Safety, tolerability, pharmacokinetics, and subjective effects of 50, 75, and 100 µg LSD in healthy participants within a novel intervention paradigm: A proof-of-concept study

3区 · 医学

Article

作者: Family, Neiloufar ; Krediet, Erwin ; Luke, David ; Hendricks, Peter S ; Maillet, Emeline L ; Williams, Luke TJ ; Raz, Shlomi

Background: Classic psychedelics hold promise as therapeutics for psychiatric disorders, but require scalable intervention protocols. This proof-of-concept study evaluated the safety, tolerability, pharmacokinetics, and subjective effects of 50, 75, and 100 µg lysergic acid diethylamide (LSD) in healthy adults within a novel intervention paradigm. Methods: Up to three participants were administered LSD on the same day in separate rooms, each with a single attendant, after 1 day of preparation. An open-label design and a double-blind placebo-controlled design were used. Results: Ninety-one percent of participants completed the study. Thirty-two adults (mean age = 28.8 years) received 50 (n = 3), 75 (n = 7), 100 (n = 3) LSD, 50 µg followed by 75 µg LSD (n = 9) 1 week apart, or placebo followed by a 75 µg LSD (n = 10) 1 week apart. There were no serious adverse events. Twenty-eight percent of participants experienced at least one expected mild adverse event, with one expected moderate adverse event. The maximum blood plasma levels occurred between 1.2 and 2 h post-administration, with an apparent half-life between 2.8 and 4.3 h. LSD largely induced greater subjective effects versus placebo. Conclusion: In the current novel intervention paradigm, 50, 75, and 100 µg LSD are tolerable with favourable safety profiles in healthy adults, only mild adverse events during the day of drug administration, and mystical-type subjective experiences. Future studies are needed to evaluate safety, tolerability, subjective effects, and cost-effectiveness in clinical populations.

2022-03-01·Journal of Psychopharmacology3区 · 医学

Perceptions of safety, subjective effects, and beliefs about the clinical utility of lysergic acid diethylamide in healthy participants within a novel intervention paradigm: Qualitative results from a proof-of-concept study

3区 · 医学

Article

作者: Raz, Shlomi ; Hendricks, Peter S ; Family, Neiloufar ; Luke, David ; Copes, Heith ; Williams, Luke TJ

Background: Classic psychedelics show promise in the treatment of mental health conditions; however, more scalable intervention protocols are needed to maximize access to these novel therapeutics. In this proof-of-concept study, perceptions of safety, subjective effects, and beliefs about the clinical utility of lysergic acid diethylamide (LSD) were evaluated among healthy participants ( N = 31) administered 50 to 100 µg LSD in a treatment paradigm conceptualized as more scalable than traditional approaches to administering classic psychedelics. Methods: Semi-structured interviews assessed participants’ expectations, experience, and thoughts on the safety and efficacy of the study design. These interviews were transcribed for thematic analysis relating to perceptions of safety, subjective effects, and beliefs about the clinical utility of LSD. Results: Most participants felt safe throughout the study, with a minority reporting concerns related to having a challenging experience that diminished over time. Participants attributed their feelings of safety to the study structure and support of their attendants, which allowed them to “let go” and immerse themselves in the experience without pre-occupation. Furthermore, participants reported transcendent, mystical-type experiences characteristic of classic psychedelics, with almost half highlighting the prominent role played by music during the acute period of drug action. Finally, participants endorsed support for the clinical utility of LSD in controlled environments, expressing the belief that LSD is safe and has the potential to help others. Conclusion: Findings provide preliminary support for the feasibility of this scalable interventional paradigm and set the stage for future critical research with clinical populations.

