INVENTIVA advances in the development of lanifibranor with the achievement of three key milestones

Inventiva advances in the development of lanifibranor with the achievement of three key milestones

• New patent granted by the USPTO protecting the use of lanifibranor in numerous fibrotic diseases
• Enrolment of first patient in the United States Phase II study for the treatment of NAFLD in patients with type 2 diabetes
• FDA approval of the IND application enabling to launch the clinical development plan in the United States

Daix (France), August 30, 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 successful completion of three key milestones in the development of its lead product, lanifibranor.

New patent granted by the USPTO protecting the use of lanifibranor in numerous fibrotic diseases

On August 21, 2018, the United States Patent and Trademark Office (USPTO) granted a new patent protecting until June 2035 the therapeutic use of lanifibranor in the treatment of various fibrotic conditions, including NASH and SSc.

This patent strengthens and extends in the United States the term of protection of lanifibranor derived from the New Chemical Entity (NCE) patent expiring in December 2031 (this expiration date includes a possible five-year extension to compensate for regulatory delays in obtaining the marketing approval).

Enrolment of the first patient in the United States Phase II study for the treatment of NAFLD in patients with type 2 diabetes

Following the agreement with the University of Florida to conduct a Phase II study in the United States with lanifibranor for the treatment of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes, the first of 64 patients for this study has been enrolled in August 2018. The recruitment of the other patients continues in accordance with the planned schedule and top line results are expected in early 2020.

The overall objective of the study , led by Dr Kenneth Cusi, Head of the Department of Endocrinology, Diabetes & Metabolism in the Department of Medicine at the University of Florida at Gainesville, is to measure the metabolic improvements induced by lanifibranor, as well as its effects on hepatic steatosis in patients with type 2 diabetes and NAFLD. In addition, this study will examine the impact of lanifibranor on fibrosis using the latest imaging and biomarker technologies.

FDA approval of the IND application enabling to launch the clinical development plan in the United States

On August 24, 2018, the Company received the approval of its IND (Investigational New Drug) application from the gastroenterology division of the FDA (Food and Drug Administration) for lanifibranor in order to conduct a drug interaction study required to pursue the development program.

This approval is an important milestone as it will allow Inventiva to use this IND to initiate further clinical studies for lanifibranor's development in NASH in the United States.

Frédéric Cren, CEO and co-founder of Inventiva, said: "These three important achievements demonstrate the continued progress made in the clinical development of lanifibranor and confirm our confidence in the future of our lead product. The new patent granted by the USPTO is a tangible proof of the innovative nature of our therapeutic approach with lanifibranor and above all extends the date of exclusivity by several years."

About lanifibranor

Lanifibranor is a next generation panPPAR modulator, designed as a moderately potent and well balanced PPAR alpha, gamma and delta. This unique profile was conceived in order to obtain an optimal therapeutic margin with strong efficacy and tolerance. Inventiva is currently evaluating lanifibranor in two parallel Phase IIb clinical studies in NASH and SSc.

About Inventiva : www.inventivapharma.com 

Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva's research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 highly qualified employees and owns state-of-the-art R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

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Please refer to the "Document de référence" filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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