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Gemphire shares crater after its LDL drug comes up short in PhIIb

Lee Golden, Gemphire CMO

Just two months after Gemphire $GEMP CEO Mina Sooch abruptly left the helm, the biotech is reporting out some disappointing new LDL data from a Phase IIb study of their lead drug.

After enrolling 105 men and women whose LDL was not controlled by statins for its ROYAL-1 study, investigators reported tracking a 17% reduction in bad LDL levels among patients taking gemcabene, significantly less than the 23% to 28% reductions that Pfizer had been tracking before outlicensing the drug to the Livonia, MI-based company.

That hit the mark for statistical significance but missed the target analysts have been eyeing. That will likely heighten the disappointment the company has stirred up after its IPO one year ago also left backers assessing the shortfall.

Gemphire’s stock crashed, dropping 47%.

“In ROYAL-1, gemcabene met the primary endpoint and demonstrated a statistically significant lowering in LDL-C, although the magnitude of LDL-C lowering was less than observed in certain prior studies of gemcabene,” stated Lee Golden, Gemphire’s CMO.  “The company will perform additional analyses to thoroughly evaluate the results of the trial.  Once the additional analyses are complete, we will provide an update.”

The drug did better in the COBALT-1 study among  homozygous familial hypercholesterolemia patients, out a bit more than a month ago, adding gemcabene to a variety of lipid-lowering drugs in use.

The drug was snagged from Pfizer by Gemphire CSO Charles Bisgaier and chief legal officer David Lowenschuss.


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