2020-03-01·Psychopharmacology3区 · 医学

Safety, tolerability, pharmacokinetics, and pharmacodynamics of low dose lysergic acid diethylamide (LSD) in healthy older volunteers

3区 · 医学

Article

作者: Family, Neiloufar ; Nichols, Charles D ; Goble, Daniel J ; Maillet, Emeline L ; Krediet, Erwin ; Williams, Tim M ; Carhart-Harris, Robin L ; Raz, Shlomi ; Williams, Luke T J

AbstractAbstractResearch has shown that psychedelics, such as lysergic acid diethylamide (LSD), have profound anti-inflammatory properties mediated by 5-HT2A receptor signaling, supporting their evaluation as a therapeutic for neuroinflammation associated with neurodegenerative disease.ObjectiveThis study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally repeated administration of 5 μg, 10 μg, and 20 μg LSD in older healthy individuals. In the current paper, we present safety, tolerability, pharmacokinetics, and pharmacodynamic measures that relate to safety, tolerability, and dose response.MethodsThis was a phase 1 double-blind, placebo-controlled, randomized study. Volunteers were randomly assigned to 1 of 4 dose groups (5 μg, 10 μg, 20 μg LSD, and placebo), and received their assigned dose on six occasions (i.e., every 4 days).ResultsForty-eight older healthy volunteers (mean age = 62.9 years) received placebo (n = 12), 5 μg (n = 12), 10 μg (n = 12), or 20 μg (n = 12) LSD. LSD plasma levels were undetectable for the 5 μg group and peak blood plasma levels for the 10 μg and 20 μg groups occurred at 30 min. LSD was well tolerated, and the frequency of adverse events was no higher than for placebo. Assessments of cognition, balance, and proprioception revealed no impairment.ConclusionsOur results suggest safety and tolerability of orally administered 5 μg, 10 μg, and 20 μg LSD every fourth day over a 21-day period and support further clinical development of LSD for the treatment and prevention of Alzheimer’s disease (AD).

项与 Eleusis Holdings Ltd. 相关的新闻（医药）

2023-02-17

·GlobeNewswire-Health Care

Bright Minds Biosciences Announces Non-Executive Director Appointment

David Weiner, MD, brings extensive experience in the discovery and clinical development of novel therapeutics for neurological, psychiatric and rare diseasesNOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION, DISTRIBUTION OR DISSEMINATION DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES VANCOUVER, British Columbia, Feb. 17, 2023 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (CSE:DRUG) (NASDAQ:DRUG) (“Bright Minds” or the “Company”), a biotechnology company focused on developing novel drugs for the targeted treatment of neuropsychiatric disorders, epilepsy, and pain, today announced the appointment to its board of directors (the “Board”) of David Weiner, MD, as a non-executive director. The appointment is effective immediately. “I am delighted to welcome David to the Bright Minds Board. He is an accomplished neuroscientist and biotech entrepreneur who brings extensive experience in the psychedelics space. The breadth of his work with 5-HT2A compounds is ideally suited to supporting the advancement of our next-generation programs. David holds several patents in the area of selective serotonin modulators, and we look forward to his contributions to the Company,” said Ian McDonald, CEO and Co-founder of Bright Minds Biosciences. “It is an honor to join the Bright Minds Board as the Company transitions from a discovery to a development organization. I am eager to share my perspectives and experience to help Bright Minds progress its innovative clinical and preclinical drug discovery