Biotech Values

[DewDiligence]

GLMD -47% on phase-2 failure in ARRIVE study:

https://finance.yahoo.com/news/galmed-announces-arrive-study-data-120000414.html

Galmed Pharmaceuticals…a clinical-stage biopharmaceutical company focused on the development of the liver targeted SCD1 modulator Aramchol…for the treatment of nonalcoholic steatohepatitis, or NASH and other liver diseases, announced today 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…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. The primary endpoint of the study was improvement of liver fat at 12 weeks, as measured by MRI-PDFF.

The trial showed no difference between HIV patients receiving Aramchol for 12 weeks when compared with HIV patients in the placebo arm. Further analysis of the data is ongoing.

ARIIVE should not be confused with ARREST, GLMD’s own phase-2b trial of NASH patients, where data are expected in 2Q18.

Today’s severe sell-off is an indication that investors think Aramchol doesn’t work, period.