TEL AVIV, Israel, Nov. 20, 2023 /PRNewswire/ -- 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 7th 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".
About Galmed Pharmaceuticals Ltd.
We are a clinical stage biopharmaceutical company focused on the development of Aramchol for liver and fibro-inflammatory diseases. We have focused almost exclusively on developing Aramchol for the treatment of NASH and are currently developing Aramchol for PSC and exploring the feasibility of developing Aramchol for other fibro-inflammatory indications outside of liver disease. We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide.
以色列特拉維夫，2023年11月20日 /PRNewswire/ —— 肝臟、代謝和纖維化疾病的臨床階段生物製藥公司高美製藥有限公司（納斯達克股票代碼：GLMD）（“Galmed” 或 “公司”）今天宣佈，其原發性硬化性膽管炎（PSC）Ph 2a研究的啓動時間至少延遲6個月。
2023年5月，Galmed宣佈調整其臨床計劃，以評估其用於治療PSC的先導化合物阿美霍爾葡甲胺的安全性和有效性。所有工作都旨在確保在2023年最後一個季度啓動概念驗證2a期研究。在Ph 2a研究啓動之前，Galmed曾計劃完成一項Ph1藥代動力學（PK）研究，以確定新改進的Aramchol葡甲胺配方的生物利用度，然後向美國食品藥品管理局提交新的用於PSC的Aramchol meglumine的IND申請。
由於10月7日發生的意外事件，Galmed將無法再按計劃完成其Ph1研究的時間表。由於新的時間估計取決於我們的美國和歐洲合作伙伴和供應商制定的時間表，Galmed目前估計，pH2a PSC研究的啓動將延遲6-9個月。
Galmed Pharmicals首席執行官兼總裁艾倫·巴哈拉夫評論說：“哈馬斯在10月7日的殘酷襲擊導致我們的工作中斷。儘管以色列宣佈 “處於戰爭狀態”，但在過去的幾周裏，我們與當地供應商和顧問一起恢復了全面的活動。不幸的事件導致了延誤，這將使我們無法按原定的時間表完成任務。我們正在努力與當地和國際合作夥伴合作，以減少延誤，並將繼續儘快進行更新。”
關於Galmed Pharmaceuticals 公司
我們是一家臨床階段的生物製藥公司，專注於開發用於肝臟和纖維炎症性疾病的Aramchol。我們幾乎完全專注於開發用於治療NASH的Aramchol，目前正在開發用於PSC的Aramchol，並正在探索開發用於肝臟疾病以外的其他纖維炎症適應症的阿美哲的可行性。我們還與希伯來大學合作開發了Amilo-5mer，這是一種 5 氨基酸的合成肽。
