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Ovid Therapeutics Presents Pre-Clinical Study Results Demonstrating OV329 Does Not Accumulate In Animal Eyes in Contrast With Vigabatrin

Ovid Therapeutics Presents Pre-Clinical Study Results Demonstrating OV329 Does Not Accumulate In Animal Eyes in Contrast With Vigabatrin

ovid therapeutics展示了一项临床前研究结果,表明OV329与Vigabatrin相比不会在动物眼睛中积聚。
Benzinga ·  09/26 08:19
  • Study found OV329 cleared and remained undetectable in the retina, eye, and brain tissues of mice, unlike vigabatrin which has repeatedly shown to preferentially accumulate in mouse retinas, eyes, and other tissues
  • OV329's potency, mechanism of inhibition, short half-life, rapid tissue elimination and prolonged pharmacodynamic effect suggests it delivers a differentiated ocular safety and efficacy profile from vigabatrin
  • A Phase 1 trial evaluating OV329 in healthy volunteers is on-track for completion in late 2024 and will evaluate safety and two biomarkers for target engagement and evidence of clinical effect
  • 研究发现OV329在小鼠的视网膜、眼睛和脑组织中得到清除并保持不可检测,不同于已经多次显示偏向在小鼠视网膜、眼睛和其他组织中积累的维加巴林
  • OV329的效力、抑制机制、短半衰期、快速组织清除和持久的药效效应表明,它提供了与维加巴林不同的眼部安全性和功效概况
  • 对健康志愿者进行的一项评估OV329的1期试验计划在2024年底前完成,将评估安全性以及两个靶位标和临床效果的证据

NEW YORK, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ:OVID), a biopharmaceutical company dedicated to improving the lives of people affected by rare epilepsies and brain conditions presented the results of a head-to-head animal study evaluating whether OV329 could be found to accumulate in mouse retinas and brains, as has been previously shown to occur with vigabatrin (VGB) the only FDA-approved GABA-aminotransferase (GABA-AT) inhibitor.

纽约,2024年9月26日(环球社)--Ovid Therapeutics Inc.(纳斯达克股票代码:OVID)是一家专注于改善罕见癫痫和脑部疾病患者生活质量的生物制药公司,提出了一项针对OV329是否被发现在小鼠视网膜和脑中积累的头对头动物研究的结果,之前已经显示维加巴林(VGB)是唯一获得FDA批准的GABA-氨基转移酶(GABA-AT)抑制剂也会发生这种情况

The findings, which were presented via a poster at the Epilepsy Pipeline Conference, found that OV329 cleared and remained undetectable in the retinas, eyes, and brains of mice after 48 hours of continuous exposure via a sub-cutaneous osmotic pump, suggesting a lack of accumulation. In contrast, ocular accumulation of VGB was confirmed within this period. Full results from the head-to-head animal study will be presented at the 2024 American Epilepsy Society conference in December.

这些发现通过在癫痫管道会议上的海报展示,发现OV329在连续暴露48小时后,通过皮下渗出泵清除并保持在小鼠的视网膜、眼睛和脑中不可检测,表明没有积累。相比之下,VGb在这段时间内确实发生了眼部积累。头对头动物研究的完整结果将于12月在2024年美国癫痫学会议上展示

These results replicate previously published findings that indicate VGB preferentially and rapidly accumulates within mouse tissue and plasma, including retina, visual cortex, and brain at subtherapeutic doses (70 mg/kg).1,2 In contrast, a therapeutic dose of OV329 in animals (5 mg/kg) did not show signs of ocular accumulation in the same study design. These results complement previously presented studies which showed that therapeutic doses of OV329 (3 mg/kg) did not result in retinal tissue pathology at 45 days in Sprague Dawley rats, an animal model that investigates structural and functional ocular toxicity.3 In contrast, VGB did show retinal cell degradation at the therapeutic dose in animals of 300 mg/kg at 45 days.

这些结果复制了先前发表的研究结果,显示VGb偏好并快速在小鼠组织和血浆中积累,包括视网膜、视觉皮层和脑在亚疗效剂量(70毫克/公斤)。与之相反,动物中的OV329治疗剂量(5毫克/公斤)在同样的研究设计中未显示出眼部积累的迹象。这些结果和之前的研究相辅相成,显示了动物中的治疗剂量的OV329(3毫克/公斤)在斯普拉格达利大鼠中没有在45天内导致视网膜组织病变,这是一种研究结构和功能性眼部毒性的动物模型。与之相反,VGb显示了在300毫克/公斤的治疗剂量下在45天内动物的视网膜细胞退化

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