Inventiva rewarded for its innovative approach with IVA337 at the 4th Systemic Sclerosis World Congress

February 25, 2016

> Presentation on IVA337’s anti?fibrotic properties receives award and picked out from over 400 submissions

> Oralpresentation by Professor Yannick Allanore, Professor of Rheumatology at Hôpital Cochin, on the preventive and curative properties of IVA337 in a systemic sclerosis model

> Confirmation of IVA337’s potential in the treatment of systemic sclerosis (phase IIb trial ongoing)

Daix (France), February 25th 2016 – Inventiva, a biopharmaceutical company specialised in nuclear receptors, transcription factors and epigenetics for the development of innovative therapies for fibrosis, oncology and orphan diseases, announces that the organising committee of the 4th Systemic Sclerosis World Congress awarded Inventiva with a prize for the innovative approach it has taken with its lead product, IVA337, currently in a Phase 2b trial for the treatment of systemic sclerosis.

The research presented shows that IVA337 can treat the fibrosis of organs affected by systemic sclerosis via a unique mechanism of action. More than 400 submissions were presented at this congress of reference held by the World Scleroderma Foundation which brings together for three days the world experts of the disease and representatives from patient associations.

In its poster entitled “Pan PPAR agonist IVA337 has an anti?fibrotic effect in multiple in vitro and in vivo fibrosis models;”, Inventiva demonstrated in several in vitro ;and in vivo ;fibrosis models (lungs, liver, kidneys, etc.) the anti?fibrotic action of its lead product IVA337, a next?generation Pan PPAR agonist. This provides further evidence of the major role played by PPARs in fibrogenesis.

Additional data concerning the effects of IVA337 on skin fibrosis were also presented during the Congress by Professor Yannick Allanore, Professor of Rheumatology at Hôpital Cochin in Paris, in his presentation entitled: “Pan PPAR agonist IVA337 is effective in prevention and treatment of experimental skin fibrosis”.

We are very proud to have been selected from over 400 high?level research submissions presented at this Congress, which is the most important scientific global event in the field of systemic sclerosis,;” commented Pierre Broqua, Chief Scientific Officer and co?Founder of Inventiva. “This recognition reflects IVA337’s promising therapeutic potential, not only in systemic sclerosis, but also in other indications involving fibrosis, such as NASH, for which no effective treatments exist yet.

Alongside the ongoing phase IIb trial in the treatment of systemic sclerosis, in which it plans to enrol a total of 135 patients in 8 European countries, Inventiva also shortly intends to launch a phase IIb clinical trial for the treatment of NASH. NASH is a severe fibrotic disease of the liver that may cause cirrhosis or cancer and that affects several million people worldwide.

About the Systemic Sclerosis World Congress:

The Systemic Sclerosis World Congress is held by the World Scleroderma Foundation, an organisation dedicated to initiating and supporting research into systemic sclerosis. This globally renowned conference aims to bring together and facilitate the sharing of expertise by all those involved in the field of systemic sclerosis through presentations, workshops and a programme specifically dedicated to patients.

About systemic sclerosis:

Systemic sclerosis is a rare and complex disease affecting the auto?immune system, the microvascular system and conjunctive tissues. This fibrotic disease mainly affects the skin, but also the lungs, the heart, the gastro? intestinal tract and the kidneys. Due to the progressive failure of different organs, systemic sclerosis is a severe disease with a high mortality rate. Once patients are diagnosed with systemic sclerosis, generally between the ages of 40 and 50, the median survival period is of 11 years. Close to 170,000 people suffer from systemic sclerosis, with women outnumbering men by a ratio of more than five to one1.

The disease owes its original name of scleroderma, which derives from the Greek words skleros (hard) and derma (skin), to the skin condition it provokes. The disease causes severe physical and psycho-social consequences that may be deadly for patients whose vital organs are affected. The extension of this skin fibrosis has led to the classification of two sub-categories, respectively called limited systemic sclerosis and diffuse systemic sclerosis. The latter is more serious and is targeted in the FASST trial.

To date, only symptomatic drugs with limited therapeutic effects are available in order to attenuate the consequences of fibrosis progression. However, they do not prevent, delay nor reverse the disease’s devastating process.

1 Journal of Rheumatology, 2013


Frédéric Cren

Chief Executive Officer
+33 3 80 44 75 00

Julien Trosdorf / Yannick Tetzlaff

Media relations
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations

About Inventiva
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 employees and owns 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.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

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.

Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.