Galmed Pharmaceuticals in New York has signed an investigator-initiated clinical trial agreement with the Icahn School of Medicine at Mount Sinai in New York to evaluate the effect of aramchol in combination with vitamin D for treatment of nonalcoholic fatty liver disease, according to Street Insider.
The study, conducted under principal investigator Andrea Branch, PhD, professor of medicine at the Icahn School of Medicine at Mount Sinai, will enroll 80 patients with NAFLD and fibrosis and is anticipated to be completed in the first half of 2018. The study's four dose alternatives are aramchol, vitamin D, aramchol and vitamin D in combination and placebo, and will be administered for 24 weeks followed by a 4-week follow-up period.
Here are five points:
1. A recent study published in the American Journal of Gastroenterology found vitamin D deficiency contributes to increased oxidative stress, systemic inflammation, decreased adiponectin levels, toll-like receptor activation and NAFLD.
2. In the same study, vitamin D deficiency in the NAFLD subjects was associated with a definitive diagnosis of nonalcoholic steatohepatitis, increased lobular inflammation, more ballooning and the presence of fibrosis.
3. In addition to the dual therapy, Dr. Branch said the study will be open to patients with NASH and well-compensated liver cirrhosis, as well as to patients with less extensive liver damage, and it will not require a liver biopsy for participation.
4. Galmed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of a once-daily oral therapy for the treatment of liver diseases.
5. The Icahn School of Medicine at Mount Sinai is the medical school for the New York-based Mount Sinai Health System, which includes seven hospital campuses and has more than 5,000 faculty members and nearly 2,000 students, residents and fellows.