GENFIT

Results from Ipsen’s ELATIVE pivotal Phase III trial of elafibranor in PBC presented as late breaking data at AASLD congress and published in New England Journal of Medicine - Seite 2

“When managing PBC, our first goal is to effectively control the disease progression which can lead to liver failure. The results from ELATIVE provide compelling evidence that elafibranor has the potential to achieve this goal, with evidence of a highly significant treatment benefit that is associated with improved clinical outcomes,” said Dr Christopher Bowlus, Professor of Gastroenterology and Hepatology, University of California Davis, U.S. “In addition, our patients need relief from the significant symptom burden of PBC, particularly those with moderate to severe itch. Data from ELATIVE demonstrated the possibility of improved pruritus for patients taking elafibranor compared with those on placebo. Taken together, these data suggest elafibranor could offer an effective new treatment opportunity for PBC management.”

ELATIVE investigated the effect of treatment with elafibranor on pruritus (severe itch) across three separate patient-reported outcome measures. On the key secondary endpoint using the PBC Worst Itch NRS score, the reduction of pruritus observed for elafibranor versus placebo was not statistically significant (LS mean, –1.93 versus –1.15; difference, –0.78; 95% CI, –1.99 to 0.42; P=0.20). Two other secondary patient-reported outcome measures were used to assess itch, and greater reductions in pruritus were observed with elafibranor compared with placebo at Week 52, according to the itch domain of PBC-40 quality of life questionnaire (LS mean difference -2.3; 95% CI, -4.0 to -0.7) and 5-D Itch total score (LS mean difference, -3.0; 95% CI, -5.5 to -0.5).

“We believe these data suggest that elafibranor could be a paradigm-changing treatment meeting the unmet need for an effective second-line option,” said Christelle Huguet, EVP and Head of Research and Development, Ipsen. “These data from ELATIVE have provided a better understanding of how we can effectively manage both disease progression and the symptom burden still experienced by many people living with PBC. It would not have been possible for us to investigate the potential for new innovative treatments without the involvement of the patients and their wider families and caregivers, to whom we are immensely grateful. We are also enormously grateful to the study investigators, who have supported us and provided us with the benefit of their expertise in designing and running this study.”