DMT's Clinical Path For Treating TBI And Stroke: Phase 1 Dosing Finished As Phase 2 Gears Up
DMT's Clinical Path For Treating TBI And Stroke: Phase 1 Dosing Finished As Phase 2 Gears Up
Algernon Pharmaceuticals' (OTCQB:AGNPF) wholly-owned Algernon NeuroScience (AGN Neuro) successfully completed dosing the third and final cohort of its Phase 1 clinical study assessing an intravenous (IV) formulation of the company's DMT compound, AP-188, aiming to treat both stroke and Traumatic Brain Injury (TBI.)
阿爾傑農製藥公司(OTCQB：AGNPF)全資擁有的Algernon Neuro(AGN Neuro)成功地完成了其第一階段臨床研究的第三個也是最後一個隊列的劑量，評估該公司的DMT化合物AP-188的靜脈(IV)配方，旨在治療中風和創傷性腦損傷(TBI)。
The study, conducted at the CHDR in the Netherlands, is set to test DMT's safety, tolerability and pharmacokinetics (PK) at single-escalating, sub-psychedelic concentrations through a 6-hour long IV infusion.
這項研究在荷蘭的CHDR進行，旨在通過長達6小時的靜脈輸注測試DMT的安全性、耐受性和藥代動力學(PK)，在單級遞增的亞迷幻濃度下。
The trial's safety review committee confirmed there were no safety or tolerability issues with the highest dose, which was able to maintain plasma DMT concentrations at targeted levels while being below the established psychedelic dose, equivalent to 0.2 mg/kg according to Dr. Rick Strassman, DMT researcher and the company's consultant.
該試驗的安全審查委員會證實，最高劑量沒有安全或耐受性問題，能夠將血漿DMT濃度維持在目標水準，同時低於既定的迷幻劑量，相當於0.2毫克/公斤裡克·斯特拉斯曼博士、DMT研究員和該公司的顧問。
Based on the positive delivery of the highest dose tested, the next study will include dosing subjects for six hours with multiple administrations, over a two-week period. The company would use its new single-dose regimen in an upcoming Phase 2 study on patients with stroke and TBI.
根據測試的最高劑量的陽性結果，下一項研究將包括在兩周內多次給藥，給受試者6小時的劑量。該公司將在即將到來的針對中風和腦外傷患者的第二階段研究中使用其新的單劑療法。
DMT's Relation To TBI And Stroke
DMT與顱腦損傷及卒中的關係
DMT, an agonist of multiple receptors including serotonin and sigma-1 -a receptor that responds to stress and is responsible for promoting cell survival, neuroprotection, neuroplasticity and neuroimmunomodulation, would also promote the release of Brain-Derived Neurotrophic Factor (BDNF), a protein believed to help in recovery after a brain injury.
DMT是一種多種受體的激動劑，包括5-羥色胺和sigma-1受體，它對壓力做出反應，負責促進細胞存活、神經保護、神經可塑性和神經免疫調節，還將促進腦源性神經營養因數(BDNF)的釋放，這是一種被認為有助於腦損傷後恢復的蛋白質。
Algernon's CEO Christopher Moreau explained that neuroplasticity's role in healing the brain after an injury is "one of the most exciting areas of research going on globally in the pursuit of a treatment for stroke and TBI."
Algernon的首席執行官克裡斯托弗·莫羅他解釋說，神經可塑性在損傷後修復大腦中的作用是“全球正在進行的研究中最令人興奮的領域之一，目的是尋求中風和腦外傷的治療方法。”
At high doses, DMT shows a rapid onset, intense psychedelic effects and a relatively short action duration.
高劑量時，DMT起效快，致幻作用強烈，作用持續時間較短。
At non-hallucinogenic doses, DMT has preclinically been shown to induce and improve structural and functional neuroplasticity by activating pathways involved in forming neuronal connections and increasing the number of dendritic spines, which in turn connect with other neurons and are a critical site of molecular brain activity.
在非致幻劑量下，DMT已被臨床前證明通過激活參與形成神經元連接的通路和增加樹突棘的數量來誘導和改善結構和功能的可塑性，樹突棘反過來與其他神經元連接，是分子腦活動的關鍵部位。
"Now that we have established the safety of a single sub-psychedelic dose of DMT, we are planning to accelerate our DMT Phase 2 studies accordingly, for both stroke and TBI," said Moreau.
“既然我們已經確定了單一亞迷幻劑量的DMT的安全性，我們正計劃相應地加快我們的DMT第二階段研究，對中風和腦外傷都是如此，”Moreau說。
Photo by Robina Weermeijer on Unsplash
Robina Weermeijer在Unspash上的照片
譯文內容由第三人軟體翻譯。