The Clinical Misjudgement
Gemphire (GEMP) is a clinical-stage biopharma that became a victim of its presumed success. It all started with its decision not to recognise its lead and sole investigative drug candidate, gemcabene, as a PPAR-? agonist. Despite the fact that gemcabene (formerly CI-1027 or PD 72953) was originally designated PPAR-? agonist by inventor, Pfizer (PFE), during its initial clinical development as a fibrate to improve dyslipidemia.
Gemphire presumed incorrectly that it could avoid the FDA mandated toxicology and carcinogenicity studies for “all” PPAR agonists in clinical trials longer than