Clinical StudiesLanifibranor

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Lanifibranor carcinogenicity studies: Progressing as planned and interim results in rats indicate no compound related urinary bladder tumors

March 28, 2018

Daix (France), March 28, 2018 – Inventiva, a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc), and mucopolysaccharidosis (MPS), today reported preliminary results of the two-year carcinogenicity studies with the pan-PPAR agonist lanifibranor in rats. Two carcinogenicity studies in rats and in mice were started in October 2015 after study protocol approval by the US Food and Drug Administration (FDA) and executed by Envigo (UK), a Contract Research Organization (CRO) with previous expertise in running similar studies, particularly with compounds from the PPAR class. These studies tested the effects of three doses of lanifibranor administered daily for a 104-week period, compared to control groups. This first in-life phase was conducted as planned and histopathology evaluation of the two studies is nearly completed. The peer-review phase of the two studies in rats and mice is expected to be finalized by the end of the second quarter 2018.

The peer-review is ongoing and preliminary results of the study in rats are already available, indicating that there are no compound-related incidences of neoplastic lesions, and in particular no increased incidence of urinary bladder cancer, a finding that was reported for several single or dual PPAR compounds. Lanifibranor’s moderate and balanced panPPAR profile and different chemical structure could explain the benign profile of the compound.

Doctor J. Armstrong, senior pathologist in charge of the peer-review, commented: “The peer-review is ongoing and preliminary results of the study in rats from the incident tables indicate a very benign safety profile of lanifibranor. I am particularly pleased that no primary urinary bladder neoplasms were diagnosed in the treated rats, a finding that was reported for several other PPAR compounds.”

Pierre Broqua, Chief Scientific Officer and a co-founder of Inventiva, added: “These preliminary results in rats are in line with the good safety profile of the moderately potent and well-balanced pan-PPAR agonist lanifibranor, demonstrated in long-term toxicological studies as well as in clinical Phase I and Phase II studies. Since bladder tumors have been associated with several different PPAR compounds, the carcinogenicity studies of lanifibranor are a critical part of the overall development package. While the study is not yet completed for both species, we are encouraged by the clean lanifibranor profile in the rat study, where there were no signs of increased bladder tumor incidence in any of the lanifibranor dose groups. We look forward to reviewing the full results from both species within the coming months.”

These two carcinogenicity studies are being carried out as part of the lanifibranor development plan and are a regulatory requirement for lanifibranor commercialization.

About lanifibranor:

Lanifibranor is a next generation pan-PPAR modulator designed as a moderately potent and well-balanced PPAR   and . This unique profile was conceived in order to obtain an optimal therapeutic margin with strong efficacy and tolerance. Lanifibranor displayed an antifibrotic efficacy superior to selective PPAR-α, PPAR-δ or PPAR- agonists in several relevant preclinical models. Inventiva is conducting two Phase IIb clinical studies in NASH and SSc with lanifibranor.

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

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.