(News Bulletin 247) – The Genfit stock climbed by more than 20% on Friday and took the lead in the Paris market in the first exchanges following the publication of the encouraging results of a phase III clinical study.

The trial, conducted with its partner Ipsen on 161 patients, has indeed reached its evaluation criteria, with in particular a ‘statistically higher’ percentage of patients having observed a clinically significant evolution in primary biliary cholangitis (PBC), a disease rare liver cholestatic.

The study met its primary composite endpoint, with 51% of patients on elafibranor 80mg achieving improvement in cholestasis in response to treatment, compared with only 4% on placebo.

The secondary endpoint of normalization of alkaline phosphatase (ALP) levels at one year was also achieved with a statistically significant improvement in favor of elafibranor.

In addition, elafibranor was well tolerated with a consistent safety profile compared to previous studies, specifies the biotech.

From Genfit’s perspective, these results position elafibranor as an important new potential treatment option in areas where the need remains largely unmet.

Its partner Ipsen thus says it intends to submit authorization requests to the American (Food and Drug Administration) and European (European Medicines Agency) authorities.

According to analysts at Invest Securities, marketing approval could be granted in mid-2024, with commercialization likely to begin in the second half of 2024.

The design office recalls that the total PBC market is estimated at some 1.5 billion dollars by 2025, of which 515 million could be covered by elafibranor.

In total, over the commercial exclusivity period until 2035, Ipsen could thus generate nearly 3.85 billion dollars in revenue from product sales, knowing that Genfit is eligible for 20% royalties.

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