Ascletis drops FXR agonistFXR agonist after disappointing mid-stage PBC data
03 Apr 2024
Phase 2Clinical ResultDrug Approval
Ascletis Pharma is pulling the plug on its farnesoid X receptor (FXR) agonist ASC42, which was being developed across multiple indications. The move follows an analysis of Phase II efficacy and safety data in primary biliary cholangitis (PBC), revealing that ASC42 "did not show competitiveness" compared to other drug candidates currently in late-stage testing for the same indication.
In addition to halting the PBC programme, Ascletis is also terminating further clinical studies of ASC42 as part of a combination regimen for metabolic dysfunction-associated steatohepatitis (MASH), formerly referred to as non-alcoholic steatohepatitis (NASH), and as a monotherapy for hepatitis B virus infection.
Speed work on other MASH assets
Ascletis says the savings generated from discontinuing the planned clinical trials will be redirected towards accelerating development of two other potential MASH candidates, ASC41 and ASC40, as well as supporting the Chinese biotech's in-house discovery efforts.
ASC41 is a once-daily oral THRβ agonist that led to significant reductions in fat content in patients with biopsy-confirmed MASH, according to interim Phase II results unveiled earlier this year. The compound is in the same class as Madrigal Pharmaceuticals' Rezdiffra (resmetirom), which became the first approved MASH treatment when US regulators signed off on it last month.
Ascletis' drug has also been at the centre of a dispute with Viking Therapeutics, which claimed that ASC41 is based on stolen trade secrets revolving around its own THRβ drug, VK2809.
Meanwhile, Asceltis said its FASN inhibitorFASN inhibitor ASC40, also known as denifanstat, achieved statistically significant results for both MASH resolution and fibrosis improvement in a Phase IIb study of NASH patients with stage 2 or 3 fibrosis after 52 weeks of treatment. ASC40 is also in late-stage development as an acne treatment, and in combination with bevacizumab for patients with recurrent glioblastoma.
The company's most advanced drug candidate is ASC22, a subcutaneously injected PD-L1 antibody currently in Phase II as a potential functional cure for both chronic hepatitis B and HIV.
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