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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

治疗FXS症状的迷幻药:即将进行的第二阶段临床试验的新研究合同
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.

迷幻药公司幸福数字科学公司(场外交易代码:KONEF)的子公司KGK科学公司已经与总部位于加拿大的生物技术公司签订了研究服务协议Nova Mentis生命科学公司(场外交易代码:NMLSF)首次进行裸盖菇素微剂量改善与遗传障碍相关的行为和认知症状的第二阶段临床试验脆性X综合征(FXS)FXS是一种遗传性疾病,会导致一系列发育问题,包括学习障碍和认知障碍。

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.

这笔交易预计KGK将负责提供研究服务,包括制定临床试验方案、监管和伦理提交、进行试验、数据管理和验证、统计分析和起草最终报告。

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.

这项临床研究将在加拿大安大略省伦敦市的KGK研究中心进行。这项小型开放标签试验将用于支持Nova Mentis在2021年底收到的FDA孤儿药物指定下的药物开发计划。

"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."

诺华计划对FXS进行裸盖菇素治疗,这对我们公司来说是一个重要的药物开发里程碑。威廉·拉斯坎,总裁,Nova Mentis首席执行官。我们相信,KGK在高质量临床研究试验方面的丰富经验和该领域的专家监管支持将使我们在成功治疗ASD和FXS方面取得相当大的进展,这两种疾病目前尚未得到满足。“

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的首席执行官纳吉拉·格思里他补充道:“我们很高兴能与Nova Mentis合作进行他们计划中的第二阶段临床试验。在过去的25年里,我们成功地帮助了数百家公司进行了定制设计的临床试验,并声称实施了有效地将产品推向全球市场的证实策略。”

Photo courtesy of Geralt on Pixabay.

照片由Geralt在Pixabay上提供。

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