Maxim Group downgraded Galmed Pharmaceuticals (NASDAQ:GLMD) to “hold” from “buy” and removed its previous $14 price target after the company announced that top-line results from the ARRIVE trial did not meet its primary endpoint.
Shares of Galmed were quoted at $4.23, down $5.23, in early trading on Feb. 14.
Analyst Jason Kolbert writes the investigator-led, Phase 2a study was randomized, double-blinded, and placebo-controlled. The study treated patients for 12 weeks.
The goal was to establish proof-of-concept for Aramchol at 600 mg/day versus placebo in 50 patients with HIV-associated lipodystrophy and non-alcoholic fatty liver disease. The primary endpoint of the study was improvement of liver fat at 12 weeks.
Mr. Kolbert said the trial showed no difference between HIV patients receiving Aramchol for 12 weeks, compared with HIV patients in the placebo arm. Aramchol showed a favorable safety and tolerability profile.
Top-line data from Galmed’s Phase 2b ARREST study with 248 NASH patients assessing Aramchol 400 and 600 mg/day following 52 weeks treatment, with endpoints measured by MRS and liver biopsies, is expected in the second quarter of 2018. This will be the next major event for the company, he added.
