Why Is Liver-Disease Drug Developer Hepion Pharmaceuticals Stock Trading Lower On Monday?
Why Is Liver-Disease Drug Developer Hepion Pharmaceuticals Stock Trading Lower On Monday?
Friday, Hepion Pharmaceuticals Inc. (NASDAQ:HEPA) said it has begun winding down activities in its ASCEND-NASH Trial while continuing to explore strategic alternatives, as announced in December 2023.
週五，Hepion Pharmicals Inc.（納斯達克股票代碼：HEPA）表示，正如2023年12月宣佈的那樣，它已開始結束其ASCEND-NASH試驗的活動，同時繼續探索戰略替代方案。
ASCEND-NASH is a Phase 2b, randomized, multicenter, double-blinded study with the first patient screened in August 2022 to evaluate the safety and efficacy of rencofilstat dosed for 12 months, with a target enrollment of 336 subjects.
ASCEND-NASH是一項2b期、隨機、多中心、雙盲研究，2022年8月對第一位患者進行了篩查，以評估爲期12個月的rencofilstat給藥的安全性和有效性，目標招募336名受試者。
Enrollment was paused in April 2023, with 151 subjects randomized. Approximately 80 subjects have completed their Day 365 visits and are evaluated for safety and efficacy.
入學於 2023 年 4 月暫停，隨機分配了 151 名受試者。大約80名受試者已經完成了365天的就診，並接受了安全性和有效性評估。
An additional 40 subjects will provide significant safety data for evaluation. These patients will be added to our existing safety database.
另外40名受試者將爲評估提供重要的安全數據。這些患者將被添加到我們現有的安全數據庫中。
"We are disappointed to announce the wind-down of our Phase 2 NASH trial, which we attribute entirely to resource constraints," said John Brancaccio, Executive Chairman of Hepion.
Hepion執行董事長約翰·布蘭卡喬說：“我們失望地宣佈我們的第二階段NASH試驗結束，這完全歸因於資源限制。”
"Given the number of enrolled NASH patients to date and the low probability of generating relevant efficacy data to support a registrational trial with our current cash resources, we have opted to wind down the program and assure that patients are transitioned out of the trial in a safe and compliant manner. There were no safety concerns observed for rencofilstat in the ASCEND-NASH trial."
“鑑於迄今爲止註冊的NASH患者數量衆多，而且用我們目前的現金資源生成相關療效數據以支持註冊試驗的可能性很小，我們選擇結束該計劃，並確保患者以安全和合規的方式過渡出試驗。在ASCEND-NASH試驗中，沒有發現rencofilstat的安全問題。”
Price Action: HEPA shares are down 28.5% at $1.44 at the last check Monday.
價格走勢：在週一的最後一次檢查中，HEPA股價下跌28.5％，至1.44美元。
Photo via Shutterstock
照片來自 Shutterstock
譯文內容由第三人軟體翻譯。