A4250 is an ileal bile acid transporter (IBAT) inhibitor initially in development for the treatment of patients with PFIC, a rare and life-threatening genetic liver disorder for which there are currently no approved therapies. In addition to the ‘446 patent, Albireo has issued composition of matter coverage for A4250 in more than 50 countries, as well as a method of use patent in
"The allowance of this patent further fortifies our intellectual property protection for our lead product candidate, providing expected exclusivity into 2031 for A4250 in the
treatment of PFIC among other indications," said
Additionally, the USPTO allowed
A4250 is a first-in-class product candidate in development for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC) and potentially other orphan pediatric cholestatic liver diseases. A4250 is a highly potent and selective inhibitor of the ileal bile acid transporter (IBAT), has minimal systemic exposure and acts locally in the gut.
A4250 has been granted orphan drug designation for PFIC in
Albireo 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 clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008.
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: the progress or scope of development of A4250, including regarding the planned Phase 3 clinical program for A4250 in patients with PFIC; the timing for initiation of the planned Phase 3 PFIC program for A4250; the exclusivity provided by the allowed method of use patent for A4250 in the treatment of PFIC among other indications or the duration of the exclusivity; the competitive position of A4250 or the commercial opportunity in any target indication; 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 and uncertainties, including, but not limited to, risks and uncertainties relating to: Albireo's ability to protect and maintain its allowed method of use patents for A4250, when issued, and to expand its intellectual property estate for A4250; whether or for how long Albireo's allowed method of use patents for A4250, when issued, will provide market exclusivity for A4250, if approved by applicable regulatory authorities, in the treatment of PFIC or any other indication; whether preliminary data from the Phase 2 trial of A4250 in children with chronic cholestasis will be confirmed following database lock; whether favorable findings from clinical trials of A4250 to date, including findings in indications other than PFIC, will be predictive of results from future clinical trials of A4250, including the trials comprising the planned Phase 3 PFIC program; whether either or both of the
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