Shots:

• The designation is based on the P-IIb NATIVE trial involves assessing lanifibranor vs PBO in patients with NASH for 24wks. Lanifibranor is the first drug candidate to be granted BTD in NASH since 2015
• The study met its 1EPs i.e. demonstrated significant reduction of SAF and 2EPs- including NASH resolution with no worsening of fibrosis- improvement of liver fibrosis with no worsening of NASH in both ITT and PP populations
• The company expected to hold the end of the P-IIb NATIVE trial meeting with the FDA and to receive regulatory feedback from the EMA in Q4’20. The designation supports the decision to initiate the P-III trial of lanifibranor in H1’21

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