Newly reported results from a terminated clinical trial provide positive information about atrasentan, which Chinook Therapeutics Inc. (KDNY:NASDAQ) is now assessing in IgA nephropathy in its Phase 3 ALIGN study, reported H.C. Wainwright & Co. analyst Ed Arce in an April 3 research note.
"This analysis provides an important long-term safety data set in a patient population [that is] at high risk of liver disease, while we wait for the topline proteinuria data readout from the ongoing Phase 3 ALIGN study," Arce wrote. ALIGN results are expected in Q4/23.
Original and Reporting Sources
Arce noted these new data are from AbbVie's Phase 3 SONAR trial evaluating atrasentan on renal outcomes in patients with type 2 diabetes and chronic kidney disease or diabetic kidney disease, and treated with the standard of care.
In SONAR, 1,834 participants were treated with atrasentan and 1,834 were given a placebo and followed long-term. The median follow-up period was 2.2 years. AbbVie terminated the study because fewer than expected primary endpoints had been achieved in it.
These SONAR data were reported at the recent ISN World Congress of Nephrology 2023 meeting in a poster presentation called "Effects of Atrasentan on Markers of Liver Function in Patients with Type 2 Diabetes and Chronic Kidney Disease." Dr. Hiddo Heerspink at the University Medical Center in the Netherlands gave the presentation.
Efficacy and Safety Highlights
Arce shared some of the noteworthy data points from the SONAR trial, which Heerspink presented.
In the study, patients treated with atrasentan showed rapid and sustained proteinuria reduction and preserved kidney function, wrote Arce. These patients, when compared to those given a placebo, experienced statistically significant reductions in levels of ALT (alanine transaminase), AST (aspartate aminotransferase), and ALP (alkaline phosphatase).
As for safety, Arce noted, no drug-induced liver injuries, signs of liver function abnormalities, or liver-related adverse effects occurred in SONAR patients treated with atrasentan. The liver-related emergent adverse effects that did happen were comparable between atrasentan-treated patients and placebo-administered patients.
H.C. Wainwright affirmed its Buy rating and US$31 per share price target on Chinook, which is currently trading at about US$23.15 per share.
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Disclosures For H.C.Wainwright & Co., Chinook Therapeutics Inc., April 3, 2023
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 Chinook Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of March 31, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Chinook Therapeutics, 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.
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