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DewDiligence

05/13/15 10:33 AM

#191196 RE: DewDiligence #189933

GLMD -2% on slow recruitment in phase-2 gallstone trial:

http://finance.yahoo.com/news/galmed-pharmaceuticals-reports-first-quarter-110000821.html

…during the fourth quarter of 2014, we initiated a single-center, double blind, randomized Phase IIa placebo-controlled proof-of-concept clinical trial of aramchol in 36 patients for the treatment of newly formed cholesterol gallstones following bariatric surgery. Enrollment pace of the study has tracked significantly slower than anticipated. Therefore, the Company decided to expand the trial into 3 additional centers. Unfortunately, notwithstanding the significant efforts involved in the opening of the additional sites, enrollment has still continued to disappoint.

Consequently, we have filed a request with the principal investigator to cease enrollment in the underperforming center. Accordingly, the Company is taking this opportunity to reexamine the study design in order to achieve a better recruitment. We remain committed to the development for aramchol for cholesterol gallstones and hope to provide a revised strategy in the coming quarters.

Aramchol is also being tested in a phase-2b trial in NASH, which investors are more keenly following. In the NASH trial, interim data is expected in 1H16 and final data in late 2016.