August 7, 2017
By Alex Keown, BioSpace.com Breaking News Staff
LIVONIA, Mich. – Shares of Gemphire Therapeutics have plunged more than 51 percent in morning trading after that company’s Phase IIb anti-cholesterol drug gemcabene failed to meet analyst expectations.
The bad news comes hard on the heels of the resignation of Mina Sooch, the company’s former chief executive officer, who abruptly left the company for personal reasons. Shares of Gemphire actually began to rise after Sooch’s resignation, climbing from $9.90 on May 31 to a high of $21.07 at the end of July. This morning though shares have dropped to $9.34 as of 10:52 a.m.
Gemphire said its Phase IIb Royal-1 trial of gemcabene met statistically significant endpoints, but that was below what analysts were expecting, Endpoints News reported this morning.
The Phase IIb trial included 105 patients who had a mean average age of 61 and whose LDL cholesterol levels were not controlled by statin and/or ezetimibe therapies. The primary endpoint was the percent change in LDL-C from baseline. Secondary endpoints included safety as well as the percent change from baseline in non-HDL-C, TC, TG, HDL-C, VLDL-C, Apo B, hsCRP and several other biomarkers. Patients were provided a 600 milligram dose of gemcabene. The mean baseline LDL-C was 130 mg/dL. Trial data shows 600 mg of gemcabene produced a mean percent change in LDL-C of -17.2 percent vs -5.5 percent for placebo. The 600 mg dosage of gemcabene produced a median percent change in hsCRP of -40.0 percent vs -6.1 percent for placebo.
“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,” Lee Golden, Gemphire’s chief medical officer, said in a statement. “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.”
Secondary results and subpopulations assessments will be provided once the full dataset has been analyzed.
While those endpoints were met, Endpoints News said the results were not what analysts were looking for, which is why company shares are falling this morning. Before Gemphire licensed the drug from Pfizer, the larger pharma company had been tracking reductions in LDL levels of 23 percent to 28 percent.
Gemphire said there were no serious adverse events in the study.
In June, Gemphire released data from its Phase IIb Cobalt-1 assessing gemcabene as a treatment for homozygous familial hypercholesterolemia (HoFH) patients. In that trial, gemcabene hit the mark. Data from that trial shows a 300 mg dose of gemcabene lowered LDL levels by 25 percent. The 600 milligram dose lowered LDL by 30 percent, the company said.
At the time the Cobalt-1 data was released, Steven Gullans, interim CEO of Gemphire Therapeutics, said gemcabene’s mean LDL-C reductions “compare favorably with the LDL-C reductions, generally 15-25 percent, observed for approved therapies to treat HoFH patients and are consistent with the LDL-C reductions seen in our prior hypercholesterolemia trials.”
