Small-Cap Gain Therapeutics Stock Falls On Phase 1 Data From Its Lead Asset For Parkinson's Disease
Small-Cap Gain Therapeutics Stock Falls On Phase 1 Data From Its Lead Asset For Parkinson's Disease
Thursday, Gain Therapeutics, Inc. (NASDAQ:GANX) released results from the Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of GT-02287.
週四，Gain Therapeutics, Inc.（納斯達克股票代碼：GANX）公佈了評估Gt-02287的安全性、耐受性和藥代動力學的1期研究結果。
The company previously announced that no discontinuations or serious adverse events were reported when the study concluded.
該公司此前宣佈，研究結束時沒有報告停藥或出現嚴重不良事件。
Also Read: EXCLUSIVE: Gain Therapeutics Highlights Lead Program Data Showcasing Its Impact On Cellular Death For Treating Parkinson's Disease.
另請閱讀：獨家：Gain Therapeutics重點介紹主要項目數據，這些數據顯示了其對治療帕金森氏病的細胞死亡的影響。
The Phase 1 study enrolled 72 healthy volunteers. A review of unblinded data after database lock confirmed that single and multiple doses of GT-02287 were safe and generally well tolerated up to and including the highest planned dose levels across all age groups
第一階段研究招收了72名健康志願者。數據庫鎖定後對非盲數據的審查證實，單劑量和多劑Gt-02287是安全的，總體耐受性良好，最高可達幷包括所有年齡組中最高的計劃劑量水平
GT-02287 was present in the cerebrospinal fluid (CSF), and peripheral target engagement was demonstrated.
Gt-02287存在於腦脊液（CSF）中，並證實了外周靶標的接合。
The favorable safety and tolerability profile at oral dose levels that resulted in therapeutic plasma levels, CNS exposure, and target engagement.
口服劑量水平具有良好的安全性和耐受性，可提高治療性血漿水平、中樞神經系統暴露和靶標參與度。
"On the heels of this data, we expect to initiate a trial in people with Parkinson's disease by Q4 2024 with the goal of demonstrating safety and tolerability in patients with Parkinson's disease and to obtain proof of mechanism based on relevant biomarkers. We anticipate having data from Parkinson's disease patients by mid-point 2025," commented Jonas Hannestad, Chief Medical Officer of Gain.
「根據這些數據，我們預計將在2024年第四季度之前啓動一項針對帕金森氏病患者的試驗，目的是證明帕金森氏病患者的安全性和耐受性，並獲得基於相關生物標誌物的機制證據。我們預計，到2025年中點，我們將獲得帕金森氏病患者的數據。」 Gain首席醫學官喬納斯·漢內斯塔德評論道。
In February, Gain Therapeutics released preclinical data demonstrating that its clinical-stage GCase regulator GT-02287 provided neuroprotection and restored motor function in Parkinson's disease models following delayed administration.
2月，Gain Therapeutics發佈了臨床前數據，表明其臨床階段的GCase調節劑Gt-02287在延遲給藥後爲帕金森氏病模型提供了神經保護並恢復了運動功能。
Price Action: GANX stock is down 13.40% at $1.16 at the last check on Thursday.
價格走勢：週四最後一次支票時，GANX股價下跌13.40％，至1.16美元。
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Photo by Milad Fakurian on Unsplash
照片由 Milad Fakurian 在 Unsplash 上拍攝