programs,” stated David Weiner, MD. Dr. Weiner has over 25 years of experience in the discovery and clinical development of novel therapeutics for neurological, psychiatric and rare diseases. He began his career at ACADIA Pharmaceuticals, where he held a series of discovery research and clinical development roles working on multiple central nervous system (CNS) therapeutics, most notably pimavanserin, a 5-HT2A receptor inverse agonist, which is approved for the treatment of Parkinson’s disease psychosis. Dr. Weiner also served as the Chief Medical Officer (CMO) and Interim Chief Executive Officer (CEO) for Proteostasis Therapeutics, CMO at aTyr Pharma and Lumos Pharma, CEO at Amathus Therapeutics, and as an independent board member and senior executive at Eleusis, a company focused on therapeutic development of psychedelics and novel 5-HT2A receptor agonists. He has authored more than 30 scientific publications and patents and serves on multiple clinical and scientific advisory boards, including the Michael J. Fox Foundation for Parkinsons Research. He received his M.D. from the School of Medicine and Biomedical Sciences, SUNY at Buffalo, was a Howard Hughes Medical Institute Research Scholar at the NIH, trained in neurology at New York Hospital, Memorial Sloan Kettering, Cornell Medical Center, and did a post-doctoral fellowship in neuropharmacology at the University of Vermont. Dr. Weiner has also been appointed to the Company’s Audit Committee, Compensation Committee, and Corporate Governance Committee. Following Dr. Weiner’s appointment to the Board and the Audit Committee, the Company has regained compliance with the independent director and audit committee requirements as set forth in Nasdaq Listing Rule 5605. Option Grants The Company is also pleased to announce that it has granted an aggregate of 235,000 stock options (the “Options”) to consultants and a director of the Company to purchase 235,000 common shares (the “Shares”) in the capital of the Company pursuant to the Company’s share option plan. The Options are exercisable at an exercise price of $1.05 per Share for a period of five (5) years from the date of grant. The Options are subject to vesting periods over the course of the term of the Options About Bright Minds Bright Minds is focused on developing novel transformative treatments for neuropsychiatric disorders, epilepsy, and pain. Bright Minds has a portfolio of next-generation serotonin agonists designed to target neurocircuit abnormalities that are responsible for difficult to treat disorders such as resistant epilepsy, treatment resistant depression, PTSD, and pain. The Company leverages its world-class scientific and drug development expertise to bring forward the next generation of safe and efficacious drugs. Bright Minds’ drugs have been designed to potentially retain the powerful therapeutic aspects of psychedelic and other serotonergic compounds, while minimizing the side effects, thereby creating superior drugs to first-generation compounds, such as psilocybin. Investor Contacts:Lisa WilsonE: lwilson@insitecony.comT: 917-543-9932 Ian McDonaldCEO and DirectorE: ian@brightmindsbio.comT: 917-543-9932 This news release includes certain statements that may be deemed “forward-looking statements”. All statements in this new release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include market prices, continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company’s management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change. Neither the Canadian Securities Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

