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
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 groupsThursday, 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：GANX）發佈了第一階段研究結果，評估了Gt-02287的安全性、耐受性和藥動學。
The company previously announced that no discontinuations or serious adverse events were reported when the study concluded.
該公司先前宣佈，當研究結束時，沒有報告任何終止治療或嚴重不良事件。
Also Read: EXCLUSIVE: Gain Therapeutics Highlights Lead Program Data Showcasing Its Impact On Cellular Death For Treating Parkinson's Disease.
同時閱讀：獨家：Gain Therapeutics強調了主導項目數據，展示其對治療帕金森病的細胞死亡產生的影響。
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
第一階段研究招募了72名健康志願者。在數據庫鎖定後，對非盲數據的回顧確認，Gt-02287的單劑和多劑在所有年齡組的最高計劃劑量範圍內都是安全和一般耐受的。
GT-02287 was present in the cerebrospinal fluid (CSF), and peripheral target engagement was demonstrated.
Gt-02287出現在腦脊液中（CSF），並且已證明在外周靶點上發揮作用。
The favorable safety and tolerability profile at oral dose levels that resulted in therapeutic plasma levels, CNS exposure, and target engagement.
在產生治療性血漿水平、中樞神經系統暴露和靶點作用的口服劑量水平上，具有良好的安全性和耐受性。
"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.
「在這些數據的基礎上，我們預計將於2024年第四季度開始對帕金森病患者進行試驗，以證明患有帕金森病的患者的安全性和耐受性，並根據相關生物標誌物獲得機制證據。我們預計在2025年中期獲得來自帕金森病患者的數據，」Gain的首席醫療官Jonas Hannestad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.
今年二月，Gain Therapeutics發佈了臨床前數據，證明其臨床階段GCase調節劑Gt-02287在延遲給藥後對帕金森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.
股價走勢：GANX股票在上週四最新檢查時下跌13.40％，至1.16美元。
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Photo by Milad Fakurian on Unsplash
來自Unsplash的Milad Fakurian的照片
譯文內容由第三人軟體翻譯。