GENFIT has started the phase 3 ELATIVE clinical trial for evaluating the efficacy and safety of elafibranor for the treatment of primary biliary cholangitis (PBC).
According to the French pharma company, ELATIVE is a randomized, double blind, placebo-controlled, global multicenter phase 3 study.
Elafibranor is a dual PPAR alpha and delta agonist in primary biliary cholangitis, which is a severe cholestatic liver disease.
The primary endpoint of the ELATIVE clinical trial will assess the response to treatment defined by alkaline phosphatase (ALP) lesser than 1.67 x upper limit of normal (ULN), total bilirubin (TB) ≤ ULN and ALP decrease ≥ 15%.
Key secondary endpoints of the late-stage clinical trial will include the effect of elafibranor on normalization of ALP and variation in pruritus from baseline.
The randomized study will evaluate elafibranor against placebo in nearly 150 patients who have inadequate response to ursodeoxycholic acid (UDCA) after 52 weeks of treatment. The patients will be randomly grouped in a ratio of 2:1 elafibranor:placebo.
Pascal Prigent – CEO at GENFIT said: “I am proud of the GENFIT team, who have worked hard to achieve the first patient first visit for ELATIVE amidst the ongoing challenges presented by the COVID-19 global pandemic. This is a significant milestone and it means that we are now a step closer to hopefully bringing patients and caregivers a promising option to treat this debilitating disease and its symptoms.
“We see an important potential for elafibranor in PBC and will provide further information at the upcoming Corporate Update on September 30.”
In 2018, GENFIT reported positive data from a phase 2 clinical trial in primary biliary cholangitis, where elafibranor demonstrated a clinically relevant improvement on the primary and composite biochemical endpoints.
The dual PPAR alpha and delta agonist provided early confirmation of efficacy, a positive trend on pruritus improvement, while sustaining a favorable tolerability profile. Based on these findings, elafibranor was given breakthrough therapy designation from the US Food and Drug Administration (FDA), and also orphan drug designation from the same regulator and also the European Medicines Agency (EMA).