Galmed Pharma (GLMD) Announces a delay in the initiation of its Primary Sclerosing Cholangitis (PSC) Phase 2a Study

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases, announced today a delay of at least 6 months in the initiation of its Primary Sclerosing Cholangitis (PSC) Ph 2a Study.

In May 2023, Galmed announced the pivoting of its clinical program to evaluate the safety and efficacy of its lead compound, Aramchol meglumine, for the treatment PSC. All work was designed to ensure the initiation of a proof-of-concept Phase 2a study in the last quarter of 2023. Prior to the initiation of the Ph 2a study, Galmed had planned to complete a Ph1 pharmacokinetic (PK) study to determine the bioavailability of the newly improved Aramchol meglumine formulation and then submit a new IND application for Aramchol meglumine for PSC to the US FDA.

Due to the unexpected events of October 7th, Galmed no longer will be able to meet the original planned timelines of its Ph1 study. As new time estimates depend on timelines established by our US and European partners and vendors, Galmed currently estimates a delay of 6-9 months in the initiation of the Ph2a PSC Study.

Allen Baharaff, CEO and President of Galmed Pharmaceuticals commented " The brutal attack of Hamas on October 7^th resulted in a disruption of our work. Notwithstanding the Israel's declaration of "being at war", over the past few weeks we have been returning to full activity together with our local vendors and consultants. The unfortunate events result in delays which would prohibit us from meeting our original timelines. We are diligently working together with our local and international partners to mitigate the delays and will continue to update as soon as practical".

You May Also Be Interested In

• FDA Cautions Public of Safety Issue with Philips' (PHG) DreamStation 2 CPAP Machines
• Palvella Therapeutics and Ligand Pharmaceuticals (LGND) Expand Strategic Partnership to Accelerate Phase 3 Development of QTORIN
• Gain Therapeutics (GANX) Announces Preclinical Data Showing Restoration of Enzymatic Function with Novel Allosteric Regulators in GM1 Gangliosidosis Model