Drug Development

CymaBay shares get a bounce on positive PBC PhII data

Gideon Hirschfeld

CymaBay Therapeutics got a badly needed boost this morning after its lead drug scored some positive data in a Phase II trial.

The Newark, CA-based biotech — the old Metabolex, which has had its share of ups and downs over the years — says two doses of saledelpar demonstrated an ability to slash levels of alkaline phosphatase among treatment-resistant patients suffering from primary biliary cholangitis. The 5 mg and 10 mg doses cut AP levels by 39% and 45% from baseline after 12 weeks of therapy.

That’s what investors wanted to hear. The stock $CBAY shot up 23% on the news of this drug, which still has a considerable clinical pathway ahead.

Not only were there no serious adverse events in the study — a key consideration given the target — investigators reported that transaminase levels dropped. Liver markers of cholestasis — including gamma glutamyl transferase and total bilirubin — were also improved, according to the company. And there was no evidence of drug-induced itching, or pruritis.

CymaBay floated its IPO back in 2014, after the company — as Metabolex — had burned through $349 million and watched Sanofi punt a big partnership in 2011. Since then it’s been doing a considerable amount of reorganizing.

“The data emerging from this study are impressive and support our hypothesis that lower doses of seladelpar than previously studied retain strong efficacy without raising a concern with transaminase elevations. We also see that seladelpar activity is not associated with drug-induced itch, an important benefit for patients with PBC. If these results are maintained over longer periods, we think that seladelpar could offer patients significant advantages over existing treatments,” said Gideon Hirschfeld of the Centre for Liver Research, University of Birmingham, UK.


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