Australian biopharma company developing therapeutic cannabinoid products and psychedelic medicines Incannex Healthcare (NASDAQ:IXHL) announced that its Phase 2 clinical trial assessing proprietary psilocybin-assisted psychotherapy for Generalized Anxiety Disorder (GAD) treatment achieved its interim milestone and the analysis of the data has begun.
The study, led in collaboration with the head of the clinical psychedelic lab at Monash University and a member of the Incannex scientific advisory board Dr. Paul Liknaitzky, is set to assess safety and efficacy as well as additional aspects of mental and physical health of the company's psilocybin program.
The 10-week treatment program includes two dosing sessions with either psilocybin or an active placebo. To date, 45 participants have been enrolled in the study and 29 participants have now completed the treatment protocol and main outcome assessment following treatment, no safety issues observed.
The evaluation of this interim data will be conducted by an independent Data Safety Monitoring Board (DSMB). Incannex will use the consequent recommendations to decide on its regulatory strategy as well as plan pivotal studies while continuing to collect data from this Phase 2 trial (recruitment is ongoing towards completing the aimed 72 patients cohort.)
"Incannex continues to benefit from the academic rigor that Monash University and Dr. Liknaitzky bring to the development of this therapy, which should assist our ambitions to be amongst the first companies in the world to provide a proprietary psychedelic therapy to the public. We look forward to providing a further update to our stakeholders following the recommendations from the DSMB," said the company's CSO, Dr. Mark Bleackley.
Photo: Benzinga edit with photo by YAKOBCHUK VIACHESLAV and Alexander_Volkov on Shutterstock.
开发大麻类治疗产品和迷幻药物的澳大利亚生物制药公司IncanneX Healthcare(纳斯达克股票代码:IXHL)宣布,其评估裸盖菇素辅助心理疗法治疗广泛性焦虑症的专有临床试验的第二阶段临床试验达到了中期里程碑,并已开始数据分析。
这项研究是与莫纳什大学临床迷幻实验室负责人和IncanneX科学顾问委员会成员保罗·利克纳伊茨基博士合作领导的,旨在评估该公司的裸盖菇素计划的安全性和有效性,以及精神和身体健康的其他方面。
为期10周的治疗计划包括用裸盖菇素或活性安慰剂进行两次剂量治疗。到目前为止,已有45名参与者参加了这项研究,29名参与者现在已经完成了治疗方案和治疗后的主要结果评估,没有观察到安全问题。
该临时数据的评估将由一个独立的数据安全监测委员会(DSMB)进行。IncanneX将使用随后的建议来决定其监管战略,并计划关键研究,同时继续从这项第二阶段试验中收集数据(招募正在进行中,以完成目标为72名患者的队列。)
IncanneX继续受益于莫纳什大学和利克纳伊茨基博士为这种疗法的开发带来的学术严谨,这将有助于我们成为世界上首批向公众提供专有迷幻疗法的公司之一的雄心。我们期待着根据DSMB的建议向我们的利益相关者提供进一步的最新情况,该公司的首席财务官马克·布莱克利博士说。
图片:Benzinga编辑与YAKOBCHUK Viacheslav和Alexander_Volkov在Shutterstock上的照片。