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.
周四,Gain Therapeutics, Inc.(纳斯达克:GANX)发布了第一阶段研究结果,评估了Gt-02287的安全性、耐受性和药动学。
The company previously announced that no discontinuations or serious adverse events were reported when the study concluded.
该公司先前宣布,当研究结束时,没有报告任何终止治疗或严重不良事件。
Also Read: EXCLUSIVE: Gain Therapeutics Highlights Lead Program Data Showcasing Its Impact On Cellular Death For Treating Parkinson's Disease.
同时阅读:独家:Gain Therapeutics强调了主导项目数据,展示其对治疗帕金森病的细胞死亡产生的影响。
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
第一阶段研究招募了72名健康志愿者。在数据库锁定后,对非盲数据的回顾确认,Gt-02287的单剂和多剂在所有年龄组的最高计划剂量范围内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出现在脑脊液中(CSF),并且已证明在外周靶点上发挥作用。
The favorable safety and tolerability profile at oral dose levels that resulted in therapeutic plasma levels, CNS exposure, and target engagement.
在产生治疗性血浆水平、中枢神经系统暴露和靶点作用的口服剂量水平上,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.
“在这些数据的基础上,我们预计将于2024年第四季度开始对帕金森病患者进行试验,以证明患有帕金森病的患者的安全性和耐受性,并根据相关生物标志物获得机制证据。我们预计在2025年中期获得来自帕金森病患者的数据,”Gain的首席医疗官Jonas Hannestad评论道。
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发布了临床前数据,证明其临床阶段GCase调节剂Gt-02287在延迟给药后对帕金森病模型提供了神经保护并恢复了运动功能。
Price Action: GANX stock is down 13.40% at $1.16 at the last check on Thursday.
股价走势:GANX股票在上周四最新检查时下跌13.40%,至1.16美元。
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来自Unsplash的Milad Fakurian的照片