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Mindset Pharma Meets With UK Regulator: Is A Phase 1 Trial Getting Close?
Mindset Pharma Meets With UK Regulator: Is A Phase 1 Trial Getting Close?
Biotech drug discovery firm Mindset Pharma Inc. (OTCQB:MSSTF) develops next-generation psychedelic and non-psychedelic medicines for neuropsychiatric and neurological disorders. To pursue their goal it received scientific advice from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on several matters regarding the concretion of its first Phase 1 clinical trial plan evaluating the company's lead psychedelic drug candidate, MSP-1014, for the treatment of major depressive disorder.
The meeting between the MHRA and Mindset focused on discussing the company's plans for the Phase 1 trial of their second-generation psilocybin-like compound, to be developed in collaboration with specialized UK-based contract research organization Clerkenwell Health.
The MHRA agreed with the company's dispositions while also confirming that MSP-1014 would not require additional preclinical studies, provided it receives the national Clinical Trial Authorization.
Further, the agency provided scientific guidance on a potential clinical trial design in terms of dosing, patient selection criteria and safety issues.
As for the drug under study, MSP-1014 demonstrated greater efficacy and safety profiles, with reduced potential side effects, faster onset and similar duration of effect compared to the psilocybin in preclinical studies.
Mindset's CEO James Lanthier expressed: "We are thrilled to have received this favorable written guidance from the MHRA, confirming the readiness of MSP-1014 for Phase 1 first-in-human clinical development."
"We have been working diligently to advance MSP-1014 through the regulatory process and with this guidance, we have taken yet another essential step toward clinical trials and will not be required to conduct additional preclinical safety studies at this time, which removes costly and time consuming steps," he further explained.
The company expects that advancing their lead drug candidate forward to human trials "will contribute to Mindset's goal of reaching patients suffering with mental health conditions who are waiting for new medicines with meaningful benefits."
As for additional drugs under development, the company has recently discovered three novel non-tryptamine psychedelic compounds, constituting their Families 6, 7 and 8.
Photo courtesy of Olia Danilevich on Pexels.
Biotech drug discovery firm Mindset Pharma Inc. (OTCQB:MSSTF) develops next-generation psychedelic and non-psychedelic medicines for neuropsychiatric and neurological disorders. To pursue their goal it received scientific advice from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on several matters regarding the concretion of its first Phase 1 clinical trial plan evaluating the company's lead psychedelic drug candidate, MSP-1014, for the treatment of major depressive disorder.
生物技术药物研发公司Mindset Pharma Inc.(场外交易代码:MSSTF)开发治疗神经精神和神经疾病的下一代迷幻和非迷幻药物。为了追求他们的目标,它得到了来自英国药品和保健品监管局(MHRA)关于几个问题关于其第一阶段临床试验计划的具体化评估该公司领先的迷幻药候选药物,MSP-1014,用于治疗重度抑郁障碍。
The meeting between the MHRA and Mindset focused on discussing the company's plans for the Phase 1 trial of their second-generation psilocybin-like compound, to be developed in collaboration with specialized UK-based contract research organization Clerkenwell Health.
MHRA和Mindset之间的会议集中讨论了该公司对其第二代裸盖菇素类化合物,将在与英国专业合同研究机构Clerkenwell Health合作。
The MHRA agreed with the company's dispositions while also confirming that MSP-1014 would not require additional preclinical studies, provided it receives the national Clinical Trial Authorization.
MHRA同意该公司的处置,同时也确认MSP-1014将不需要额外的临床前研究,前提是它获得了国家临床试验授权书。
Further, the agency provided scientific guidance on a potential clinical trial design in terms of dosing, patient selection criteria and safety issues.
此外,该机构为潜在的临床试验设计提供了科学指导。在剂量、患者选择标准和安全问题方面。
As for the drug under study, MSP-1014 demonstrated greater efficacy and safety profiles, with reduced potential side effects, faster onset and similar duration of effect compared to the psilocybin in preclinical studies.
至于正在研究的药物,MSP-1014显示出更好的疗效和安全性,与临床前研究中的裸盖菇素相比,具有更少的潜在副作用、更快的起效和相似的持续时间。
Mindset's CEO James Lanthier expressed: "We are thrilled to have received this favorable written guidance from the MHRA, confirming the readiness of MSP-1014 for Phase 1 first-in-human clinical development."
Mindset的首席执行官詹姆斯·兰蒂耶他说:“我们很高兴收到MHRA的这份有利的书面指导,确认MSP-1014已准备好用于人类第一阶段的临床开发。”
"We have been working diligently to advance MSP-1014 through the regulatory process and with this guidance, we have taken yet another essential step toward clinical trials and will not be required to conduct additional preclinical safety studies at this time, which removes costly and time consuming steps," he further explained.
我们一直在努力推动MSP-1014通过监管程序和有了这一指导,我们向临床试验又迈出了重要的一步,目前将不需要进行额外的临床前安全性研究。这就省去了昂贵和耗时的步骤。
The company expects that advancing their lead drug candidate forward to human trials "will contribute to Mindset's goal of reaching patients suffering with mental health conditions who are waiting for new medicines with meaningful benefits."
该公司预计,将他们的主要候选药物推向人体试验,“将有助于Mindset的目标,即接触到患有精神健康疾病的患者,这些患者正在等待有意义的益处的新药。”
As for additional drugs under development, the company has recently discovered three novel non-tryptamine psychedelic compounds, constituting their Families 6, 7 and 8.
至于正在开发的其他药物,该公司最近发现了三种新的非色胺迷幻化合物,组成了它们的家族6、7和8。
Photo courtesy of Olia Danilevich on Pexels.
照片由Olia Danilevich在Pexels上提供。
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
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