First doses of MB22001 administered in Phase 2B take-home trial in patients with Major Depressive Disorder.
Follows successful Phase 2A trial where 53% of depressed patients were in complete remission from their depression at week 8 marked by a mean 14.1 point drop in MADRS score (Montgomery-Asberg Depression Rating Scale), a 60% mean drop in depressive symptoms.
VANCOUVER, BC / ACCESSWIRE / March 20, 2024 / MindBio Therapeutics Corp. (CSE:MBIO)(Frankfurt:WF6), (the "Company" or "MindBio") is pleased to announce first dosing has begun in a Phase 2B randomised controlled clinical trial microdosing MB22001 in patients with Major Depressive Disorder.
In a world first series of clinical trials, MindBio has secured regulatory and ministerial approvals for MB22001 to be self-administered by participants out in the community and at home. In this Phase 2B randomised, triple blind and active placebo-controlled trial, patients with major depressive disorder (MDD) will undertake an 8 week regimen of MindBio's lead candidate drug, MB22001, a proprietary titratable and self-administered form of Lysergic Acid Diethylamide (LSD) designed for take-home use. In this trial (n=90) half the participants will take an active placebo and the other half will take MB22001. After the 8 week trial, both placebo and drug group participants will be invited to participate in an 8 week open-label extension to ensure the placebo group has the opportunity to experience treatment with MB22001 resulting in potentially 16 weeks of data being collected from every patient.
MindBio's unique investment thesis in the sector, is that small, sub-hallucinogenic doses of a psychedelic drug, MB22001 is the most scalable way to use a psychedelic medicine to treat depressive disorders globally. The Company's goal is to commercialize MB22001 as an affordable, accessible replacement to first line medications such as anti-depressants with low side effects (particularly no sexual side effects, emotional numbness, or weight gain) resulting in greater adherence to the treatment.
Chief Executive Officer of MindBio, Justin Hanka said "Microdosing MB22001 is a disruptive treatment methodology using psychedelic medicines and our ambition is to develop this treatment globally at scale for affordable access to patients without the limitations and side-effects of common anti-depressants".
In February 2024, MindBio completed its Phase 2a trial in patients with Major Depressive Disorder. In this open label trial, patients experienced a 60% drop in depressive symptoms and 53% of patients entering the trial with MDD, at week 8 were in complete remission from their depression marked by an impressive mean 14.1 point drop in MADRS score (Montgomery-Asberg Depression Rating Scale). Prior trial results using MB22001 recorded statistically significant improvements in sleep quality and increases in subjective feelings of "Happiness", "Social Connectivity", "Energy", "Creativity" and "Wellness" with reduced "Anger" and "Irritability". MB22001 is a promising and potential market disruptive medicine for treating depressive illness.
About MindBio Therapeutics
MindBio is a leading biotech/biopharma company focused on creating novel and emerging treatments for mental health conditions and is conducting world first take-home Microdosing (MB22001) human clinical trials. MB22001 is MindBio's lead candidate drug, a proprietary titratable form of Lysergic Acid Diethylamide (LSD) designed for take-home microdosing. MindBio is a leader in microdosing of psychedelic medicines and is advancing its drug and technology protocols through clinical trials. MindBio has developed a multi-disciplinary platform for developing treatments and is involved in psychedelic medicine development and digital therapeutics, has completed Phase 1 clinical trials in 80 healthy partipicipants, has a Phase 2a clinical trial just completed microdosing in patients with Major Depressive Disorder and a Phase 2B clinical trial currently underway microdosing in late stage cancer patients experiencing existential distress. MindBio invests in research that forms the basis for developing novel and clinically proven treatments including digital technologies and interventions to treat debilitating health conditions such as depression, anxiety and other related mental health conditions.
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SOURCE: MindBio Therapeutics
不列顛哥倫比亞省溫哥華/ACCESSWIRE/2024年3月20日/ MindBio Therapeutics Corp.(CSE: MBIO)(法蘭克福:WF6)(“公司” 或 “MindBio”)欣然宣佈,一項針對重度抑鬱症患者的微劑量 MB22001 的2B期隨機對照臨床試驗已開始首次給藥。
在世界上第一個系列臨床試驗中,MindBio 已獲得監管部門和部委的批准,允許社區和家中的參與者自行管理 MB22001。在這項2B期隨機、三盲和活性安慰劑對照試驗中,重度抑鬱症(MDD)患者將接受爲期8周的MindBio主要候選藥物 MB22001 的療程,這是一種專有的可滴定和自行給藥的麥角酸二乙酰胺(LSD),專爲帶回家使用而設計。在這項試驗(n=90)中,一半的參與者將服用活性安慰劑,另一半將服用 MB22001。在爲期 8 周的試驗結束後,安慰劑組和藥物組參與者都將被邀請參加爲期 8 周的開放標籤延期,以確保安慰劑組有機會體驗 MB22001 治療,從而可能從每位患者那裏收集 16 周的數據。
MindBio在該領域的獨特投資論點是,小劑量的亞致幻藥物,MB22001 是全球使用迷幻藥物治療抑鬱症的最具可擴展性的方式。該公司的目標是將 MB22001 商業化,將其作爲抗抑鬱藥等一線藥物的一線藥物的替代品,這種藥物具有低副作用(特別是沒有性副作用、情緒麻木或體重增加),從而提高對治療的依從性。
MindBio 首席執行官賈斯汀·漢卡表示:“微劑量 MB22001 是一種使用迷幻藥物的顛覆性治療方法,我們的目標是在全球範圍內大規模開發這種療法,讓患者能夠負擔得起地獲得常見抗抑鬱藥的限制和副作用”。
2024年2月,MindBio完成了針對重度抑鬱症患者的2a期試驗。在這項開放標籤試驗中,患者的抑鬱症狀下降了60%,進入MDD試驗的患者中有53%在第8周完全緩解了抑鬱症,其標誌是MADRS評分(蒙哥馬利-阿斯伯格抑鬱評級量表)平均下降了14.1個百分點,令人印象深刻。先前使用 MB22001 的試驗結果顯示,睡眠質量有了統計學上的顯著改善,“幸福感”、“社交聯繫”、“精力”、“創造力” 和 “健康” 的主觀感覺有所增加,“憤怒” 和 “煩躁” 減少了。MB22001 是一種治療抑鬱症的前景和潛在的市場顛覆性藥物。
關於 MindBio Therape
MindBio是一家領先的生物技術/生物製藥公司,專注於爲心理健康問題創造新的和新興的治療方法,並且正在進行世界上第一個帶回家的微劑量(MB22001)人體臨床試驗。MB22001 是 MindBio 的主要候選藥物,一種專有的可滴定形式的麥角酸二乙酰胺 (LSD),專爲帶回家的微劑量而設計。MindBio是迷幻藥物微劑量的領導者,正在通過臨床試驗推進其藥物和技術方案。MindBio已經開發了一個用於開發治療的多學科平台,並參與迷幻藥物開發和數字療法,已經完成了對80名健康參與者的1期臨床試驗,一項2a期臨床試驗剛剛完成了對重度抑鬱症患者的微劑量,目前正在進行一項2B期臨床試驗,對面臨生存困擾的晚期癌症患者進行微劑量。MindBio投資的研究爲開發經臨床驗證的新療法奠定了基礎,包括數字技術和干預措施,以治療抑鬱、焦慮和其他相關心理健康狀況等使人衰弱的健康狀況。
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來源:MindBio Therapeutic