FDA clears aramchol IND application for HIV-related lipodystrophy, NAFLD

Galmed Pharmaceuticals announced the FDA has approved an investigational new drug application for their ARRIVE study, in which the safety and efficacy of aramchol among patients with HIV-associated lipodystrophy and nonalcoholic fatty liver disease will be evaluated.

The ARRIVE trial will be led by Rohit Loomba, MD, MHSc, director of the NAFLD Translational Research Unit, University of California San Diego, and include 50 patients with HIV-associated lipodystrophy and NAFLD who will be randomly assigned placebo or 600 mg of aramchol (Galmed Pharmaceuticals), a conjugate of cholic acid and arachidic acid, for 12 weeks. The primary endpoint of the research is improved hepatic steatosis as measured on MRI.

Rohit Loomba

“At the NAFLD Research Center, UCSD, our approach is to apply innovative clinical trial design by collaborating across disciplines to find solutions for clinical problems for patients suffering from liver diseases, and the ARRIVE Study is a prime example of this innovative team science approach as it brings together clinicians working on liver disease, MR imaging, body composition and HIV to help solve the understudied and underappreciated issue of HIV-associated NAFLD and lipodystrophy,” Loomba said in the press release.

In the release, Maya Halpern, MD, MA, chief medical officer at Galmed, discussed the absence of treatment for this population of patients: “Nearly half of the HIV infected patients without viral hepatitis that undergo evaluation for unexplained liver test abnormalities are found to have NAFLD. The prevalence of NAFLD is higher in individuals with HIV infection than in the general population. To date, there are no therapies for the treatment of HIV-associated NAFLD — like NASH — and clinical trials in this area have been few.”

The FDA granted fast track designation to aramchol in September 2014.

Disclosures: Halpern is employed by Galmed Pharmaceuticals.