Galmed Pharmaceuticals announced that it will use EndoPAT technology in a phase 2b clinical trial to test aramchol for the treatment of nonalcoholic steatohepatitis, according to a news release.
Galmed purchased 60 EndoPAT (Itamar Medical) devices and accessories that it will use to determine endothelial function among NASH patients in the trial, the release said.
“The collaboration with Itamar Medical will allow Galmed to further its understanding of aramchol’s effect on endothelial function, which may be impaired in NASH patients,” Allen Baharaff, chief executive officer of Galmed, said in the release. “If our planned phase 2b trial confirms aramchol’s effect on endothelial function in NASH patients, we believe that EndoPAT could potentially be used by physicians in outpatient clinics as a noninvasive test for aramchol’s effect on vascular function.”
Previously Galmed announced the trial will commence later this year and include 240 patients with NASH as well as obesity and insulin resistance from Israel, Europe and Latin America. In a phase 2a clinical trial, 300 mg aramchol effectively reduced liver fat when taken once daily for 3 months.
“We are proud of this collaboration and excited that Galmed has chosen to use Itamar Medical’s technology as a marker of cardiovascular risk in a large-scale clinical trial,” Gilad Glick, chief executive officer of Itamar Medical, said in the release.
The FDA granted fast track designation to aramchol, a conjugate of cholic acid and arachidic acid, earlier this month.