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.
開發大麻類治療產品和迷幻藥物的澳大利亞生物製藥公司IncanneX Healthcare(納斯達克股票代碼:IXHL)宣佈,其評估裸蓋菇素輔助心理療法治療廣泛性焦慮症的專有臨床試驗的第二階段臨床試驗達到了中期里程碑,並已開始數據分析。
這項研究是與莫納什大學臨床迷幻實驗室負責人和IncanneX科學顧問委員會成員保羅·利克納伊茨基博士合作領導的,旨在評估該公司的裸蓋菇素計劃的安全性和有效性,以及精神和身體健康的其他方面。
為期10周的治療計劃包括用裸蓋菇素或活性安慰劑進行兩次劑量治療。到目前為止,已有45名參與者參加了這項研究,29名參與者現在已經完成了治療方案和治療後的主要結果評估,沒有觀察到安全問題。
該臨時數據的評估將由一個獨立的數據安全監測委員會(DSMB)進行。IncanneX將使用隨後的建議來決定其監管戰略,並計劃關鍵研究,同時繼續從這項第二階段試驗中收集數據(招募正在進行中,以完成目標為72名患者的隊列。)
IncanneX繼續受益於莫納什大學和利克納伊茨基博士為這種療法的開發帶來的學術嚴謹,這將有助於我們成為世界上首批向公眾提供專有迷幻療法的公司之一的雄心。我們期待著根據DSMB的建議向我們的利益相關者提供進一步的最新情況,該公司的首席財務官梅克·布萊克利博士說。
圖片:Benzinga編輯與YAKOBCHUK Viacheslav和Alexander_Volkov在Shutterstock上的照片。