Albireo announces patents, trial plans for PFIC treatment candidate

Albireo Pharma announced the approval of two U.S. patents and plans for a phase 3 trial of the company’s lead product candidate, A4250, an ileal bile acid transporter inhibitor in development for the treatment of patients with progressive familial cholestasis and other specified liver diseases, according to a press release.

“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,” Ron Cooper, president and CEO of Albireo, said in the release. “This patent allowance is another step forward in our efforts to bring a pharmacological treatment option for children with PFIC who greatly need it. We plan to initiate a phase 3 clinical program for A4250 in PFIC patients in the second half of this year.”

The United States Patent and Trademark Office allowed two separate U.S. Patent Applications entitled “IBAT inhibitors for the treatment of liver diseases,” the first of which is a method of treatment using A4250 for PFIC and the other which claims a method of treatment with A4250 for nonalcoholic steatohepatitis.

Previously, Albireo completed a phase 2 clinical trial of A4250 in children with cholestatic liver diseases to analyze the product’s safety and efficacy. Most patients had an improvement in pruritus across multiple scales and a reduction of serum bile acid levels after 4 weeks with no serious adverse events.

The phase 3 clinical trial is designed as a single randomized, double blind, placebo-controlled, multicenter, 6-month, open-label study. The researchers plan to enroll 60 patients. Key endpoints include the change in pruritus and serum bile acid responder rate.

In another company press release, Albireo announced that underwriting was completed for the public offering of 2.2 million shares of common stock at the public price of $20.50 per share.

Reference: www.albireopharma.com