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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.
生物技術藥物研發公司Mindset Pharma Inc.(場外交易代碼:MSSTF)開發治療神經精神和神經疾病的下一代迷幻和非迷幻藥物。為了追求他們的目標,它得到了來自英國藥品和保健品監管局(MHRA)關於幾個問題關於其第一階段臨牀試驗計劃的具體化評估該公司領先的迷幻藥候選藥物,MSP-1014,用於治療重度抑鬱障礙。
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之間的會議集中討論了該公司對其第二代裸蓋菇素類化合物,將在與英國專業合同研究機構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同意該公司的處置,同時也確認MSP-1014將不需要額外的臨牀前研究,前提是它獲得了國家臨牀試驗授權書。
Further, the agency provided scientific guidance on a potential clinical trial design in terms of dosing, patient selection criteria and safety issues.
此外,該機構為潛在的臨牀試驗設計提供了科學指導。在劑量、患者選擇標準和安全問題方面。
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.
至於正在研究的藥物,MSP-1014顯示出更好的療效和安全性,與臨牀前研究中的裸蓋菇素相比,具有更少的潛在副作用、更快的起效和相似的持續時間。
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的首席執行官詹姆斯·蘭蒂耶他説:“我們很高興收到MHRA的這份有利的書面指導,確認MSP-1014已準備好用於人類第一階段的臨牀開發。”
"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.
我們一直在努力推動MSP-1014通過監管程序和有了這一指導,我們向臨牀試驗又邁出了重要的一步,目前將不需要進行額外的臨牀前安全性研究。這就省去了昂貴和耗時的步驟。
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."
該公司預計,將他們的主要候選藥物推向人體試驗,“將有助於Mindset的目標,即接觸到患有精神健康疾病的患者,這些患者正在等待有意義的益處的新藥。”
As for additional drugs under development, the company has recently discovered three novel non-tryptamine psychedelic compounds, constituting their Families 6, 7 and 8.
至於正在開發的其他藥物,該公司最近發現了三種新的非色胺迷幻化合物,組成了它們的家族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.公司提供的金融資訊和交易應用程式。
在美國,moomoo上的投資產品和服務由Moomoo Financial Inc.提供,一家受美國證券交易委員會(SEC)監管的持牌主體。 Moomoo Financial Inc.是金融業監管局(FINRA)和證券投資者保護公司(SIPC)的成員。
在新加坡,moomoo上的投資產品和服務是通過Moomoo Financial Singapore Pte. Ltd.提供,該公司受新加坡金融管理局(MAS)監管(牌照號碼︰CMS101000) ,持有資本市場服務牌照 (CMS) ,持有財務顧問豁免(Exempt Financial Adviser)資質。本內容未經新加坡金融管理局的審查。
在澳大利亞,moomoo上的金融產品和服務是通過Futu Securities (Australia) Ltd提供,該公司是受澳大利亞證券和投資委員會(ASIC)監管的澳大利亞金融服務許可機構(AFSL No. 224663)。請閱讀並理解我們的《金融服務指南》、《條款與條件》、《隱私政策》和其他披露文件,這些文件可在我們的網站 https://www.moomoo.com/au中獲取。
在加拿大,透過moomoo應用程式提供的僅限訂單執行的券商服務由Moomoo Financial Canada Inc.提供,並受加拿大投資監管機構(CIRO)監管。
在馬來西亞,moomoo上的投資產品和服務是透過Moomoo Securities Malaysia Sdn. Bhd. 提供,該公司受馬來西亞證券監督委員會(SC)監管(牌照號碼︰eCMSL/A0397/2024) ,持有資本市場服務牌照 (CMSL) 。本內容未經馬來西亞證券監督委員會的審查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd.,Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc和Moomoo Securities Malaysia Sdn. Bhd., 是關聯公司。
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