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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展示了一項臨床前研究結果,表明OV329與Vigabatrin相比不會在動物眼睛中積聚。
Benzinga ·  09/26 20:19
  • 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
  • 研究發現OV329在小鼠的視網膜、眼睛和腦組織中得到清除並保持不可檢測,不同於已經多次顯示偏向在小鼠視網膜、眼睛和其他組織中積累的維加巴林
  • OV329的效力、抑制機制、短半衰期、快速組織清除和持久的藥效效應表明,它提供了與維加巴林不同的眼部安全性和功效概況
  • 對健康志願者進行的一項評估OV329的1期試驗計劃在2024年底前完成,將評估安全性以及兩個靶位標和臨床效果的證據

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.

紐約,2024年9月26日(環球社)--Ovid Therapeutics Inc.(納斯達克股票代碼:OVID)是一家專注於改善罕見癲癇和腦部疾病患者生活質量的生物製藥公司,提出了一項針對OV329是否被發現在小鼠視網膜和腦中積累的頭對頭動物研究的結果,之前已經顯示維加巴林(VGB)是唯一獲得FDA批准的GABA-氨基轉移酶(GABA-AT)抑制劑也會發生這種情況

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.

這些發現通過在癲癇管道會議上的海報展示,發現OV329在連續暴露48小時後,通過皮下滲出泵清除並保持在小鼠的視網膜、眼睛和腦中不可檢測,表明沒有積累。相比之下,VGb在這段時間內確實發生了眼部積累。頭對頭動物研究的完整結果將於12月在2024年美國癲癇學會議上展示

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.

這些結果複製了先前發表的研究結果,顯示VGb偏好並快速在小鼠組織和血漿中積累,包括視網膜、視覺皮層和腦在亞療效劑量(70毫克/公斤)。與之相反,動物中的OV329治療劑量(5毫克/公斤)在同樣的研究設計中未顯示出眼部積累的跡象。這些結果和之前的研究相輔相成,顯示了動物中的治療劑量的OV329(3毫克/公斤)在斯普拉格達利大鼠中沒有在45天內導致視網膜組織病變,這是一種研究結構和功能性眼部毒性的動物模型。與之相反,VGb顯示了在300毫克/公斤的治療劑量下在45天內動物的視網膜細胞退化

譯文內容由第三人軟體翻譯。


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