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Biopharma Achieves 'Big Phase 3 Win' for its Pediatric Intrahepatic Cholestasis Drug
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The recent study results of Albireo Pharma's lead therapeutic candidate are discussed in an H.C. Wainwright & Co. report.

In a Sept. 8 research note, H.C. Wainwright & Co. analyst Ed Arce reported that Albireo Pharma Inc. (ALBO:NASDAQ) announced positive topline results from the global, Phase 3 PEDFIC 1 trial evaluating odevixibat as a treatment for children with progressive familial intrahepatic cholestasis (PFIC).

"Odevixibat achieved high statistical significance in both primary endpoints and key secondary endpoints," Arce noted.

In accounting for the results in its model on Albireo, H.C. Wainwright raised its target price on the biopharma to $67 per share from $50. The new target is more than double the current share price of $40.78.

Specifically, the financial institution increased the probability of success of odevixibat in progressive familial intrahepatic cholestasis to 87% from 63%. It did the same with the probability of success of Albireo getting a priority review voucher and executing its subsequent sale in 2022 for about $95 million in cash.

PEDFIC 1 study results showed that Albireo's lead drug candidate odevixibat met the U.S. Food and Drug Administration's (FDA's) primary endpoint of pruritus improvement, in 53.5% of odevixibat patients (aged 3 months to 16 years) versus 28.7% on placebo (p=0.004) and the European Union's primary endpoint of serum bile acid reduction, in 33.3% of odevixibat patients versus none on placebo (p=0.003). As a secondary endpoint, the absolute change in pruritus was -1.13 on odevixibat compared to -0.25 on placebo (p=0.020).

"Importantly, from a commercial perspective, 42.9% of patients on odevixibat had a clinically meaningful improvement in pruritus (greater than or equal to 1 point drop) at week 24, versus 10.5% on placebo (p=0.018)," indicated Arce.

Both of the administered doses of odevixibat, 40 and 120 micrograms per kilogram per day, delivered orally, met the endpoints in a statistically significant way. As for the drug's safety, the occurrence of treatment-emergent adverse events was similar to that with placebo, but serious adverse events were fewer on odevixibat than on placebo.

"Overall, we are quite pleased with the PEDFIC 1 results, given [odevixibat's] strong efficacy across the board and clean safety profile consistent with prior data," commented Arce. "In short, this morning's data are a big win for Albireo."

Arce noted that Albireo's timeline for odevixibat is to finish filing the new drug application and the MMA by early 2021. Then by H2/21, the company expects to have received potential FDA approval of odevixibat for pediatric PFIC and to have commercially launched the drug in the States.

H.C. Wainwright rates Albireo a Buy.

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Disclosure:
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Disclosures from H.C. Wainwright & Co., Albireo Pharma Inc., Target Price Revision, September 8, 2020

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Ed Arce, 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. and Mirum Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of August 31, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Albireo Pharma, Inc. and Mirum Pharmaceuticals, Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know 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. and Mirum Pharmaceuticals, 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.

The Firm does not make a market in Albireo Pharma, Inc. and Mirum Pharmaceuticals, Inc. as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.




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