IVA - Inventiva gets FDA nod to begin phase 2 trial to treat diabetes/liver disease

Inventiva (NASDAQ:IVA) said the U.S. Food and Drug Administration (FDA) concluded that a phase 2 trial of the company's drug lanifibranor in combination empagliflozin to treat patients with non-cirrhotic NASH and Type 2 Diabetes (T2D) may proceed. The decision was made by the FDA after the agency completed its safety review of the company's investigational new drug (IND) application to begin the proof-of-concept phase 2 trial, dubbed LEGEND, evaluating lanifibranor and empagliflozin (sold as Jardiance by Eli Lilly). "Our Phase IIb has successfully demonstrated that lanifibranor as a monotherapy could not only resolve NASH and improve fibrosis but also improve the lipids and glycemic profiles. We believe that a combination therapy with lanifibranor and empagliflozin can provide additional benefits and further improve the cardiometabolic risk profile of patients with NASH," said Inventiva Co-Founder and Chief Scientist Officer Pierre Broqua. The study, which is expected to enroll 63 patients, is expected to start in H1 2022 and top line results are

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Inventiva gets FDA nod to begin phase 2 trial to treat diabetes/liver disease