高管变更

2022-07-11

·药时代

2022年6月生物医药企业上市情况

2022年6月，在生物医药领域，仅有1家公司通过IPO上市，4家公司宣布或完成与SPAC合并上市，1家公司进行反向并购上市，2家公司提交了转板上市申请。一、IPO上市6月，仅有1家医药公司采用IPO形式上市，比5月减少了2家，IPO市场陷入谷底。作为6月唯一一家IPO上市的生物医药企业，Heart Test(NASDAQ:HSCS)的IPO价格为4.25美元，发行1500万股，募集金额为6375万美元。HSCS是一家基于人工智能的心电图公司，用于筛查、护理心脏病患者，公司产品MyoVistawavECG已经获得FDA批准，是一款静息12导联心电图。HSCS的年营收规模仅为几万美元，无论是财务数据上，还是发行体量上，公司均属于质地较差的公司，股价更容易被资金左右：IPO当天，公司股价暴跌54.67%，第二天又上涨42.35%。二、SPAC上市6月，有2家SPAC公司宣布与生物医药企业合并，2家药企完成与与SPAC公司合并上市，另有2家此前计划与SPAC合并上市的医药公司，宣布终止合并。1、Alvotech(NASDAQ:ALVO)6月7日，SPAC公司Oaktree II(NYSE:OACB)完成与Alvotech合并，合并后的公司上市代码为“ALVO”。Alvotech是一家来自冰岛的生物类似药公司，主打产品是艾伯维阿达木单抗的生物类似药，Alvotech开发了一种高浓度的阿达木单抗，可以提高患者的依从性，并可能使其比其他一些已经批准的阿达木单抗生物仿制药更具竞争力，并且在美国它可能比大多数阿达木单抗生物仿制药更早上市，此前已经获得了欧盟委员会批准（2021年11月）在欧盟国家进行商业化。艾伯维的阿达木单抗专利将于2023年到期，安进、勃林格殷格翰、辉瑞等药企均准备推出生物类似药。除了阿达木单抗类似药之外，Alvotech还在就强生的Stelara和Simponi、再生元的Eylea和安进的Prolia/Xgeva开发生物类似药。Alvotech和亚洲投资人颇具渊源，公司先后接纳了日本富士、韩国新韩、新加坡淡马锡等股东，并与2018年和长春高新联合成立了长春安沃高新生物制药公司，旨在中国境内开发生物类似药。2、Senti Biosciences(NASDAQ:SNTI)6月8日，SPAC 公司Dynamics (NASDAQ:DYNS)宣布完成与Senti Biosciences合并上市，合并后公司的上市代码为“SNTI”。Senti Bio 是一家利用基因工程电路技术设计基因和细胞疗法的初创公司，由合成生物学奠基人James J. Collins及其学生卢冠达等联合创办。公司利用其专有的基因电路技术平台能够感知并治疗相关疾病，即通过合成生物学方式创建多种基因电路并编码为专有的DNA序列组合。这种基因电路能够使细胞感应到信号，并利用生物逻辑计算对疾病做出判断。Senti Bio已经开发出了三条在研管线，分别针对急性髓性白血病（AML）、肝癌和结直肠癌，均处于临床前阶段，预计到明年递交针对AML和肝癌的IND。公司独特的技术吸引了大药企的合作：公司与罗氏子公司Spark Therapeutics 合作开发针对中枢神经系统、眼部和肝脏部位的“下一代”基因疗法，还与拜耳的子公司BlueRock Therapeutics达成开发“下一代”细胞疗法合作。公司创始人卢冠达是MIT生物工程与电机工程系副教授，也是知名的连续创业者。目前，他已联合创办了8家生物技术公司，此前他联合创办的Synlogic（SYBX）、BiomX（PHGE）、Tango（TNGX）均已上市。公司在一级市场上获得了安进、拜耳、NEA、经纬中国、英特尔等知名机构的投资。此次完成合并的SPAC公司DYNS，有着资深的行业背景，DYNS的发起人包括 Omid Farokhzad、Mostafa Ronaghi等行业大牛，亦获得了ARK Investment的投资，其中：DYNS的执行主席Omid Farokhzad是蛋白质组学上市公司Seer的联合创始人兼CEO；DYNS的CEO兼董事Mostafa Ronaghi曾在Illumina担任13年CTO，也是癌症检测领域超级独角兽GRAIL的联合创始人。3、Freedom Acquisition(NASDAQ:FACT)6月21日，SPAC公司FACT宣布与Human Longevity达成合并上市的协议，合并后的公司估值约为10亿美元，预计交易在明年一季度完成。Human Longevity由基因组学领域先驱J. Craig Venter于2013年创立，通过利用基因组测序、人类微生物组、蛋白质组学和细胞疗法等技术领域的成果，计划建设最全面的人类基因型和表现型数据库。