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GENFIT Further Strengthens its ACLF Franchise with a Third Clinical-Stage Asset

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Summation

  • Taken together, safety and pharmacokinetic results, as well as exploratory pharmacodynamic data, support further clinical development of NTZ in patients with ACLF, and a Phase 2a proof of concept study with NTZ in patients with ACLF grades 1 and 2 is currently under discussion with the FDA.
  • VS-01 is currently being evaluated in the international UNVEIL-IT™ Phase 2, open-label, randomized, controlled, multi-center, 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.
  • GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases characterized by high unmet medical needs, today announced it has licensed the exclusive worldwide rights of ASK1 Inhibitor SRT-015 (injectable formulation in acute liver disease2) from Seal Rock Therapeutics, a Seattle, Washington (USA) based clinical stage company developing first-in-class and best-in-class kinase inhibitors.

GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases characterized by high unmet medical needs, today announced it has licensed the exclusive worldwide rights of ASK1 Inhibitor SRT-015 (injectable formulation in acute liver disease2) from Seal Rock Therapeutics, a Seattle, Washington (USA) based clinical stage company developing first-in-class and best-in-class kinase inhibitors.

ASK1 inhibition: a therapeutic strategy with multi-system benefits

ASK1 inhibition has shown several potentially beneficial effects that may be relevant in ACLF, such as blocking LPS (lipopolysaccharide) associated hyperinflammatory response, reducing the ROS (Reactive Oxygen Species)-related immune response, reducing apoptosis, reducing release of the proinflammatory cytokines, reducing fibrosis, and protecting macrophage mitochondrial function.

Multi-organ benefits have been observed in several animal models and clinical trials 3:

  • In kidney diseases, ASK1 modulation limits renal inflammation, apoptosis and fibrosis
  • In liver diseases, ASK1 modulation prevents hepatocyte death, inflammation and fibrosis
  • In brain disorders, ASK1 modulation limits neurodegeneration
  • In inflammatory diseases, ASK1 modulation limits damaging immune responses, and
  • In cardiopulmonary disease, ASK1 modulation slows the onset of heart failure.

Pascal Prigent, CEO of GENFIT commented: “We are excited to be announcing this licensing deal which marks an additional milestone in the execution of our development strategy in liver diseases with high unmet medical needs. ACLF is a complex disorder that will likely require the combination of different approaches and with this acquisition, we continue to strengthen our leadership in this indication. We now have a unique portfolio of three differentiated clinical stage programs in ACLF. Considering its liver-centric activity, the potential for multi-organ benefits and the breadth of evidence supporting further development in ACLF, we strongly believe in the potential of SRT-015.”

Under the agreement, Seal Rock Therapeutics is eligible for payments up to €100 million, including regulatory, clinical, and commercial milestone payments, plus tiered royalties.

Other assets in GENFIT’s ACLF franchise

In ACLF, whose market size has been estimated by IQVIA to reach almost $4 billion in the US and in the five main European countries by 2030, GENFIT is developing two other assets: VS-01 and NTZ.

  • VS-01

VS-01 is currently being evaluated in the international UNVEIL-IT™ Phase 2, open-label, randomized, controlled, multi-center, 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.

IND (Investigational New Drug) was in effect as of April 17, 2023, and the first patient is expected to be screened and enrolled in the Phase 2 trial in the coming days. It is planned that approximately 60 adult patients with ACLF grades 1 and 2 will be enrolled in this trial. Patients will be randomized in a 1:1 ratio to receive either daily intraperitoneal administration of VS-01 over 4 days on top of SOC (active treatment group) or SOC alone (control group).

The primary objective of the study is to measure efficacy using the Chronic Liver Failure Consortium (CLIF-C) ACLF4 score at day 7.

Data expected to be available in the first half of 2024 should support preparation of further testing of efficacy. Given the high unmet need in this indication and the Orphan Drug Designation obtained from the US Food and Drug Administration for VS-01, it is expected that the program qualifies for some of the expedited regulatory pathways provided by health authorities.

  • NTZ

Preliminary data from two Phase 1 studies recently conducted in subjects with renal impairment and subjects with hepatic impairment supported a favorable safety and tolerability profile. Taken together, safety and pharmacokinetic results, as well as exploratory pharmacodynamic data, support further clinical development of NTZ in patients with ACLF, and a Phase 2a proof of concept study with NTZ in patients with ACLF grades 1 and 2 is currently under discussion with the FDA.

ABOUT ACLF

Acute-on-Chronic Liver Failure is a rare, life-threatening, but potentially reversible condition of varied etiology. ACLF is recognized clinically as a syndrome, globally defined by multi-organ dysfunction and failure in patients with chronic liver disease or liver cirrhosis and high short-term mortality within a period of 28 to 90 days.

Patients with cirrhosis may initially be compensated. With progression, many patients will go on to have acute decompensation of cirrhosis characterized by the rapid development of complications such as ascites, hepatic encephalopathy (HE), gastrointestinal hemorrhage, or bacterial infection, which are very common causes of hospitalization. On admission, approximately 30% of these patients will develop liver and/or other organ failure(s) (i.e, brain, kidneys, cardiovascular and respiratory) and will be considered as having ACLF.5 6 7 8 9

ABOUT GENFIT

GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs. GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanning more than two decades. Thanks to its expertise in bringing early-stage assets with high potential to late development and pre-commercialization stages, today GENFIT boasts a growing and diversified pipeline of innovative therapeutic and diagnostic solutions.

Its R&D pipeline covers six therapeutic areas via seven programs which explore the potential of differentiated mechanisms of action, across a variety of development stages (pre-clinical, Phase 1, Phase 2, Phase 3). These diseases are acute on-chronic liver failure (ACLF), hepatic encephalopathy (HE), cholangiocarcinoma (CCA), urea cycle disorders (UCD), organic acidemias (OA) and primary biliary cholangitis (PBC). Beyond therapeutics, GENFIT’s pipeline also includes a diagnostic franchise focused on NASH and ACLF.

GENFIT has facilities in Lille and Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). In 2021, IPSEN became one of GENFIT’s largest shareholders and holds 8% of the company’s share capital. www.genfit.com

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