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Psychedelics For FXS Symptoms: New Research Contract For Upcoming Phase 2 Clinical Trial

Psychedelics For FXS Symptoms: New Research Contract For Upcoming Phase 2 Clinical Trial

治療FXS症狀的迷幻藥:即將進行的第二階段臨牀試驗的新研究合同
Benzinga Real-time News ·  2022/11/17 14:52

Psychedelics company Wellbeing Digital Sciences Inc. (OTC:KONEF)'s subsidiary KGK Science Inc. has entered into a research services agreement with Canadian-based biotech Nova Mentis Life Science Corp. (OTC:NMLSF) for a first-of-its-kind Phase 2 clinical trial on psilocybin microdoses' efficacy to improve behavioral and cognitive symptoms associated with the genetic disorder Fragile X syndrome (FXS.) FXS is a genetic condition that causes a range of developmental problems including learning disabilities and cognitive impairment.

迷幻藥公司幸福數字科學公司(場外交易代碼:KONEF)的子公司KGK科學公司已經與總部位於加拿大的生物技術公司簽訂了研究服務協議Nova Mentis生命科學公司(場外交易代碼:NMLSF)首次進行裸蓋菇素微劑量改善與遺傳障礙相關的行為和認知症狀的第二階段臨牀試驗脆性X綜合徵(FXS)FXS是一種遺傳性疾病,會導致一系列發育問題,包括學習障礙和認知障礙。

The deal foresees KGK being in charge of providing research services, including the development of the clinical trial protocol, regulatory and ethics submissions, conducting the trial, data management and validation, statistical analysis and drafting the final report.

這筆交易預計KGK將負責提供研究服務,包括制定臨牀試驗方案、監管和倫理提交、進行試驗、數據管理和驗證、統計分析和起草最終報告。

The clinical study is set to be conducted at KGK's research center in London, Ontario, Canada. The small, open-label trial would be used to support Nova Mentis' drug development program under the FDA Orphan Drug designation received in late 2021.

這項臨牀研究將在加拿大安大略省倫敦市的KGK研究中心進行。這項小型開放標籤試驗將用於支持Nova Mentis在2021年底收到的FDA孤兒藥物指定下的藥物開發計劃。

"Nova's planned psilocybin treatment of FXS is a major drug development milestone for our company," stated William Rascan, president and CEO of Nova Mentis. "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 make considerable progress towards successful treatment of ASD and FXS, currently unmet medical needs."

諾華計劃對FXS進行裸蓋菇素治療,這對我們公司來説是一個重要的藥物開發里程碑。威廉·拉斯坎,總裁,Nova Mentis首席執行官。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方面取得相當大的進展,這兩種疾病目前尚未得到滿足。“

Wellbeing and KGK's CEO Najla Guthrie added: "We are thrilled to be working with Nova Mentis for their planned Phase 2 clinical trials. 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."

福祉和KGK的首席執行官納吉拉·格思裏他補充道:“我們很高興能與Nova Mentis合作進行他們計劃中的第二階段臨牀試驗。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,並聲稱實施了有效地將產品推向全球市場的證實策略。”

Photo courtesy of Geralt on Pixabay.

照片由Geralt在Pixabay上提供。

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