Inventiva rises as liver fat falls

Expectations for Nash and fatty liver are such that even a middling showing in an academic-led study can boost a stock. Today’s beneficiary is Inventiva, up 25% thanks to data on the PPAR agonist lanifibranor in patients with type 2 diabetes and nonalcoholic fatty liver disease. In the trial, conducted by researchers from the University of Florida, lanifibranor reduced intrahepatic triglycerides over placebo after six months, hitting the primary goal. Inventiva released the comparison slide below, but the lanifibranor data here came from just 28 completers; in addition, adjusting for placebo shows lanifibranor only managed to outdo 24-week data on Novo Nordisk’s semaglutide. Still, semaglutide’s effect deepened over time, so perhaps lanifibranor’s will too. The project was largely safe though Inventiva today disclosed that lanifibranor patients gained an average of 2.5kg, while those in the placebo group lost 1kg. The group said this was similar to what was seen in the earlier, successful Native trial in Nash. In the ongoing phase 2 Legend trial in Nash and diabetes, lanifibranor is being combined with SGLT2 inhibitors, which might mitigate this side effect. Data from the pivotal Nativ3 trial in Nash are not expected until 2025. 

Data from Ph2 academic trial of lanifibranor (NCT03459079)
Liver fat endpoints - full analysis
  Lanifibranor 800mg Placebo p value 
N 20 18 -
Primary endpoint: change in IHTG* -44% points -12% points 0.002
Proportion of patients with >30% liver fat reduction* 65% 22% 0.008
Proportion of patients with NAFLD resolution (defined as IHTG ≤ 5.5%)** 25% 0% 0.048
Liver fat endpoints - completers analysis
N 14 14 -
Change in IHTG* -50% points -16% points 0.002
IHTG=intrahepatic triglycerides. All data at wk24. *Missing data at wk24 were imputed by baseline data. **Missing data at wk24 were imputed as non-responders. Source: company release.
Source: company presentation.

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