Actions of Genfit (NASDAQ: GNFT) soared 25% higher at 11:58 a.m. EST Wednesday. The big leap came after the company announced positive results from a Phase 2 study evaluating elafibranor for the treatment of primary biliary cholangitis (PBC), an autoimmune disease that causes scarring of the bile ducts in the liver. .
The results of phase 2 of Genfit, published in the Journal of hepatology, showed that elafibranor met the primary endpoint of the study of reducing alkaline phosphatase (ALP) in patients with PBC who were previously taking ursodeoxycholic acid (UDCA) for their disease . ALP levels are a key measure in determining the severity of liver disease. The data also indicated that elafibranor was generally well tolerated.
Although there are approved PBC therapies on the market (including UDCA), many patients do not benefit much from these existing drugs. The latest clinical results from Genfit may increase the chances that elafibranor will become another important treatment for PBC.
The drugmaker launched a pivotal Phase 3 study of elafibranor for the treatment of PBC in September 2020. Carol Addy, Chief Medical Officer of Genfit, said the results announced today “confirm the rationale for the evaluation of our compound in this disease. [PBC] in a pivotal phase 3 trial. “
It may take some time for the biotechnology stocks benefits from another catalyst linked to the PBC indication. Genefit does not expect to release the first data from its pivotal, advanced study of elafibranor as a second-line treatment for PBC until Q1 2023.
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