{"id":50857,"date":"2022-11-15T08:02:41","date_gmt":"2022-11-15T07:02:41","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/beckley-psytech-successfully-completes-phase-i-clinical-study-of-lead-candidate-bpl-003-a-novel-benzoate-formulation-of-5-meo-dmt\/"},"modified":"2022-11-15T08:02:41","modified_gmt":"2022-11-15T07:02:41","slug":"beckley-psytech-successfully-completes-phase-i-clinical-study-of-lead-candidate-bpl-003-a-novel-benzoate-formulation-of-5-meo-dmt","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/beckley-psytech-successfully-completes-phase-i-clinical-study-of-lead-candidate-bpl-003-a-novel-benzoate-formulation-of-5-meo-dmt\/","title":{"rendered":"Beckley Psytech Successfully Completes Phase I Clinical Study of Lead Candidate BPL-003, a Novel Benzoate Formulation Of 5-MeO-DMT"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nBPL-003 shown to be well-tolerated, with consistent dose delivery, highly reproducible pharmacokinetic profile and reliable induction of profound psychedelic experiences when dosed up to 12 mg in healthy participants\n<\/li>\n<li>\nBPL-003 is Beckley Psytech\u2019s patent-protected benzoate formulation of 5-MeO-DMT and is administered intranasally via an FDA-approved delivery device\n<\/li>\n<li>\nMHRA-approved Phase IIa studies of BPL-003 in Treatment Resistant Depression and Alcohol Use Disorder are expected to initiate in Q4 2022\n<\/li>\n<\/ul>\n<p>OXFORD, England&#8211;(BUSINESS WIRE)&#8211;Beckley Psytech, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric conditions through the novel application of psychedelic medicines, today announced the successful completion of its Phase I clinical study of BPL-003, a synthetic intranasal formulation of 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT), which is under development for Treatment Resistant Depression and Alcohol Use Disorder.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20221114005907\/en\/1636435\/4\/Beckley_Psytech_Logo_high_res.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221114005907\/en\/1636435\/21\/Beckley_Psytech_Logo_high_res.jpg\"><\/a><\/p>\n<p>\nThe double-blind, randomised, single ascending dose study (<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT05347849&amp;esheet=52968895&amp;newsitemid=20221114005907&amp;lan=en-US&amp;anchor=NCT05347849&amp;index=1&amp;md5=511a8e0d12d888a1e1eba54e3981c0a5\" rel=\"nofollow noopener\" shape=\"rect\">NCT05347849<\/a>) explored the safety, tolerability and pharmacokinetics of BPL-003 in combination with psychological support in 44 psychedelic-na\u00efve participants. The participants were split into 6 cohorts and were given either a single dose of BPL-003 between 1 mg to 12 mg or a placebo.\n<\/p>\n<p>\nInitial results show a dose-proportional pharmacokinetic (PK) profile and good tolerability with no serious adverse events reported. BPL-003 demonstrated rapid onset of effect within minutes and a short duration of experience, with all consciousness-altering effects resolving within 90 minutes. With the robust data generated thus far from this Phase I study, Beckley Psytech is now preparing to initiate its MHRA-approved Phase IIa studies evaluating BPL-003 in Treatment Resistant Depression and Alcohol Use Disorder in Q4 2022.\n<\/p>\n<p>\nDr Steve Wooding, CSO of Beckley Psytech, said: \u201c<i>We are pleased to report such positive initial findings from this Phase 1 study of BPL-003 and look forward to sharing a more detailed analysis soon. The safety and tolerability profile, as well as the reliable induction of psychedelic experiences thus far, lay strong clinical foundations for BPL-003\u2019s next stage of development and we are excited to move forward with our Phase II studies in the coming weeks.\u201d<\/i>\n<\/p>\n<p>\nCosmo Feilding Mellen, CEO of Beckley Psytech, added: <i>\u201cBeckley Psytech is making great progress in bringing this innovative formulation of 5-MeO-DMT to patients living with underserved conditions like Treatment Resistant Depression. We are particularly impressed with the fast onset and highly controllable delivery action of BPL-003, which we hope will improve accessibility for both physicians and patients. We look forward to delivering further updates on the progression of BPL-003\u2019s clinical development soon.