Inventiva Announces Last Visit by Last Patient in its Phase IIb SSc Trial and Second Positive DSMB Review in its Phase IIb NASH Trial with Lanifibranor

Inventiva Announces Last Visit by Last Patient in its Phase IIb SSc Trial and Second Positive DSMB Review in its Phase IIb NASH Trial with Lanifibranor

• Top-line results of the Phase IIb systemic sclerosis (SSc) trial are expected for early 2019
   
• Second NASH DSMB recommends to continue the trial with lanifibranor without changing the protocol

Daix (France), October 15, 2018 - Inventiva S.A. ("Inventiva" or the "Company"), a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), today announced the last visit by the last patient in its Phase IIb FASST (For A Systemic Sclerosis Treatment) trial as well as the second positive review of the Data Safety Monitoring Board (DSMB) in its Phase IIb NATIVE (NASH Trial to Validate IVA337 Efficacy) trial, both conducted with lanifibranor.

The last visit of the last patient of the 12-month FAAST study took place on October 12 and data-base lock is planned for early January 2019. With this positive background, the Company confirmed that it expects to announce top-line results of the study in early 2019 as previously announced.

"SSc is a debilitating disease with no disease-modifying treatments approved so far where lanifibranor mechanism of action could prove beneficial for our patients. Given that all three DSMB meetings regarding the FASST trial recommended to pursue with the study without any modifications to the protocol, we are very eager to see the results of this study," said Yannick Allanore, co-principal investigator of the FASST trial and professor of rheumatology at the Hôpital Cochin in Paris.

Professor Christopher Denton, co-principal investigator of the FASST trial and professor at the University College London, added: "The FASST trial is a long-term study in SSc patients that will evaluate clinical endpoints highly relevant to clinicians, patients and health authorities. Positive results in this study would therefore be very supportive to the development of lanifibranor as a treatment in this very severe disease."

Additionally, the DSMB from the Company's NATIVE trial in NASH patients held its second meeting. Out of the 101 patients randomized so far, the DSMB had access to the data of 95 patients of which 36 had completed the 6 month treatment period of the study. Based on its analysis, the DSMB recommended the study to continue without any modification of the protocol.