Psilocybin

May 14, 2025 -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB : BETRF / FRA: NPAU), an emerging biotech company focused on the development of BETR-001, a non-hallucinogenic neuroplastogen in the treatment of psychiatric and neurological disorders, recently presented a scientific update at Bloom Burton Conference on May 5, 2025 in Toronto, Canada. BetterLife reported that its proprietary compound, BETR-001, is showing very promising preclinical data of its breakthrough ability to provide therapeutic effect in depression/anxiety animal models. Current methods of treating depression/anxiety primarily focus on increasing the level of one of the three neurotransmitters: serotonin, norepinephrine and/or dopamine in the brain. Each neurotransmitter has different receptor targets, and each receptor performs different functions. Current treatments are usually reuptake inhibitors such as SSRIs (selective serotonin reuptake inhibitors) and by increasing the amount of a neurotransmitter, all its receptors are activated. What is needed are new treatments that activate the neuroreceptors themselves, and more importantly, only selective subsets of these receptors. The therapeutic effects of BETR-001 seen in preclinical models are primarily driven by its activation (agonism) of serotonin’s 5HT2A receptor. Not only does BETR-001 activate the 5HT2A receptor, which plays a key role in depression/anxiety, this activation is via a mechanism that allows for a highly efficacious therapeutic effect without hallucinogenic side effects. This stands in contrast to other potent 5HT2A activators, such as LSD, psilocybin and other psychedelics. BetterLife has reported on the details of BETR-001 activation of the 5HT2A receptor previously (Lewis et al., Cell Reports, 2023). Recently studies have shown that the activation of the 5HT2A receptor above 70% leads to hallucination (Wallach et al., Nature Communications, 2023). Ideally, a therapeutic agent should activate 5HT2A but stay below the 70% threshold. BETR-001 fulfills this parameter perfectly: activating 5HT2A maximally to 60%, unlike LSD, which activates 5HT2A to near 90%. This is shown in our 5HT2A receptor activation data below, where the X-axis is an increasing amount of the drug, and the Y axis is the percentage activation of the 5HT2A receptor. The drugs tested are 5-HT (the parent serotonin), LSD and BETR-001. BetterLife believes that BETR-001’s novel mechanism of action provides a new paradigm for treatment of psychiatric disorders such as depression, anxiety and PTSD. It activates the 5HT2A receptor partially but stays below the hallucination threshold. In addition, unlike LSD, psilocybin, MDMA and other such agents BETR-001 is not an activator of the 5HT2B receptor. Activation of 5HT2B has been linked to cardiac safety. The neuroreceptor selectivity of BETR-001 in this regard is another of its key advantages over other competitor agents. An additional benefit of BETR-001 is that repeated dosing does not induce tolerance, unlike classic agents like LSD. This allows daily administration if needed. Furthermore, the lack of hallucinations with BETR-001 means it is a non-controlled substance and patient self-administration at home is possible. Finally, an overarching property of BETR-001 is that it is a very potent neuroplastogen. BetterLife has been granted a composition of matter patent on BETR-001 by the USPTO (BetterLife press release January 14, 2025). BetterLife has had its BETR-001 pre-IND meeting with the FDA and has completed most of the required IND-enabling studies. The BETR-001 IND filing and start of human trials are projected for H1 2026. BetterLife is considering the development of BETR-001 for treatment of various psychiatric and neurological disorders. BetterLife Pharma Inc. is an emerging biotechnology company primarily focused on developing and commercializing two compounds, BETR-001 and BETR-002, to treat neuro-psychiatric and neurological disorders. BETR-001, which is in preclinical and IND-enabling studies, is a non-hallucinogenic neuroplastogen. BETR-001 is a non-controlled substance. BETR-001 will be developed for the treatment of various psychiatric and neurological disorders. BETR-001 pending patent, for composition and method of use, covers treatment of major depressive disorder, anxiety disorder and neuropathic pain and other neuro-psychiatric and neurological disorders. BETR-002, which is in preclinical and IND-enabling studies, is based on honokiol, the active anxiolytic ingredient of magnolia bark. BetterLife’s pending method of use and formulations patent covers treatment of anxiety-related disorders including benzodiazepine dependency. BetterLife also owns a drug candidate for the treatment of viral infections and is in the process of seeking strategic alternatives for further development. The content above comes from the network. if any infringement, please contact us to modify.

