VANCOUVER, British Columbia, April 04, 2023 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the "Company" or "AGN Pharma") (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian clinical stage pharmaceutical development company, is pleased to advise that its subsidiary Algernon NeuroScience (AGN Neuro), has completed dosing of the second cohort in its escalating dose Phase 1 clinical study of an intravenous formulation of AP-188 ("N,N-Dimethyltryptamine" or "DMT"). AGN Neuro also reports that the safety review committee has approved moving the study forward with the final cohort at an escalated dose after observing no safety or tolerability issues.
The trial is being conducted at the Centre for Human Drug Research ("CHDR") in Leiden, Netherlands. The purpose of the study is to identify the safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by a prolonged infusion of 6 hours, a period which has never been studied clinically. In addition, several pharmacodynamic measures believed to be associated with neuroplasticity, including both measurements of biochemical markers and electroencephalographic readings, will be recorded.
Once the correct dose has been established in the first part of the study, the second part of the study will include dosing subjects for 6 hours with repeated dosing over a two-week period. There will be up to 60 healthy volunteers enrolled in total, which will include both psychedelic experienced and psychedelic naïve subjects.
The Company is working with its top stroke and traumatic brain injury (TBI) experts to design Phase 2 studies for the continued investigation of DMT.
"This is another important step in our DMT clinical research program," said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. "The sooner we can finalize the correct dose and the optimum exposure period, the faster we can move into Phase 2 studies where we can test DMT on patients that have suffered a serious brain injury."
About DMT
N,N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD, ketamine, psilocybin and psilocin. DMT occurs naturally in many plant species and animals including humans and has been used in religious ceremonies as a traditional spiritual medicine by indigenous people in the Amazon basin. DMT can also be synthesised in a laboratory.
Algernon has filed patents for DMT pamoate and nicotinate (novel salt forms of DMT), in addition to formulation, dosage and method of use claims for ischemic stroke. The Company has also filed claims for combination therapy of DMT and stroke rehabilitation including Constraint Induced Movement Therapy.
About Algernon NeuroScience
Algernon NeuroScience is a private equity subsidiary of Algernon Pharmaceuticals and has been created to advance the Company's DMT stroke and traumatic brain injury (TBI) research program. AGN Neuro has filed a Form 1-A offering statement with the U.S. Securities and Exchange Commission, which was qualified on March 8, 2023 to raise up to USD $10M for AGN Neuro by offering up to 37.5% of its common shares, (including the maximum amount of bonus shares) with majority ownership residing with AGN Pharma, under a Tier II Regulation A+ offering. For more information visit .
About Algernon Pharmaceuticals Inc.
Algernon Pharmaceuticals is a Canadian clinical stage drug development and repurposing company investigating multiple drugs for unmet global medical needs. Algernon Pharmaceuticals has active research programs for IPF with chronic cough, and chronic kidney disease, and is the parent company of a newly created private subsidiary called Algernon NeuroScience, that is advancing a psychedelic program investigating a proprietary form of psychedelic DMT for stroke and TBI. For more information visit .
CONTACT INFORMATION
Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
.
Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company's expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.
