Albireo Pharma announced that USPTO (United States Patent and Trademark Office) has allowed U.S. Patent Application No. 15/276,446, “IBAT inhibitors for the treatment of liver diseases” (446 patent). Upon issuance, the regular term of the ‘446 patent will expire in November 2031. The ‘446 patent claims a method of treatment for Albireo’s lead product candidate A4250 in progressive familial intrahepatic cholestasis (PFIC) and other specified liver diseases.
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 Europe and Japan corresponding to the ‘446 patent. A4250 has also been granted orphan designation in the U.S. and the European Union.
Albireo President and CEO, Ron Cooper said that the allowance of this patent further fortifies their intellectual property protection for their lead product candidate, providing expected exclusivity into 2031 for A4250 in the treatment of PFIC among other indications. This patent allowance is another step forward in their efforts to bring a pharmacological treatment option for children with PFIC who greatly need it. They plan to initiate a Phase 3 clinical program for A4250 in PFIC patients in the second half of this year.
Additionally, the USPTO allowed U.S. Patent Application No. 15/069,355, “IBAT inhibitors for the treatment of liver diseases,” which claims a method of treatment for A4250 in nonalcoholic steatohepatitis (NASH).