A joint project between Hadassah-Hebrew University Medical Center and Brigham and Women’s Hospital/Harvard University (Boston) has achieved positive results in a Phase 2a clinical trial of a new oral immunotherapy, developed by NasVax, for an inflammatory condition associated with fatty liver disease and metabolic syndrome.
The trial was initiated in August 2010 and follows a successful Phase 1 clinical study in healthy subjects.The Phase 2a trial, conducted in the Liver Unit at Hadassah, investigated three dosage levels (0.2, 1.0, 5.0 mg) of anti-CD3 monoclonal antibody (MAb), given orally once daily for 30 days, with a final follow-up 30 days later (60 days after the first dose). Evaluations were for safety as primary endpoint, for immunological effects as co-primary endpoint, and for clinical biomarker effects as secondary endpoint. The trial was a single-blind randomized placebo-controlled study with 36 subjects, aged 18-75, who had non-alcoholic steatohepatitis (NASH), a severe form of fatty liver disease, and altered glucose metabolism. It also included subjects with type-2 diabetes.
The trial met all three endpoints: The researchers found reduced blood levels of two liver enzymes as markers for reduced liver inflammation, reduced blood levels of glucose, and improved performance in glucose tolerance testing, which are favorable outcomes for subjects with NASH or metabolic syndrome and for subjects with type-2 diabetes or altered glucose metabolism. Several of the positive efficacy trends generally persisted to Day 60, following cessation of immunotherapy at Day 30.