Genfit: Risk of confusion between PPAR alpha/delta Phase 3 drug candidate elafibranor and PPAR a/d/gamma Phase 2 compound lanifibranor.
Genfit, a biopharmaceutical company developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases that notably affect the liver or the gastrointestinal system, alerts the public to the potential risk of confusion between Genfit’s drug candidate elafibranor currently evaluated in Phase 3 in NASH (INN granted by WHO in 2015, List 74) and Inventiva’s newly named Phase 2 compound lanifibranor (INN granted by WHO in September 2017, List 78).
The International Nonproprietary Name (INN) system provides health professionals with a unique and universal designated name for each pharmaceutical substance. This is an important reference for the clear identification of substances, as well as for safe prescription and dispensing of medicines to patients. In the INN system, the names of pharmacologically related substances have a common “stem,” enabling health professionals to recognize substances having similar pharmacological activity.
Elafibranor is a specific dual agonist of the PPAR alpha and PPAR delta isoforms, but is pharmacologically inactive on PPAR gamma, whereas lanifibranor is a PPAR alpha/delta/gamma. The suffix “-fibranor,” present in the names elafibranor and lanifibranor, is not a WHO-recognized INN stem. Healthcare professionals and patients could mistakenly assume that the two molecules have similar pharmacological activity. This may result in confusion and medication errors, particularly since both molecules are being developed for the same indication, nonalcoholic steatohepatitis (NASH).
It is important for future prescribers and patients to be able to distinguish molecules and mechanisms of action without any risk of confusion.
Elafibranor is now a well-established INN, thanks to an extensive amount of data gained through Phase 1, 2a and 2b clinical trials.
IVA-337 (newly granted INN lanifibranor) has not yet completed its Phase 2b trial and to date, no PPAR gamma compound has been able to demonstrate efficacy on resolution of NASH without worsening of fibrosis—based on the disappearance of ballooning and mild or no inflammation—without the known associated PPAR gamma side effects. PPAR gamma activity is therefore an important element of differentiation between PPAR compounds under development for NASH, and as such the similarity between the INN lanifibranor and the INN elafibranor is regrettable.
Elafibranor is Genfit’s lead pipeline product. Elafibranor is an oral once-daily administered molecule, and a first-in-class compound acting via dual peroxisome proliferator-activated alpha/delta pathways developed to treat, in particular, nonalcoholic steatohepatitis (NASH). Elafibranor is believed to address multiple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers.
“NASH”, or nonalcoholic steatohepatitis, is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. The disease is associated with long term risk of progression to cirrhosis, a state where liver function is diminished, leading to liver insufficiency, and also progression to liver cancer.
With facilities in Lille and Paris, France, and Cambridge, MA, the Genfit has approximately 130 employees. It is a public company listed in compartment B of Euronext’s regulated market in Paris (Euronext: GNFT – ISIN: FR0004163111).