温哥华,不列颠哥伦比亚省,2023年4月4日(环球网)--加拿大临床阶段药物开发公司Algernon PharmPharmticals Inc.(以下简称“公司”或“AGN Pharma”)(CSE:AGN)(法兰克福股票代码:AGW0)(场外交易代码:AGNPF)欣然通知,其子公司Algernon Neuro(AGN Neuro)已完成AP-188静脉注射制剂(“N,N-二甲基色胺”或“DMT”)剂量递增第一阶段临床研究的第二组给药。AGN Neuro还报告说,在没有观察到安全性或耐受性问题后,安全审查委员会已经批准将研究向前推进,并以更高的剂量进行最终队列研究。
该试验在荷兰莱顿的人类药物研究中心(CHDR)进行。这项研究的目的是确定DMT的安全性、耐受性和药代动力学,当DMT作为静脉推注给药后再长时间输注6小时,这段时间从未在临床上进行过研究。此外,一些被认为与神经可塑性有关的药效学测量,包括生化标记物和脑电读数的测量,将被记录下来。
一旦在研究的第一部分确定了正确的剂量,研究的第二部分将包括给受试者6小时的剂量,在两周内重复给药。总共将有多达60名健康志愿者参加,其中包括有迷幻经验的和迷幻NAÏVE的受试者。
该公司正在与其顶尖的中风和创伤性脑损伤(TBI)专家合作,为DMT的持续研究设计第二阶段研究。
Algernon制药公司首席执行官克里斯托弗·J·莫罗说:“这是我们DMT临床研究计划的又一个重要步骤。我们越早敲定正确的剂量和最佳暴露时间,我们就越快进入第二阶段研究,在那里我们可以在遭受严重脑损伤的患者身上测试DMT。“
关于DMT
N,N-二甲基色胺,或称DMT,是一种致幻色胺药物,产生的效果类似于其他迷幻剂,如LSD、氯胺酮、裸盖菇素和裸盖菇素。DMT自然存在于包括人类在内的许多植物和动物中,并被亚马逊盆地的土著人民用作宗教仪式中的一种传统精神药物。DMT也可以在实验室中合成。
除了治疗缺血性中风的配方、剂量和使用方法外,Algernon还申请了DMT帕莫酸盐和尼古丁(DMT的新型盐形式)的专利。该公司还提出了对DMT和中风康复的联合治疗的索赔,包括强制性诱导运动疗法。
关于阿尔杰农神经科学
Algernon神经科学公司是Algernon制药公司的一家私人股本子公司,成立该公司是为了推进该公司的DMT中风和创伤性脑损伤(TBI)研究计划。AGN Neuro已向美国证券交易委员会提交了Form 1-A发售声明,该委员会于2023年3月8日获得资格,根据第二级法规A+发售,通过发行其最多37.5%的普通股(包括最高额度的红股),为AGN Neuro筹集至多1000万美元的普通股,其中多数股权由AGN Pharma持有。有关更多信息,请访问。
关于Algernon制药公司
Algernon制药公司是一家加拿大临床阶段药物开发和再利用公司,为未得到满足的全球医疗需求调查多种药物。Algernon制药公司对患有慢性咳嗽和慢性肾脏疾病的IPF有积极的研究计划,是新成立的一家名为Algernon NeuroScience的私人子公司的母公司,该子公司正在推进一项迷幻计划,研究一种治疗中风和脑损伤的专有形式的迷幻DMT。有关更多信息,请访问。
联系信息
克里斯托弗·J·莫罗
首席执行官
阿尔杰农制药公司。
604.398.4175转701
邮箱:info@algernon PharmPharmticals.com
邮箱:Investors@algernon PharmPharmticals.com
。
加拿大证券交易所及其市场监管机构(该术语在加拿大证券交易所的政策中定义)均不对本新闻稿的充分性或准确性承担责任。
告诫免责声明:没有任何证券交易所对本新闻稿内容的充分性或准确性进行审查或承担责任。本新闻稿包含与产品开发、许可、商业化和监管合规问题有关的前瞻性陈述,以及其他非历史事实的陈述。前瞻性陈述通常用“将”、“可能”、“应该”、“预期”、“预期”和类似的表达方式来识别。除历史事实陈述外,本新闻稿中包含的所有陈述均为前瞻性陈述,涉及风险和不确定性。不能保证这些陈述将被证明是准确的,实际结果和未来事件可能与这些陈述中预期的大不相同。可能导致实际结果与公司预期大相径庭的重要因素包括未能满足相关证券交易所的条件以及公司不时提交给证券监管机构的文件中详述的其他风险。提醒读者,在准备任何前瞻性信息时使用的假设可能被证明是不正确的。由于许多已知和未知的风险、不确定性和其他因素,其中许多是公司无法控制的,事件或情况可能会导致实际结果与预测的结果大不相同。提醒读者不要过度依赖任何前瞻性信息。这些信息虽然在准备时被管理层认为是合理的,但可能被证明是不正确的,实际结果可能与预期的大不相同。本新闻稿中包含的前瞻性陈述明确地受到本警示性声明的限制。本新闻稿中包含的前瞻性陈述是截至本新闻稿发布之日作出的,公司将根据适用法律的明确要求,公开更新或修改任何包含的前瞻性陈述。