Analysts tip Inventiva's lanifibranor as NASH blockbuster

Inventiva’s lanifibranor has been tipped to become a blockbuster in the fatty liver disease non-alcoholic steatohepatitis (NASH) after it became the first drug to hit two regulatory goals in a trial. 

In the phase 2b trial lanifibranor met twin endpoints relating to inflammation resolution and fibrosis (scarring) despite only six months’ treatment. 

The data prompted a team of analysts from Jefferies to raise peak sales predictions to $2.6 billion annually, adding that the data will help secure a partner or funds required to begin phase 3 development. 

In the NATIVE trial there were significant improvements with both the low 800 mg dose and high 1,200 mg doses producing significant improvements in NASH resolution without worsening of fibrosis compared with placebo. 

At low dose 33% of patients resolved NASH, compared with 45% at high dose, and 19% in the placebo group. 

In the phase 3 target population of people with F2-F3 disease, where the liver has become scarred, the treatment improvement was clearer, with 34% resolving symptoms at low dose, 44% at high dose, compared with 9% on placebo. 

At high dose there was a significant improvement of fibrosis by at least one stage without worsening of NASH in 42% of patients, and a trend to improvement at low dose where 28% of patients achieved this goal. 

The company plans meetings with regulators in the last quarter of this year, and assuming a standard phase 3 trial length, the drug could be launched in 2025 if trials are successful. 

Safety issues have proved to be a problem with dual panPARR agonists – but according to Jefferies the safety profile here is “broadly acceptable”. 

Rates of peripheral oedema were around 6% to 8.5%, lower than the 14%-23% reported for another PPAR drug, pioglitazone, although lanifibranor was also associated with similar levels of weight gain seen with pioglitazone. 

There are currently no approved drugs for NASH, also known as fatty liver disease, which pharma has targeted as a potential multi-billion dollar market. 

Intercept Pharmaceuticals’ obeticholic acid is closest to market but has faced several delays to its ongoing FDA review.

A regulatory decision was due at the end of this month, but the regulator has pushed this back asking for further data from Intercept. 

An expert advisory board meeting to discuss study findings slated for the beginning of the month has been cancelled, and the new target decision date has not been announced.