来自加州大学旧金山分校等机构的科学家们进行了一项开创性的研究，探索一种通常存在于某些蘑菇中的天然化合物—裸盖菇素（psilocybin）是否能够帮助治疗那些饱受情绪障碍困扰的帕金森病患者。 在医学研究的奇妙世界里，有时会有一些意想不到的发现。 近日，一篇发表在国际杂志Neuropsychopharmacology上题为“Psilocybin therapy for mood dysfunction in Parkinson's disease: an open-label pilot trial”的研究报告中，来自加州大学旧金山分校等机构的科学家们进行了一项开创性的研究，探索一种通常存在于某些蘑菇中的天然化合物——裸盖菇素（psilocybin）是否能够帮助治疗那些饱受情绪障碍困扰的帕金森病患者，这些患者不仅有运动功能障碍，还常常伴有抑郁和焦虑，而传统的抗抑郁药物往往对他们效果不佳。 帕金森病是一种以运动功能障碍为特征的神经退行性疾病，影响着约100万美国人，尽管像左旋多巴这样的药物能缓解疾病症状，但目前还没有能够减缓或逆转疾病进程的治疗方法；而情绪障碍在帕金森病中非常普遍，且与患者的功能衰退密切相关，甚至比运动症状更能预测患者的生活质量。因此寻找新的治疗方法对于改善帕金森病患者的生活质量至关重要。 研究结果令人惊喜，参与者不仅能很好地耐受这种药物，而且没有出现严重的副作用或症状加重，且在药物代谢完后数周，其机体的情绪、认知和运动功能都得到了显著改善，这不仅是首次将致幻剂用于任何神经退行性疾病患者的临床试验，也为帕金森病的治疗带来了新的曙光。 近年来，致幻剂在医学领域的研究逐渐成为热点，裸盖菇素作为一种具有潜在抗抑郁和抗焦虑效果的化合物，已经在治疗重度抑郁症和晚期癌症患者的情绪障碍方面显示出初步的积极效果。然而对于帕金森病等神经退行性疾病患者来说，这还是一个未知的领域。 在这项开放标签试验中，12名患有轻度至中度帕金森病且伴有抑郁和/或焦虑的参与者接受了裸盖菇素治疗，参与者首先接受了10毫克的裸盖菇素剂量，两周后接受了25毫克的更高剂量。治疗过程中，参与者还接受了总共八次的心理治疗来帮其更好地处理和理解裸盖菇素带来的体验。 研究的主要目标是评估裸盖菇素在帕金森病患者中的安全性和耐受性，同时也对情绪、认知和运动功能的潜在改善进行了初步评估。在治疗过程中，虽然几乎所有参与者都经历了一些不良事件，如焦虑、恶心和血压升高，但这些不良事件都不需要医疗干预。 安全性、耐受性和初步疗效结果 更令人惊喜的是，参与者在治疗后一周和一个月的随访中，情绪、认知和运动症状都得到了显著改善，这些改善不仅在短期内显现，而且在三个月后的评估中，情绪改善仍然显著。这一发现表明，裸盖菇素不仅能被帕金森病患者耐受，还可能对其机体的多种症状产生长期的积极影响。 研究人员提出了几种可能的解释来说明裸盖菇素如何改善帕金森病患者的症状。一种理论是裸盖菇素对患者情绪的积极影响可能导致了更好的认知和运动功能，比如当人们感觉更好时，其更有可能社交和参与活动，这两者都是帕金森病治疗的关键要素。另一种理论是，裸盖菇素可能通过减少炎症和促进神经可塑性（大脑细胞的生长和重新连接）来缓解疾病的多种症状。这些大脑细胞参与情绪、认知和运动调节，因此裸盖菇素或会通过多种机制来改善帕金森病患者的症状。 这项初步研究的结果非常有希望，促使研究人员开展了一项更大规模的随机对照试验。这项新研究将招募更多样化的患者群体，并纳入非侵入性脑刺激、神经影像学和其它工具来了解裸盖菇素如何影响炎症和神经可塑性。同时该研究还将在耶鲁大学设立第二个研究点，目标是招募 100 名参与者。 研究负责人 Joshua Woolley 博士表示，大多数脑部疾病仍然缺乏能够改变疾病进程的干预措施，我们通常可以治疗症状，但无法改变疾病轨迹或阻止病情恶化。如今这种情况开始发生变化，这些结果令人兴奋地表明，裸盖菇素可能有助于大脑自我修复。 综上，这项开创性的研究不仅为帕金森病患者带来了新的希望，也为神经退行性疾病的治疗提供了新的方向。随着更多研究的开展，我们期待能更深入地了解裸盖菇素的潜力并将其转化为实际的治疗方法，从而改善更多患者的生活质量。（生物谷Bioon.com） 参考文献： Bradley, E.R., Sakai, K., Fernandes-Osterhold, G. et al. Psilocybin therapy for mood dysfunction in Parkinson’s disease: an open-label pilot trial. Neuropsychopharmacol. (2025). doi：10.1038/s41386-025-02097-0