IPSEF - Genfit soars 23% as Phase 3 trial for liver disease candidate succeeds
2023-06-30 06:58:14 ET
French biotech Genfit S.A. ( NASDAQ: GNFT ) added ~23% pre-market Friday after the company and its partner Ipsen ( OTCPK:IPSEY ) ( OTCPK:IPSEF ) announced that a Phase 3 trial for elafibranor targeted at the rare liver disease primary biliary cholangitis (PBC) reached the primary endpoint.
The pivotal study named Elative was designed to evaluate once-daily elafibranor at 80mg versus placebo in 161 patients with PBC who had an insufficient response or indicated intolerance to ursodeoxycholic acid (UDCA), the current standard of care.
As for the primary endpoint, 51% of patients on elafibranor indicated a statistically significant cholestasis response compared to 4% on placebo, according to topline data from Elative.
The trial also met the first secondary endpoint of normalization of the liver enzyme alkaline phosphatase.
However, the other secondary endpoint designed to measure the level of pruritus, a key symptom of PBC, didn’t indicate a statistically significant improvement.
According to the companies, the study drug was generally well tolerated, with a safety profile in line with its past studies.
Ipsen ( OTCPK:IPSEY ) plans to file regulatory applications for elafibranor with U.S. and EU regulators.
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Genfit soars 23% as Phase 3 trial for liver disease candidate succeeds