Inventiva receives FDA Breakthrough Therapy designation for lead drug candidate lanifibranor in NASH - Seite 2

Inventiva is expected to hold the end of NATIVE Phase IIb clinical trial meeting with the FDA and to receive regulatory feedback from the EMA during the fourth quarter of 2020 with the initiation of the Phase III clinical trial evaluating lanifibranor in NASH planned for the first half of 2021.

Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, commented: “Ahead of our end of Phase IIb meeting with the FDA later this year, the Breakthrough Therapy designation for lanifibranor is a fantastic achievement and a regulatory recognition of the significant clinical benefits lanifibranor could provide to NASH patients as shown in our recent NATIVE Phase IIb clinical trial. This new status will allow us to pursue lanifibranor’s development towards a safe and effective treatment for this devastating disease and we look forward to continue working closely with the FDA to this end."

About Breakthrough Therapy designation⁵

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs in the United States that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

A drug that receives Breakthrough Therapy designation is eligible for the following:

• All Fast Track designation features ;
• Intensive guidance on an efficient drug development program, beginning as early as Phase 1 ;
• Organizational commitment involving senior managers.

About lanifibranor

Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator‑activated receptor (PPAR) isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well‑balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan‑PPAR agonist in clinical development. Inventiva believes that lanifibranor’s moderate and balanced pan‑PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre‑clinical studies to date.