Canadian biopharma company Algernon Pharmaceuticals Inc. (OTCQB:AGNPF)'s subsidiary Algernon NeuroScience (AGN Neuro) completed dosing the second cohort of its Phase 1 study on the company's proprietary IV formulation of DMT, AP-188. It is now moving forward with the final cohort at an escalated dose after no safety or tolerability issues were found.
The trial, conducted at the Centre for Human Drug Research (CHDR) in the Netherlands, aims to identify the safety, tolerability and pharmacokinetics of the hallucinogenic tryptamine drug administered as an IV bolus followed by a prolonged infusion of 6 hours.
After establishing the correct dose and optimum exposure period in the first part of the study, the second part will include dosing subjects for six hours with repeated dosing over a two-week period.
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Phase 2 study design is also underway. Led by Algernon's stroke and traumatic brain injury (TBI) experts, the next-stage trial would assess DMT therapy's effects on patients with serious brain injuries.
Algernon has filed patents for novel salt forms of DMT (pamoate and nicotinate) as well as claims on formulation, dosage and usage methods for ischemic stroke and the combination therapy of DMT and stroke rehabilitation, including Constraint Induced Movement Therapy.
The company is supplying Yale University with its psychedelic compound for an investigator-initiated clinical trial assessing multiple IV doses of DMT for the treatment of depression.
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加拿大生物製藥公司Algernon PharmPharmticals Inc.(OTCQB:AGNPF)的子公司Algernon Neuro(AGN Neuro)完成了對該公司專有的DMT IV配方AP-188進行的第一階段研究的第二組劑量。在沒有發現安全性或耐受性問題後,該公司現在正在以更高的劑量進行最後一組試驗。
這項試驗在荷蘭的人類藥物研究中心(CHDR)進行,旨在確定致幻色胺藥物的安全性、耐受性和藥代動力學,以靜脈推注的形式給藥,然後長時間輸注6小時。
在第一部分確定了正確的劑量和最佳暴露時間後,第二部分將包括在兩周內重複給藥,給受試者服用六個小時的劑量。
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第二階段的研究設計也在進行中。由Algernon的中風和創傷性腦損傷(TBI)專家領導的下一階段試驗將評估DMT療法對嚴重腦損傷患者的效果。
Algernon已經為新型鹽形式的DMT(帕莫酸鹽和尼古丁)申請了專利,並申請了治療缺血性中風的配方、劑量和使用方法的權利要求,以及DMT和中風康復的組合療法,包括強制性誘導運動療法。
該公司正在為耶魯大學提供迷幻化合物,用於一項由研究人員發起的臨床試驗,評估多次靜脈劑量的DMT治療抑鬱症。
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