Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan
pediatric liver disease company developing novel bile acid
modulators, today announced upcoming presentations at the North
American Society for Pediatric Gastroenterology, Hepatology and
Nutrition (NASPGHAN) 2019 Annual Meeting, being held October 16-19,
2019, in Chicago. The presentations will include pharmacological
data regarding the Company’s lead product candidate, odevixibat, as
well as background about the Company’s proprietary patient- and
observer-reported outcomes assessment tools for pruritus.
“When considering existing and emerging pediatric therapies,
there is a strong desire among physicians, parents and patients for
exposure levels to be concentrated in targeted areas of the body
while minimizing broader systemic exposure,” said Ron Cooper,
President and Chief Executive Officer of Albireo. “At NASPGHAN, we
will present data demonstrating this to be the case with
odevixibat. Additionally, we are looking forward to sharing
additional detail about the extensive efforts undertaken to develop
the proprietary patient- and observer-reported outcomes tools that
are being utilized to measure pruritus and sleep disturbance in our
ongoing pivotal Phase 3 trial of odevixibat in progressive familial
intrahapetic cholestasis (PFIC).”
Details of the NASPGHAN poster presentations are as follows:
- October 17 from 5-7 p.m. CDT: “Clinical pharmacology of
odevixibat, a potent, selective, ileal bile acid transport
inhibitor with minimal systemic exposure” – Abstract #167
- October 19 from 12-2:30 p.m. CDT: “Development of patient- and
observer-reported outcome (PRO and ObsRO) measures for paediatric
cholestatic liver diseases” – Abstract #592
The abstracts were published in the October issue of the Journal
of Pediatric Gastroenterology and Nutrition and can be viewed here:
https://journals.lww.com/jpgn/pages/default.aspx.
About OdevixibatOdevixibat is a product
candidate 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). A
highly potent and selective inhibitor of the ileal bile acid
transporter (IBAT), odevixibat has minimal systemic exposure and
acts locally in the small intestine.
Odevixibat is being evaluated in a Phase 3 clinical trial,
PEDFIC 1, in patients with PFIC subtype 1 or 2 (NCT03566238). The
PEDFIC 1 clinical trial is recruiting at 45 clinical trial sites
worldwide. More information may be found on
www.clinicaltrials.gov.
The odevixibat PFIC program has received fast track, rare
pediatric disease and orphan drug designation in the United States.
In addition, the FDA has granted orphan drug designation to
odevixibat for the treatment of Alagille syndrome, biliary atresia
and primary biliary cholangitis. The European Medicines Agency
(EMA) has granted odevixibat orphan designation, as well as access
to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC.
Its Pediatric Committee has agreed to Albireo's odevixibat
Pediatric Investigation Plan for PFIC. EMA also has granted orphan
designation to odevixibat for the treatment of Alagille syndrome,
biliary atresia and primary biliary cholangitis.
About Albireo Albireo Pharma is a
clinical-stage biopharmaceutical company focused 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, odevixibat, 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.
Elobixibat is in Phase 2 development in NAFLD and NASH. Approved in
Japan for the treatment of chronic constipation, elobixibat 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, Mass., and its key operating subsidiary is
located in Gothenburg, Sweden. The Boston Business Journal named
Albireo one of the 2019 Best Places to Work in Massachusetts. 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 odevixibat, elobixibat or any other
Albireo product candidate or program, including regarding the Phase
3 clinical program for odevixibat in patients with PFIC; the target
indication(s) for development, the size, design, population,
location, conduct, objective, enrollment, 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
double-blind Phase 3 PFIC trial for odevixibat; the potential
approval and commercialization of odevixibat; the size of the PFIC
population or any other disease population for indications that may
be targeted by Albireo; the potential benefits or competitive
position of odevixibat, or any other Albireo product candidate or
program or the commercial opportunity in any target indication.
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:
whether favorable findings from clinical trials of odevixibat to
date, including findings in indications other than PFIC, will be
predictive of results from the trials comprising the Phase 3 PFIC
program or any other clinical trials of odevixibat; whether either
or both of the FDA and EMA will determine that the primary endpoint
for their respective evaluations and treatment duration of the
double-blind Phase 3 trial in patients with PFIC are sufficient,
even if the primary endpoint is met with statistical significance,
to support approval of odevixibat in the United States or the
European Union, to treat PFIC, a symptom of PFIC, a specific PFIC
subtype(s) or otherwise; the outcome and interpretation by
regulatory authorities of the ongoing third-party study pooling and
analyzing of long-term PFIC patient data; the timing for initiation
or completion of, or for availability of data from, clinical trials
of odevixibat, including the trials comprising the Phase 3 PFIC
program, 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, the
double-blind Phase 3 trial; 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 Degrees, 980-938-0260, handerson@6degreespr.com
Source: Albireo Pharma, Inc.
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