Enanta To Discontinue Internal Development Of NASH Candidates

  • After looking at interim phase 2b data, Enanta Pharmaceuticals Inc ENTA has decided to stop the monotherapy trial of EDP-305 for non-alcoholic steatohepatitis (NASH).
  • Instead, Enanta now plans to prioritize combination approaches through out-licensing arrangements.
  • The company has two NASH candidates, EDP-305 and EDP-297, in the clinic. Both drugs are FXR agonists.
  • Neither candidate has done enough to persuade Enanta to continue internal development.
  • Enanta is stopping the phase 2b trial of EDP-305 that began last year after an interim analysis of the 12-week data. 
  • Enanta had the option to switch its focus to its follow-up candidate. However, a Phase 1 trial suggested EDP-297 is "not substantially differentiated" from EDP-305. 
  • The phase 1 study "found the overall balance of activity and tolerability was comparable to that of EDP-305." 
  • Price Action: ENTA stock closed down by 1.26% at $60.19 on Monday.
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