Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan
pediatric liver disease company developing novel bile acid
modulators, today announced that it will host a Key Opinion Leader
(KOL) call on clinical outcome assessments (COAs) on Tuesday, June
16th at 8:00 am Eastern Time.
This call will feature a presentation by KOL Chad Gwaltney,
Ph.D. who will discuss key considerations for the design and
implementation of COAs, including patient-reported and
observer-reported outcomes, in clinical trials. His presentation
will review best practices for identifying key patient experiences
and developing and testing COAs that will be used to evaluate
efficacy in clinical development programs.
As a key contributor to the development of the PRUCISION
pruritus measurement tools used by Albireo in the Phase 3 studies,
Dr. Gwaltney will discuss the creation of the careful design of
PRUCISION to measure treatment benefits. He and the Albireo
management team will also be available to answer questions at the
conclusion of the event.
Albireo Chief Medical Officer Patrick Horn, M.D., Ph.D. will
provide an overview of the company’s registrational Phase 3
clinical trial of odevixibat for the treatment of patients with
progressive familial intrahepatic cholestasis (PFIC), a rare
pediatric cholestatic liver disease. Albireo is developing
odevixibat, a potent and selective inhibitor of the ileal bile acid
transporter (IBAT), to treat patients with PFIC, biliary atresia
and Alagille syndrome.
Conference
Call Details |
Tuesday,
June 16th @ 8:00am Eastern Time |
Domestic: |
877-407-0792 |
International: |
201-689-8263 |
Conference ID: |
13702827 |
Webcast: |
Click Here For Webcast |
Chad Gwaltney, Ph.D. is President and Principal Consultant at
Gwaltney Consulting. Dr. Gwaltney develops innovative methods to
measure patient-centered outcomes in clinical trials. His academic
and industry research includes the design of electronic platforms
for the collection of information in real-time in the patient’s
natural environment. He has published over 85 peer-reviewed
articles and book chapters addressing patient-reported outcomes and
how the patient’s perspective can be examined to better understand
medical product efficacy and safety. He has served on U.S. National
Institutes of Health review committees and has co-authored industry
best practice guidelines on the development and use of
patient-reported outcomes. Dr. Gwaltney has also served as Head,
Patient Experience, Hematology/Oncology, at Celgene and as a
research faculty member in the Brown University School of Public
Health.
About AlbireoAlbireo 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 progressive familial intrahepatic cholestasis (PFIC) and biliary
atresia, with a third Phase 3 trial being planned in Alagille
syndrome. 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 StatementsThis 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, initiation, duration,
enrollment, results or timing for availability of results of,
development of odevixibat, elobixibat or any other Albireo product
candidate or program, including regarding expectations regarding
the impact of COVID-19 on our business and our ability to adapt our
approach as appropriate; the Phase 3 clinical program for
odevixibat in patients with PFIC, the pivotal trial for odevixibat
in biliary atresia, the planned pivotal trial for odevixibat in
Alagille syndrome, the Phase 2 clinical trial for elobixibat in
NAFLD/NASH, and another Phase 3 trial for elobixibat being
conducted by EA Pharma in Japan; the target indication(s) for
development or approval, the size, design, population, location,
conduct, cost, objective, enrollment, duration or endpoints of any
clinical trial, or the timing for initiation or completion of or
availability or reporting of results from any clinical trial,
including the Phase 3 PFIC trial for odevixibat, and the long-term
open-label extension study, the pivotal trial for odevixibat in
biliary atresia, the planned pivotal trial for odevixibat in
Alagille syndrome, or the Phase 2 trial for elobixibat in
NAFLD/NASH; the potential approval and commercialization of
odevixibat; discussions with the FDA or EMA regarding our programs;
the potential benefits or competitive position of odevixibat,
elobixibat, or any other Albireo product candidate or program or
the commercial opportunity in any target indication; the potential
benefits of an orphan drug designation; 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: negative impacts of the COVID-19 pandemic,
including on manufacturing, supply, conduct or initiation of
clinical trials, or other aspects of our business; 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, the pivotal program
in biliary atresia or the planned pivotal program in Alagille
syndrome, 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 or other pivotal trials; 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, 617-430-7578Media Contact: Claire
LaCagnina, 6 Degrees, 315-765-1462, clacagnina@6degreespr.com
Source: Albireo Pharma, Inc.
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