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Friday, CymaBay Therapeutics Inc's (NASDAQ:CBAY) competitors Genfit SA (NASDAQ:GNFT) and Ipsen SA (OTC: IPSEY) announced topline results from the Phase III ELATIVE trial of elafibranorin primary biliary cholangitis (PBC).
The trial met its primary composite endpoint, with 51% of patients on elafibranor 80mg exhibiting a cholestasis response compared to 4% on placebo.
A significant improvement in the normalization of ALP at Week 52 was observed as the first secondary endpoint, indicating the efficacy of elafibranor.
While a trend towards pruritus (itching) improvement was observed, it did not reach statistical significance.
CymaBay's ongoing Phase 3 RESPONSE study is on track to release topline results in Q3. Management previously indicated that the study has sufficient power to capture the effect of pruritis reduction for those treated with seladelpar.
William Blair analyst is optimistic that seladelpar could show a statistically significant reduction in itch.
In the previous ENHANCE study, treatment with seladelpar led to a 1.59-point improvement (p=0.0165) for the 10 mg dose and a 0.46-point reduction for the 5 mg dose among those with moderate to severe itch at baseline.
At the European Association for the study of the Liver annual congress, CymaBay presented a poster that suggested treatment with seladelpar led to a dose-dependent reduction in interleukin-31, a validated "itch cytokine."
It notes that while the final arbiter will be the RESPONSE study results of seladelpar, a competitive overhang on the stock has been removed for Cymabay.
The analyst keeps an Outperform rating on CBAY stock.
Price Action: CBAY shares are up 41.6% at $11.10 on the last check Friday.
