Cymabay soars as Genfit hits an itch hitch

The topline hit in the pivotal Elative study of Genfit’s elafibranor in primary biliary cholangitis means the company has salvaged something from the agent, which failed disastrously in Nash three years ago. It also validates Ipsen’s move to license the PPARα/δ agonist 18 months later. But the real winner might in fact be neither of these companies but Cymabay, developer of a similarly-acting agent. Cymabay’s stock opened up 40% today whereas Genfit’s shares sank 5% and Ipsen’s barely shifted, since the Elative data provide an opening for Cymabay’s seladelpar. Elative met its primary endpoint with a statistically significant difference in composite responders at one year – 51% versus 4% with placebo – but missed on the vital secondary of pruritus improvement, only mustering a favourable trend. It appears investors believe seladelpar can do better on the itch measure when its pivotal trial, Response, reports data in the coming quarter. And with reason: in seladelpar’s other phase 3 in primary biliary cholangitis, Enhance, 78% of patients on the 10mg dose achieved the composite response versus 13% on placebo at three months. Enhance also hit on pruritis, showing a significant 1.59-point improvement with the 10mg dose among those with moderate to severe itch at baseline.