Psychedelic Partnership To Test Psilocybin For FXS In First Phase 2 Clinical Trial
Psychedelic Partnership To Test Psilocybin For FXS In First Phase 2 Clinical Trial
Psychedelics biotechs Nova Mentis Life Science Corp. (OTCQB:NMLSF) and Wellbeing Digital Sciences Inc. (OTC:KONEF)'s subsidiary KGK Sciences Inc. have submitted the first-ever Phase 2a Clinical Trial Application (CTA) to test safety and efficacy of oral microdose of proprietary psilocybin NM-1001 for cognitive and behavioral symptoms associated with Fragile X Syndrome (FXS) to Health Canada.
迷幻生物技術Nova Mentis生命科學公司。(場外交易代碼:NMLSF)和幸福數字科學公司(場外交易代碼:KONEF)的子公司KGK Science Inc.向加拿大衞生部提交了有史以來第一份2a期臨牀試驗申請(CTA),以測試口服微劑量專有裸蓋菇素NM-1001治療與脆性X綜合徵(FXS)相關的認知和行為症狀的安全性和有效性。
FXS is the leading genetic cause of autism spectrum disorder (ASD), and NOVA is applying to commence the Phase 2 study via its partner and Contract Research Organization (CRO), KGK, while recently completing the production of its cGMP synthetic psilocybin 1.5 mg microdose capsules to be used in the trial.
FXS是自閉症譜系障礙(ASD)的主要遺傳原因,Nova正在申請通過其合作伙伴和合同研究組織(CRO)KGK開始第二階段研究,同時最近完成了試驗中使用的cGMP合成裸蓋菇素1.5 mg微劑量膠囊的生產。
NOVA's scientific advisory board chairman Dr. Marvin S. Hausman explained that the company's drug development plan "is to initially establish the therapeutic potential of repetitive low-dose psilocybin to adults with FXS to improve behavioral and cognitive symptoms."
Nova科學顧問委員會主席馬文·S·豪斯曼博士解釋説,該公司的藥物開發計劃“是初步確定重複小劑量裸蓋菇素對患有FXS的成年人的治療潛力,以改善行為和認知症狀。”
NOVA's president and CEO William Rascan further added that the study is "the first human clinical study of psilocybin for FXS," and that it is intended to support an orphan drug submission with both the U.S. FDA and European Medicines Agency.
諾瓦的總裁兼首席執行官威廉·拉斯坎他進一步補充説,這項研究是“第一次對裸蓋菇素用於FXS的人體臨牀研究”,它的目的是支持向美國FDA和歐洲藥品管理局提交孤兒藥物。
"We are confident that KGK's extensive experience in high-quality clinical research trials and expert regulatory support in the space will enable us to continue to make considerable progress towards successful treatment of ASD and FXS, currently unmet medical needs," Rascan said.
拉斯坎説:“我們相信,KGK在高質量臨牀研究試驗方面的豐富經驗和該領域的專家監管支持將使我們在成功治療ASD和FXS方面繼續取得相當大的進展,這兩種疾病目前尚未得到滿足。”
On behalf of Wellbeing and KGK, CEO Najla Guthrie agreed that it is "an exciting time" for both partners, and further added: "Over the past 25 years, we have successfully helped hundreds of companies with custom-designed clinical trials and claim substantiation strategies that move products efficiently into the global markets."
我代表惠康和KGK,首席執行官納吉拉·格思裏他一致認為,這對雙方來説都是“令人興奮的時刻”,並進一步補充説:“在過去的25年裏,我們成功地幫助了數百家公司進行了定製設計的臨牀試驗,並提出了證明戰略,將產品高效地推向全球市場。”
The CTA is subject to a 30-day review by Health Canada and, if approved, the partners intend to begin the open-label 10-patient study in early 2023.
CTA將接受加拿大衞生部為期30天的審查,如果獲得批准,合作伙伴打算在2023年初開始這項開放標籤的10名患者研究。
Photo courtesy of geralt and sergeitokmakov on Pixabay.
照片由Geralt和Sergeitokmakov在Pixabay提供。