公司具体业务领域包括：基因组测序分析，先进的临床成像及机器学习、定制化的个人健康信息等。公司为用户提供名为“Health Nucleus”的健康服务，其中包括百余项健康评估的医学测试，例如全基因组测序、全身定量 MRI 和血液生物标志物检测等，用于测试癌症、阿尔茨海默氏症和心脏病等疾病的早期迹象，从而帮助人们尽早发现并对抗与衰老相关的疾病。公司曾在2016年的B轮融资中，募集了2.2亿美元的资金，成功吸引了Illumina公司，Celgene公司，GE公司等巨头的加入，公司估值也超过12亿美元。2018年，公司起诉了Venter及其同名的研究所存在分享公司机密的行为之后，导致几位管理层的离职，在2018年底，公司估值跌去了80%，导致在2019年的C轮融资中，公司仅筹集到了3000万美元。4、宣布终止合并生物医药企业的SPAC公司6月，共有2家SPAC公司宣布终止正在推进的生物医药企业合并计划：6月9日，Psychedelics药物公司Eleusis宣布终止与与SPAC 公司Spike Acquisition Corp.II（NASDAQ:SPKB）的合并上市计划；6月13日，专注于纤维化疾病的小分子药物公司Blade Therapeutics宣布终止与SPAC公司Biotech(NASDAQ:BIOT)的合并上市计划。三、反向并购上市（Reverse Merger）6月6日，中枢神经系统系统药物公司Yumanity(NASDAQ:YMTX)宣布将其在研药物YTX-7739以2600万美元的价格，出售给强生(NYSE:JNJ)，并将与未上市的生物医药公司Kineta进行换股合并，完成后，原YMTX的股东将持有合并后公司15%的股权。YMTX是本轮生物医药熊市中，研发不利药企的一个缩影，公司把出售资产的资金分配给股东，并与Kineta达成反向并购上市协议。而YMTX自身，则是在2020年8月，与Proteostasis(NASDAQ:PTI)进行反向并购上市，时间不到两年，上市公司的壳再度易手。Kineta的主要资产是KVA12.1，是一款靶向VISTA的免疫疗法，用于解决肿瘤微环境中的免疫抑制问题，拥有治疗多种癌症的潜力。除了肿瘤免疫疗法之外，公司还有与基因泰克合作开发的管线：一款用于神经性疼痛治疗的药物。此外，YMTX与默克公司合作开发治疗肌萎缩侧索硬化症和额颞叶痴呆的在研管线也会划归合并后的上市公司。四、转板上市（Uplisting）6月，共有2家公司宣布从OTC板块，转板到纳斯达克上市，一般而言，转板上市的医药企业质地较差：Clearmind Medicine ( OTC:CMNDF )：一家致力于开发治疗暴饮暴食、酗酒等症状的迷幻药物公司，主打药物MEAI目前正处于I/IIa期临床试验。公司还在近期，与SciSparc(NASDAQ:SPRC)联合申请了治疗暴食行为药物的专利。ImmunoCellular(OTC:IMUC)：公司于今年6月递交了转板纳斯达克上市的申请，有两个进入临床二期实验的在研药物：EOM613 和 EOM147。EOM613三中是艾滋病和类风湿性关节炎，EOM147适应症是年龄相关性黄斑变性、糖尿病性视网膜病变等眼科疾病。在2021年12月，公司与EOM Pharmaceuticals合并，今年6月，提交了在纳斯达克上市的申请，股票代码拟变更为“EOM”。版权声明/免责声明本文为授权转载文章，版权归拥有者。仅供感兴趣的个人谨慎参考，非商用，非医用、非投资用。欢迎朋友们批评指正！衷心感谢！文中图片、视频为授权正版作品，或来自微信公共图片库，或取自公司官网/网络根据CC0协议使用，版权归拥有者。任何问题，请与我们联系（电话：13651980212。微信：27674131。邮箱：contact@drugtimes.cn）。衷心感谢！推荐阅读2022年上半年中国新药出海成绩单！国产PD-1再次奋勇出海，百济神州和君实谁能率先成功上岸？。。。 | 药时代出海系列不出国可以用上哪些全球最新药？| 在“国九条”、“先行先试”等政策加持下，海南博鳌乐城先行区是如何“先行”的？水性凝胶贴片的机理与国外临床试验H空出世大有可为 | CSCO-复宏汉霖肿瘤免疫高峰论坛圆满举行核酸药物“三步走”：如何从研发角度推动药物进程三款上市新药，十余项注册研究，收获期的和黄医药如何打好商业化这张牌？| 药时代专访和黄医药中国首席商务官陈洪先生出于安全考虑，赛诺菲BTK抑制剂tolebrutinib的3期临床研究被FDA部分暂停寻找「制药界董宇辉」！为中国创新代言，为优秀公司带货！——药时代直播招聘啦！“大糖盛世”下我国糖尿病市场的机遇与挑战半年收官！NMPA「官宣」批准上市9款创新药、疫苗点击这里，欢聚药时代！