Treatment News

Galmed Announces ARRIVE Study Data

2.9 from 12 votes
Thursday, February 15, 2018

Learn more about:

Clinical Trials

EL AVIV, Israel - Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmedˮ or the "Company"), a clinical-stage biopharmaceutical company focused on the development of the liver targeted SCD1 modulator Aramchol, a once-daily, oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH and other liver diseases, announced top-line results from the ARRIVE Trial, which did not meet its primary endpoint.

ARRIVE, a Phase IIa, investigator initiated clinical trial conducted at the University of California San Diego by Professor Rohit Loomba was a randomized, double-blinded, placebo-controlled, 12 weeks, proof-of-concept study that evaluated the safety and efficacy of Aramchol at 600mg/day versus placebo in 50 patients with HIV-associated lipodystrophy and non-alcoholic fatty liver disease, or NAFLD. The primary endpoint of the study was improvement of liver fat at 12 weeks, as measured by MRI-PDFF. Liver biopsies were not included as part of the evaluation in this pilot trial.

The trial showed no difference between HIV patients receiving Aramchol™ for 12 weeks when compared with HIV patients in the placebo arm. Aramchol showed a favorable safety and tolerability profile. Further analysis of the data is ongoing.

Topline data from Galmed's Phase IIb ARREST study with 248 NASH patients assessing Aramchol™ 400 and 600mg/day following 52 weeks treatment, with endpoints measured by MRS and liver biopsies, is expected in Q2 2018.

Prof. Rohit Loomba, Principal Investigator of the ARRIVE study commented: "While further analysis is required, the results may mean that the pathogenesis of HIV-related NAFLD is likely different and potentially due to a complex mix of triggers that are both unique to HIV-associated NAFLD and may also have some shared pathways with primary NAFLD. The fatty liver disease in HIV lipodystrophy patients also has underlying fat destruction which may be different from the features that are seen in "garden variety NASH."

Allen Baharaff, Chief Executive Officer of Galmed, stated, "Aramchol, with its unique mechanism of action, favorable safety and tolerability profile, is being evaluated in a variety of liver diseases. Treating fatty liver disease, in the presence of the lipodystrophy associated with HIV and/or HIV therapy, may be more complex than treating fatty liver disease (NASH) in the non-HIV infected population. Prof. Loomba is a pioneer in this research for a well-deserved patient population. It will be important for researchers and companies to evaluate other therapeutic agents, alone or in combination, in the spectrum of fatty liver disease and lipodystrophy in the HIV infected population."

About Aramchol and Non-alcoholic Steatohepatitis (NASH)
Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol's ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating down regulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by down regulation of steatosis and directly on human collagen producing cells. Aramchol has been granted Fast Track designation status by the FDA for the treatment of NASH.

NASH is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplantation in the U.S. due to the rise in obesity. NASH is the progressive form of non-alcoholic fatty liver disease that can lead to cardiovascular disease, cirrhosis, liver cancer and end-stage liver disease related mortality.

About Galmed Pharmaceuticals Ltd.
Galmed is a clinical-stage biopharmaceutical company focused on the development of Aramchol, a first in class, novel, once-daily, oral therapy for the treatment of NASH for variable populations, as well as other liver associated disorders. Galmed is currently conducting the ARREST Study, a multicenter, randomized, double-blind, placebo-controlled Phase 2b clinical study designed to evaluate the efficacy and safety of Aramchol™ in subjects with NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic. More information about the ARREST Study may be found on identifier: NCT02279524.

Galmed Pharmaceuticals Ltd

Source: Galmed Pharmaceuticals Ltd.
2.9 from 12 votes
Free Newsletter
by Abidemi Uruejoma
by Abidemi Uruejoma
by Abidemi Uruejoma
by Abidemi Uruejoma