Primary Biliary Cholangitis is a rare, progressive, chronic autoimmune disease of the liver in which the small bile ducts are gradually destroyed, causing bile and other toxins to build up in the liver (known as cholestasis). Further damage can lead to scarring, fibrosis and eventually cirrhosis of the liver. Ursodeoxycholic acid (UDCA) and Intercept Pharma’s Ocaliva are some of the FDA-approved drugs for primary biliary cholangitis.
The company we are profiling today is Genfit S.A. (GNFT) which is also developing a therapeutic for primary biliary cholangitis.
The drug candidate in focus is Elafibranor, an oral, once-daily, first-in-class drug candidate acting via dual agonism of peroxisome proliferator-activated alpha/delta receptors.
Peroxisome proliferator-activated receptors are said to play a role in regulating hepatic immunity and help in the treatment of primary biliary cholangitis.
Elafibranor is under a phase III trial in patients with primary biliary cholangitis, dubbed ELATIVE.
Genfit signed an agreement in December 2021, giving Ipsen S.A. (IPSEY.OB) exclusive worldwide license to develop, manufacture and commercialize Elafibranor, for people living with Primary Biliary Cholangitis.
The company expects topline results from the ELATIVE study to be reported towards the end of this quarter.
Under the agreement with Ipsen, Genfit is eligible to receive regulatory, commercial, and sales-based milestone payments up to €360 million, with a potential first significant milestone payment as early as 2023 and an additional potential milestone payment in 2024, if ELATIVE is successful. In addition, GENFIT is eligible for double-digit royalties of up to 20%.
VS-01, NTZ and SRT-015 for the treatment of Acute-on-Chronic Liver Failure, and GNS561 for the treatment of cholangiocarcinoma are the company’s other investigational products.
Acute-on-Chronic Liver Failure (ACLF) is a condition that carries significant morbidity and mortality risks.
— VS-01 is currently being evaluated in a global phase II proof of concept study to assess its efficacy, safety, and tolerability in addition to standard of care (SOC), compared to SOC alone, in adult patients with ACLF grades 1 and 2 and ascites. Data from this study is expected to be available in the first half of 2024.
— NTZ is expected to advance into a phase II study in patients with ACLF grades 1 and 2 the second half of 2023.
— SRT-015, licensed from Seal Rock Therapeutics as recently as last month, is expected to progress into a first-in-human study in the second half of 2024.
As for GNS561, the company has plans to screen the first patient for its phase 1b/2a study of GNS561 in cholangiocarcinoma towards the end of this quarter.
Genfit ended March 31, 2023, with cash, cash equivalents and financial assets of €128.6 million.
GNFT has traded in a range of $3.06 to $5.05 in the last 1 year. As of this writing, the stock is down nearly 3% at $4.23.
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