Inventiva's lanifibranor found to have good safety profile following first assessment of carcinogenicity studies' results

                                               
Inventiva's lanifibranor found to have good safety profile
following first assessment of carcinogenicity studies' results

• Two-year studies now completed confirming long-term safety of lanifibranor
• Both studies should be deemed adequate according to preliminary assessment

Results to be presented to FDA

Results to allow initiation of Phase III clinical trials  

Daix (France), August 13, 2018 - Inventiva, a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc), and mucopolysaccharidosis (MPS), today reported the successful completion of two two-year carcinogenicity studies with the pan-PPAR agonist lanifibranor.

A preliminary assessment was performed by Dr. Jeri El-Hage, toxicologist and regulatory consultant and expert in the PPAR field at Aclairo Pharmaceutical Development Group, indicating that both studies should be deemed adequate based on correct dosing and good tolerability.

"In my assessment of the results from the studies, it is clear that the toxicological profile of lanifibranor is relatively benign" said Dr. El-Hage. "The studies were well conducted with excellent survival rates and tolerability and results show an improved safety profile compared to other dual- and pan-PPARs. Lanifibranor displays a good cardiac safety profile and in my opinion the results of these studies should allow lanifibranor to enter into Phase III".

The two carcinogenicity studies in rats and in mice were initiated in October 2015 after study protocol approval by the US Food and Drug Administration (FDA). They were conducted by Envigo (United Kingdom), a Contract Research Organization (CRO) with expertise in running similar studies, particularly with compounds from the PPAR class. The studies assessed the effects of three doses of lanifibranor, administered daily for a 104-week period, compared to control groups.

The results of these studies will be presented to the FDA's Executive Carcinogenicity Assessment Committee (ECAC) in order to obtain the authorization to enter into Phase III. The special protocol assessments for the studies had been reviewed by the ECAC and the doses evaluated were approved for both studies.

"With the completion of these carcinogenicity studies, Inventiva has now finalized the regulatory toxicological package necessary to enter into Phase III with lanifibranor," declared Pierre Broqua, Chief Scientific Officer and co-founder of Inventiva. "The data demonstrate a good safety profile and we look forward to receiving feedback from the FDA in the coming months."