Galmed Pharmaceuticals Provides Business Update and Reports Second Quarter 2020 Financial Results

About this update from Galmed Pharmaceuticals Ltd.

[{"type":"text","content":"Conference Call and Webcast Today at 8:30 a.m. ET / 5:30 a.m. PT\n\n\nTEL AVIV, Israel, Aug. 6, 2020 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (\"Galmed\" or the \"Company\"), a clinical-stage biopharmaceutical company focused on the development of the liver targeted SCD1 modulator Aramchol™, an oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH and fibrosis, provides today updated information on the Company's scientific and clinical development programs and reports financial results for the three and six months ended June 30, 2020. The Company will host a conference call and webcast at 08:30 ET today.\n\n \n \n \n \n \n \n\n \nRecent Clinical & Scientific Developments\nThe Data Monitoring Committee (DMC) of the ARMOR study held a scheduled meeting and recommended that the ARMOR Phase 3 trial for NASH and fibrosis can continue with no changes to the protocol. Galmed resumed recruitment in some of ARMOR study sites in the USA, Canada, France, Mexico, Chile, Spain, Belgium, Turkey and South Korea (one quarter earlier than previously anticipated). Galmed maintains its guidance for completion of recruitment of patients for the first part of the study by the fourth quarter of 2021 and reporting of top-line results for the first part of the study in the second half of 2023. Galmed continues to monitor the impact of the COVID-19 pandemic on its operations and is committed to ensuring the health, safety and well-being of its clinical study participants, staff at its study sites and employees. The rapid development and fluidity of the COVID-19 pandemic precludes any firm estimates as to the ultimate effect this disease will have on Galmed's clinical trials and is subject to change. Galmed intends to approach the regulatory agencies during the first quarter of 2021 to discuss its Aramchol Meglumine program. A preliminary bioequivalence (BE) study is planned for the third quarter of 2021 this year for identifying the equivalent dose to 300mg BID of aramchol acid, currently being used in the ARMOR study. This study is intended to serve as calibration for the regulatory BE study that Galmed plans on performing during the second quarter of 2021 with the identified Aramchol meglumine dose. Galmed is announcing phase 1 readiness of its pipeline program, Amilo-5MER. Amilo-5MER is being developed through a re...

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