disease company developing novel bile acid
modulators, today announced that its Investigational New Drug
application (IND) has cleared the required 30 day review by the
U.S. Food and Drug Administration and is in effect for a Phase 2
clinical trial of elobixibat, a first-in-class, once-daily,
orally-available ileal bile acid transporter (IBAT) inhibitor, for
the treatment of nonalcoholic fatty liver disease (NAFLD) and
nonalcoholic steatohepatitis (NASH).
“The IND and subsequent trial initiation are an important step for
our NASH program, as we apply our expertise in bile acids and
leverage our novel IBAT platform to address a large unmet medical
need,” said Ron Cooper, President and Chief Executive Officer of
Albireo. “We have a two-pronged approach for NASH development:
advancing elobixibat, a well-characterized IBAT inhibitor, into a
Phase 2 trial and continuing to develop novel preclinical
compounds.”
NAFLD affects about 25 percent of the world’s population and is
a major cause of liver disease. NAFLD may progress to NASH, which
is characterized by liver inflammation and damage caused by a
buildup of fat in the liver. NASH coincides with high obesity rates
and diabetes and is projected to become the leading cause of liver
transplants in the United States. NASH patients have a 10-fold
greater risk of liver-related mortality, compared with the general
population. There is currently no approved pharmacologic treatment
for NASH.
There is a strong rationale for bile acid modulation as a
therapeutic approach in NASH from an efficacy and
safety/tolerability perspective. Key markers in NASH patients
include elevated bile acid levels, elevated cholesterol, insulin
sensitivity, liver inflammation and liver fibrosis. Clinical and
preclinical data indicate that IBAT inhibitors may have a positive
impact on these parameters. Elobixibat, an innovative IBAT
inhibitor approved last year in Japan for chronic idiopathic
constipation, has minimal systemic exposure and a safety database
with more than 1,500 patient exposures. Elobixibat could have
potential in NASH as either monotherapy or combination therapy.
The planned Phase 2 clinical trial is a randomized,
double-blinded, placebo-controlled, multicenter trial designed to
assess the efficacy and safety of elobixibat in approximately 46
adults with biopsy-confirmed NASH or suspected diagnosis of
NAFLD/NASH based on metabolic syndrome definitions. Treated
patients will receive 5 mg of elobixibat once daily for 16 weeks.
The primary endpoint will be the assessment of change in
low-density lipoprotein (LDL) cholesterol, and secondary endpoints
include the assessment of change in liver fat by imaging, and
alanine transaminase (ALT) and serum bile acids levels. The study
should be initiated in the second quarter of 2019, with results
planned for mid-2020.
About Elobixibat The first ileal bile acid
transporter (IBAT) inhibitor approved globally, elobixibat is
approved in Japan for the treatment of patients with
chronic constipation (excluding constipation caused by organic
disease). It is marketed and sold in Japan under the trade
name GOOFICE®.
About Albireo Albireo Pharma is a
clinical-stage biopharmaceutical company focused through its
operating subsidiary on the development of novel bile acid
modulators to treat orphan pediatric liver diseases, and other
liver and gastrointestinal diseases and disorders. Albireo’s lead
product candidate, A4250, is being developed to treat rare
pediatric cholestatic liver diseases and is in Phase 3 development
in its initial target indication, progressive familial intrahepatic
cholestasis (PFIC). Albireo’s clinical pipeline also includes two
Phase 2 product candidates. Albireo’s elobixibat, approved
in Japan for the treatment of chronic constipation, is
the first ileal bile acid transporter (IBAT) inhibitor
approved anywhere in the world. Albireo was spun out
from AstraZeneca in 2008.
Albireo Pharma is located
in Boston, Massachusetts, and its key operating
subsidiary is located in Gothenburg, Sweden. For more
information on Albireo, please
visit www.albireopharma.com.
Forward-Looking Statements This press release
includes “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of
1995. Forward-looking statements include statements, other
than statements of historical fact, regarding, among other things:
the plans for, or progress, scope, cost, duration or results or
timing for availability of results of, development of elobixibat or
any other Albireo product candidate or program; the target
indication(s) for development, the size, design, population,
location, conduct, objective, duration or endpoints of any clinical
trial, or the timing for initiation or completion of or reporting
of results from any clinical trial, including the Phase 2 trial for
elobixibat in NAFLD/NASH; the size of the NASH population, or any
other disease population for indications that may be targeted by
Albireo; the potential benefits or competitive position of
elobixibat, or any other Albireo product candidate or program or
the commercial opportunity in any target indication; the period for
which Albireo’s cash resources will be sufficient to fund its
operating requirements (runway); or Albireo’s plans, expectations
or future operations, financial position, revenues, costs or
expenses. Albireo often uses words such as “anticipates,”
“believes,” “plans,” “expects,” “projects,” “future,” “intends,”
“may,” “will,” “should,” “could,” “estimates,” “predicts,”
“potential,” “planned,” “continue,” “guidance,” and similar
expressions to identify forward-looking statements. Actual results,
performance or experience may differ materially from those
expressed or implied by any forward-looking statement as a result
of various risks, uncertainties and other factors, including, but
not limited to: the timing for initiation or completion of, or for
availability of data from, clinical trials, including the Phase 2
trial of elobixibat in NAFLD/NASH, and the outcomes of such
trials; Albireo’s ability to obtain coverage, pricing or
reimbursement for approved products in the United States or
European Union; delays or other challenges in the recruitment of
patients for, or the conduct of, clinical trials, including the
Phase 2 clinical trial of elobixibat in NAFLD/NASH; and Albireo’s
critical accounting policies. These and other risks and
uncertainties that Albireo faces are described in greater detail
under the heading “Risk Factors” in Albireo’s most recent Annual
Report on Form 10-K or in subsequent filings that it makes with the
Securities and Exchange Commission. As a result of risks and
uncertainties that Albireo faces, the results or events indicated
by any forward-looking statement may not occur. Albireo cautions
you not to place undue reliance on any forward-looking statement.
In addition, any forward-looking statement in this press release
represents Albireo’s views only as of the date of this press
release and should not be relied upon as representing its views as
of any subsequent date. Albireo disclaims any obligation to update
any forward-looking statement, except as required by applicable
law.
Investor Contact:Hans
Vitzthum
LifeSci Advisors,
LLC
212-915-2568
Media Contact:Heather Anderson 6
Degrees980-938-0260 handerson@6degreespr.com
Source: Albireo Pharma, Inc.
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