\u201d<\/i>\n<\/p>\n<p class=\"bwalignc\">\n<b>-Ends-<\/b>\n<\/p>\n<p>\n<b>Beckley Psytech &#8211; <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.beckleypsytech.com&amp;esheet=52968895&amp;newsitemid=20221114005907&amp;lan=en-US&amp;anchor=www.beckleypsytech.com&amp;index=2&amp;md5=649f8927a4e5a3ca6caae3b34219f940\" rel=\"nofollow noopener\" shape=\"rect\">www.beckleypsytech.com<\/a><br \/><\/b>Beckley Psytech is a private, clinical-stage biotechnology company dedicated to improving the lives of people suffering from neuropsychiatric disorders by developing a pipeline of psychedelic compounds into licensed pharmaceutical medicines. The Company\u2019s most advanced programmes are focused on the development of BPL-003, an intranasal synthetic formulation of 5-MeO-DMT, for treatment resistant depression (TRD) and ELE-101, an intravenous synthetic formulation of psilocin, the active metabolite of psilocybin, for major depressive disorder (MDD). Founded in 2019, and underpinned by more than two decades of pioneering scientific research from the Beckley Foundation, we combine world-leading psychedelic science with deep drug development expertise in order to optimise patient outcomes, improve treatment opportunities and ease the burden these conditions have on individuals and society.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nFor more information please contact:\n<\/p>\n<p>\nBeckley Psytech<br \/>\n<br \/>Cosmo Feilding Mellen<br \/>\n<br \/>Chief Executive Officer<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#x74;&#x6f;&#x3a;&#x69;&#x6e;&#x66;&#x6f;&#64;&#98;&#101;&#99;&#107;&#108;&#101;ypsyte&#x63;&#x68;&#x2e;&#x63;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#105;&#x6e;&#102;&#x6f;&#64;&#x62;e&#99;&#x6b;&#108;&#x65;&#121;&#x70;s&#x79;t&#101;&#x63;&#104;&#x2e;c&#x6f;m<\/a>\n<\/p>\n<p>\nCommunications<br \/>\n<br \/>FTI Consulting<br \/>\n<br \/>Ben Atwell \/ Mike Trace\n<\/p>\n<p>\n+44 (0)20 3727 1000<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#x74;&#x6f;&#x3a;&#x62;&#101;&#99;&#107;&#108;&#101;&#121;&#112;syte&#x63;&#x68;&#x40;&#x66;&#x74;&#x69;&#x63;&#x6f;&#x6e;&#115;&#117;&#108;&#116;&#105;&#110;&#103;&#46;com\" rel=\"nofollow noopener\" shape=\"rect\">&#x62;&#x65;&#x63;&#x6b;&#x6c;&#x65;&#x79;&#x70;&#x73;&#x79;&#x74;&#x65;&#x63;&#x68;&#x40;&#x66;&#x74;&#x69;&#x63;&#x6f;&#x6e;&#x73;&#x75;&#x6c;&#x74;&#x69;&#x6e;&#x67;&#x2e;&#x63;&#x6f;&#x6d;<\/a>\n<\/p>\n<p>\nInvestor Relations<br \/>\n<br \/>LifeSci Advisors<br \/>\n<br \/>Guillaume van Renterghem\n<\/p>\n<p>\n+41 76 735 01 31<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;a&#x69;&#108;t&#x6f;&#58;&#x67;&#x76;a&#x6e;&#114;e&#x6e;&#116;&#x65;&#114;g&#x68;&#101;m&#x40;&#108;&#x69;&#102;e&#x73;&#99;&#x69;&#x61;d&#x76;&#105;s&#x6f;&#114;&#x73;&#x2e;c&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#103;&#x76;&#97;&#x6e;&#114;&#x65;&#110;&#x74;&#101;&#x72;&#103;&#x68;&#101;&#x6d;&#64;&#x6c;&#105;&#x66;&#101;&#x73;&#99;&#x69;&#97;&#x64;&#118;&#x69;&#115;&#x6f;&#114;&#x73;&#46;&#x63;&#111;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>BPL-003 shown to be well-tolerated, with consistent dose delivery, highly reproducible pharmacokinetic profile and reliable induction of profound psychedelic experiences when dosed up to 12 mg in healthy participants BPL-003 is Beckley Psytech\u2019s patent-protected benzoate formulation of 5-MeO-DMT and is administered intranasally via an FDA-approved delivery device MHRA-approved Phase IIa studies of BPL-003 in Treatment &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/beckley-psytech-successfully-completes-phase-i-clinical-study-of-lead-candidate-bpl-003-a-novel-benzoate-formulation-of-5-meo-dmt\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-50857","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Beckley Psytech Successfully Completes Phase I Clinical Study of Lead Candidate BPL-003, a Novel Benzoate Formulation Of 5-MeO-DMT - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/beckley-psytech-successfully-completes-phase-i-clinical-study-of-lead-candidate-bpl-003-a-novel-benzoate-formulation-of-5-meo-dmt\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Beckley Psytech Successfully Completes Phase I Clinical Study of Lead Candidate BPL-003, a Novel Benzoate Formulation Of 5-MeO-DMT - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"BPL-003 shown to be well-tolerated, with consistent dose delivery, highly reproducible pharmacokinetic profile and reliable induction of profound psychedelic experiences when dosed up to 12 mg in healthy participants BPL-003 is Beckley Psytech\u2019s patent-protected benzoate formulation of 5-MeO-DMT and is administered intranasally via an FDA-approved delivery device MHRA-approved Phase IIa studies of BPL-003 in Treatment ... 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