According to findings from a recent press release, Ascletis has decided not to pursue additional clinical trials of the farnesoid X receptor (FXR) agonist ASC42 for the treatment of patients with primary biliary cholangitis (PBC).
Following an in-depth evaluation of the phase 2 data studying ASC42 as a therapy for patients with PBC, a decision was reached not to continue further clinical trials of the agent for the treatment of this autoimmune disorder. The halt to additional investigation into treatment with ASC42 was based on efficacy and safety data derived from the 12-week, phase 2 analysis.
The phase 2 study of the agent evaluated the following 3 active treatment arms, which were compared with a placebo control arm:
- ASC42 dosed at 5 mg once daily
- ASC42 dosed at 10 mg once daily
- ASC42 dosed at 15 mg once daily
Results of the study revealed that “ASC42 did not show competitiveness to new PBC drug candidates currently in development and registrational stages.”
Read more about PBC therapies
Moreover, Ascletis made the decision not to continue additional clinical investigations of ASC42 as an FXR agonist used in combination for the treatment of nonalcoholic steatohepatitis (NASH; ASC43F), nor clinical studies of ASC42 for the treatment of chronic hepatitis B (CHB) infection.
“These strategic decisions are part of the Company’s efforts to continue to evaluate and optimize its research [and] development pipeline to increase efficiency and preserve cash,” the press release stated.
In fact, the savings realized from the discontinuation of these scheduled clinical trials will be utilized to accelerate the clinical development of ASC41 and ASC40 (denifanstat) for treating NASH, as well as “in-house discovery for global first-in-class or best-in-class drug candidates.”
Positive interim results with ASC41 in a phase 2 trial among biopsy-confirmed patients with NASH demonstrated use of the agent as a possible best-in-class thyroid hormone receptor β agonist.
Further, as a first-in-class fatty acid synthase (FASN) inhibitor, results of a phase 2b study demonstrated that ASC40 attained statistically significant results both for resolution of NASH, as well as for fibrosis improvement in biopsy-confirmed patients with NASH and stage 2/3 fibrosis, following 52 weeks of treatment.
As noted in the press release, “Ascletis is an innovative R&D driven biotech” [company]. “The most advanced drug candidates [of Ascletis] include ASC22 (CHB functional cure), ASC40 (acne), ASC40 (recurrent glioblastoma), ASC40 (NASH), ASC41 (NASH)[,] and ASC61 (advanced solid tumors).”tis announces strategic decisions on FXR agonist ASC42.
