Psyence Biomed Announces Initiation of First Trial Site in Australia for its Phase IIb Study of Nature Derived Psilocybin as a Potential Treatment for Adjustment Disorder in Palliative Care

GlobeNewswire09-09

Patient screening to be initiated imminently; first subject expected to be randomized into the study in October NEW YORK, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“...

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(Nasdaq: PBM) (“...</p>\n\n<a href=\"https://finance.yahoo.com/news/psyence-biomed-announces-initiation-first-113000475.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://finance.yahoo.com/news/psyence-biomed-announces-initiation-first-113000475.html","article_id":"2466016621","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/NTgIdxqiLMziWZlqTH9KVQ--~B/aD04NTt3PTIwMDthcHBpZD15dGFjaHlvbg--/https://media.zenfs.com/en/globenewswire.com/2b362d1b510647247b266a9002bacf8d"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2466016621","pubTimestamp":1725881400,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Patient screening to be initiated imminently; first subject expected to be randomized into the study in October. NEW YORK, Sept. 09, 2024  -- Psyence Biomedical Ltd.  , a developer of naturally derived psilocybin-based therapeutics, today announced that the first site initiation visit has been successfully completed at the first Australian clinical trial site for the Company’s Phase IIb study of nature derived  psilocybin as a potential treatment for Adjustment Disorder in the Palliative Care context.Psyence Biomedical Ltd.  is the world’s first life science biotechnology company focused on the development of botanical  psilocybin-based psychedelic medicine to be listed on Nasdaq. The name “Psyence” combines the words “psychedelics” and “s","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","PBM":"Psyence Biomedical Ltd","PBMWW":"PSYENCE BIOMEDICAL LTD C/WTS 25/01/2029(TO PUR COM)"},"translate_title":"Psyence Biomed宣布在澳大利亚启动第一个试验点，对天然裸盖菇素作为姑息治疗中适应障碍的潜在治疗方法的IIb期研究","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PBM":0.9,"PBMWW":0.9},"content_text":"Patient screening to be initiated imminently; first subject expected to be randomized into the study in October\nNEW YORK, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”), a developer of naturally derived psilocybin-based therapeutics, today announced that the first site initiation visit has been successfully completed at the first Australian clinical trial site for the Company’s Phase IIb study of nature derived (non-synthetic) psilocybin as a potential treatment for Adjustment Disorder in the Palliative Care context.\nPsyence previously announced that it has entered into partnerships with Fluence, a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to support the study. In July, Psyence announced the successful export of the drug product, PEX010, to Australia, which marked a crucial step in preparation for initiation of the study. The affiliated trial site will soon commence screening patients, and the first subject is expected to be randomized into the study in October.\n“The imminent activation of the first trial site and patient screening for this trial represents a significant milestone for our company, and a positive step forward for the advancement of psychedelic-based therapeutics generally,” said Dr. Clive Ward-Able, Medical Director of Psyence Biomedical. “Together with our partners, iNGENū and Fluence, we will endeavor to quickly enroll this study, and we look forward to topline data in the back half of next year that, if positive, will support the initiation of a pivotal Phase III clinical program as soon as practicable thereafter.”\n“As a leading global contract research organization that has notable experience in the execution of psychedelic clinical trials, we believe psilocybin holds great promise as a treatment for a broad range of mental health conditions with unmet needs,” said iNGENū CRO Senior Clinical Project Manager, Veronika Simic. “We are pleased to partner with Psyence Biomedical as they work to introduce a novel, psilocybin-based treatment to patients suffering from Adjustment Disorder following a life limiting cancer diagnosis in Palliative Care, and we are prepared to advance this rigorously designed study as efficiently as possible.”\nThe randomized, double-blind, placebo-controlled Phase IIb study will evaluate two therapeutic doses of nature-derived psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 87 patients in conjunction with psychotherapy.\nMore information on the study can be found at: 12624000449538p.\nAbout Psyence Biomedical\nPsyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company focused on the development of botanical (nature-derived and non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. The name “Psyence” combines the words “psychedelics” and “science” to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Psyence is initially focused on mental health disorders in the context of Palliative Care.\nLearn more at www.psyencebiomed.com and on LinkedIn.\nContact Information\nEmail: ir@psyencebiomed.comMedia Inquiries: media@psyencebiomed.comGeneral Information: info@psyencebiomed.comPhone: +1 416-477-1708\nInvestor Contact:Jeremy FefferManaging DirectorLifeSci Advisorsjfeffer@lifesciadvisors.com\nForward Looking Statements This communication contains \"forward-looking statements\" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as \"will likely result,\" \"are expected to,\" \"will continue,\" \"is anticipated,\" \"estimated,\" \"believe,\" \"intend,\" \"plan,\" \"projection,\" \"outlook\" or words of similar meaning. \nForward-looking statements in this communication include statements regarding the commencement of the clinical trial referred to in this news release and the safety and effectiveness of psilocybin as a treatment option for adjustment disorder within the context of Palliative Care. These forward-looking statements are based on a number of assumptions, including the assumption that that trial site initiation and patient recruitment will be successful in accordance with the expected timelines, and that trial results will support the initiation of Phase III registrational trials.\nThere are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) the ability of iNGENū to execute its obligations in respect of the clinical trial; (ii) changes in applicable laws which may impact the clinical trial and/or the conducting thereof; (iii) Psyence Australia Pty Ltd’s ability to achieve successful clinical results; (iv) Psyence Biomed’s ability to obtain regulatory approval for its product candidates, and any related restrictions or limitations of any approved products; (v) Psyence Biomed’s ability to obtain licensing of third-party intellectual property rights and supply of raw materials for future discovery and development of its product candidates; (vi) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (vii) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulated industries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business and changes in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the \"Risk Factors\" section of the final prospectus filed by the Company with the SEC on August 30, 2024 and other documents filed by the Company from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such information. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, the Company does not intend to update these forward-looking statements.\nThe Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.26.4","shortVersion":"4.26.4","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2466016621"}