Albireo Pharma Inc.'s (ALBO:NASDAQ) drug Bylvay (odevixibat) met the primary efficacy endpoints in the pivotal Phase 3 PEDFIC 1 trial in progressive familial intrahepatic cholestasis (PFIC), reported H.C. Wainwright & Co. analyst Ed Arce in a July 7 research note. A recent issue of The Lancet Gastroenterology & Hepatology featured the data.
"Overall, positive results of PEDFIC 1 not only provided the basis for Bylvay's U.S. Food and Drug Administration and European Medicines Agency approvals for PFIC but also support its use as a nonsurgical, pharmacological option to interrupt the enterohepatic circulation, leading to significant clinical and quality of life benefits for PFIC patients," Arce wrote.
The analyst noted the two primary endpoints that Bylvay met in the PEDFIC 1 trial, via statistically significant results, were improvements in pruritus severity scores and reductions in serum bile acid levels.
As for pruritus, more patients treated with Bylvay (55%) than patients who received a placebo (30%) showed a positive response on assessment. Regarding serum bile acid levels, 33% of Bylvay group patients compared to 0% of placebo group patients demonstrated improvements.
Arce pointed out that Bylvay had a positive effect in terms of PEDFIC 1's secondary efficacy endpoints, too. Those metrics were clinically meaningful improvements in pruritus at certain points in time. Patients in the all-Bylvay group exhibited this as early as week four. At week 24, 43% of Bylvay-treated patients experienced this as opposed to 11% of placebo-receiving patients.
With respect to the safety of Bylvay, it was well-tolerated in the trial, indicated Arce, and none of the participants reported any drug-related serious adverse events during it. The incidence of adverse events was equal to that associated with placebo.
Arce highlighted that the next major catalyst for Albireo will be the topline data readout from the pivotal Phase 3 ASSERT study, expected in H2/22. The objective of ASSERT is to evaluate the safety and efficacy of 24-week treatment with Bylvay 120 micrograms per kilogram per day. The study is being conducted globally, at clinical sites in North America, Europe, the Middle East, and the Asia Pacific.
"We anticipate positive data from ASSERT to support Bylvay's approval for Alagille syndrome," Arce wrote.
H.C. Wainwright maintained its Buy rating and $80 per share price target on Albireo. Its stock, in comparison, is trading now at around $24.50 per share.
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Disclosures for H.C. Wainwright & Co., Albireo Pharma Inc., July 7, 2022
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Ed Arce and Thomas Yip, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst’s household has a financial interest in the securities of Albireo Pharma, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of June 30, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Albireo Pharma, Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Albireo Pharma, Inc. for non-investment banking services in the previous 12 months.
The Firm or its affiliates did not receive compensation from Albireo Pharma, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
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