CRO MMS supports Gemphire’s development of novel drug candidate in Ph IIb trial

Gemphire Therapeutics tapped the Canton, MI-based contract research organization (CRO) MMS Holdings to help support a Phase IIb clinical trial of its first-in-class drug candidate, Gemcabene.

Gemphire, headquartered in Livonia, MI, is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and nonalcoholic steatohepatitis (NASH).

The company recently announced that it has met primary and secondary endpoints in its Phase IIb INDIGO-1 clinical trial of Gemacabene – a first-in-class lipid-altering drug candidate – in patients with severe hypertriglyceridemia (SHTG).

As part of this, MMS Holdings (MMS) provided services globally from its various centers of excellence, including, biostatistics, clinical programming, data management, interactive response technology (IRT), pharmacovigilance, and medical writing.

“The flexibility and seamless working relationship between Gemphire and MMS has proven my confidence in our teams to be one step closer to bringing a product to market that can effectively reduce triglycerides in those that need it most,” said Dr. Uma Sharma, chief scientific officer, MMS, in a press release.

“The choice in collaborating with MMS to meet this milestone for the Phase IIb INDIGO-1 trial was simple, given their deep scientific knowledge and strategic resource models,” added Dr. Steven Gullans, CEO, Gemphire.