#IHL# - 61澳洲财经资讯

Two major events from IHL’s psychedelic Psi-GAD clinical trial program – US FDA PIND meeting & ethics approval

Psychedelic and cannabinoid biotech company, Incannex Healthcare Limited (ASX: IHL) today brings about the two exciting updates regarding its world 1st clinical trial program - psilocybin-assisted psychotherapy for Generalised Anxiety Disorder (Psi-GAD clinical trial): the Phase 2a Psi-GAD clinical trial has been approved by MUHREC; and the pre-IND with US FDA received positive, constructive, and supportive feedback.

药物开发公司Incannex宣布其Psi-GAD研究已获伦理批准并从FDA的研究前新药申请会议收到积极反馈

大麻药物开发公司Incannex Healthcare Limited (ASX：IHL) 宣布其Psi-GAD (裸盖菇素+心理疗法治疗广泛性焦虑症) 的2a期临床试验已获伦理批准并从与美国食品和药物管理局 (FDA) 的研究前新药申请 (pre-IND) 会议中收到积极反馈。试验患者招募预计于2022年初开始。

Procaps to manufacture IHL-42X soft gel capsules for Incannex as clinical trial nears conclusion

Clinical stage medical cannabis and psychedelic biotech company, Incannex Healthcare Limited (ASX: IHL) has engaged Procaps S.A. (Procaps), to manufacture IHL-42X soft gel capsules in preparation for its pivotal and ongoing open label clinical trials as it pursues FDA approval for the doctor prescribing market.

大麻药物开发公司Incannex与Procaps合作生产IHL-42X软凝胶胶囊

大麻药物开发公司Incannex Healthcare Limited (ASX: IHL) 宣布已聘请世界领先药品公司Procaps S.A. ("Procaps") 为其用于治疗阻塞性睡眠呼吸暂停 (OSA) 的大麻素组合药物IHL-42X开发和生产软凝胶胶囊，以为其正在进行的关键的开放标签临床试验做准备，并支持后续的FDA申请。

Incannex Healthcare files with the SEC for proposed US IPO on Nasdaq to make IHL dual listed

Incannex Healthcare Limited (ASX: IHL) announced that it had filed its Form F-1 registration statement with the US Securities and Exchange Commission, as part of its plan to dual list its shares on both ASX and Nasdaq.

Incannex (ASX:IHL) 正式向SEC提交Form 1申请在纳斯达克上市

临床阶段制药公司Incannex Healthcare Limited (ASX: IHL) 向公众宣布其已向美国证券交易委员会 (SEC) 提交上市注册声明表Form-1，促进该公司在澳洲证券交易所 (ASX) 和纳斯达克 (Nasdaq) 的双重上市计划。

Incannex就其广泛性焦虑障碍 (GAD) 2a期临床研究提交伦理审批和美国FDA研究性新药前会议申请

临床阶段药物开发公司Incannex Healthcare Limited (ASX: IHL) 今日宣布，已向人类研究伦理委员会 (HREC) 和美国药监局FDA提交其广泛性焦虑障碍 (GAD) 2a期临床研究的提案和研究性新药前会议 (IND) 申请。

Incannex submits HREC proposal and FDA pre-IND meeting request for Psi-GAD psilocybin therapy for Generalised Anxiety Disorder

Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) announced today that it has submitted the Human Research ETHICS Committee (‘HREC’) proposal and the US FDA pre-IND meeting request for its phase 2a clinical study for Generalised Anxiety Disorder (‘GAD’).

临床阶段药物开发公司Incannex发布6月季度报告，6项药物试验同时进行

临床阶段药物开发公司Incannex Healthcare Limited (ASX: IHL)提供其截至2020年6月30日的季度活动报告和附录4C。IHL正在同时进行最终目标是通过美国食品和药物管理局 (FDA) 的6个项目，这些临床药物是注入大麻配方的候选要和致幻剂药物。此外，IHL宣布停止其大麻油的销售业务。

Incannex开始多用途候选药物IHL-675A 1期人体临床试验，国际专利审查员评论该治疗方法“新颖和创造性”

大麻素和致幻剂药物开发公司Incannex Healthcare Limited (ASX: IHL) 已启动1期人体临床试验，以评估其多用途候选药物IHL- 675A软胶囊的安全性。这项研究将在阿德莱德的CMAX临床研究中心进行，由澳大利亚临床研究组织 (CRO) Avance Clinical负责领导。