MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Inc. (NASDAQ: IXHL), ('Incannex' or the 'Company'), is pleased to provide quarterly activities update and for the quarter ended 31 March 2024.
Incannex is undertaking various U.S. Food and Drug Administration ('FDA') research and development ('R&D') programs for cannabinoid pharmaceutical products and psychedelic medicine therapies. The nearest-to-market projects in the Company's therapeutic pipeline are:
- IHL-42X drug candidate for Obstructive Sleep Apnea ('OSA') - Phase 2/3 studies underway.
- IHL-675A drug candidate for Rheumatoid Arthritis ('RA') - Phase 2b studies also underway.
- Psi-GAD psilocybin treatment protocol for generalised anxiety disorder: Phase 2b studies commencing following successful Phase 2 proof of concept studies in 73 patients.
- Clarion Clinics - opens first clinic for the provision of psychedelic-assisted psychotherapies in regulatory permissible locations.
IHL-42X for Treatment of Obstructive Sleep Apnea
IHL-42X is Incannex's proprietary fixed dose combination drug comprising dronabinol and acetazolamide for treatment of OSA, a condition in which a person's airways are obstructed during sleep. That obstruction results in reduced oxygen uptake, poor-quality sleep and higher risk of heart disease, mental health disorders and accidents due to sleepiness or cognitive impairment. The current standard of care for OSA are positive airway pressure ('PAP') devices, however, patient compliance with PAP machines is limited due to patient discomfort. There are no approved drugs for OSA and IHL-42X is designed to fill this unmet need, particularly for patients who are intolerant to PAP machines.
The RePOSA Phase 2/3 Clinical Trial
The FDA provided clearance for the multi-site Phase 2/3 IND opening clinical trial in 2023. The trial, which has been given the name RePOSA, derived from Revealing the Efficacy of IHL-42X use in Patients with OSA, will assess the safety and efficacy of IHL-42X compared to the component active pharmaceutical ingredients, dronabinol and acetazolamide, as well as placebo.
Design of the RePOSA study consists of a Phase 2 dose ranging study that will be conducted at twenty-five sites in the United States. Patients in the Phase 2 study will receive one of two doses of IHL-42X or placebo for 4 weeks. After 4 weeks treatment, the patients will undergo assessment using overnight polysomnography to determine the severity of their sleep apnea, as well as various patient-reported outcomes and blood sample collection to determine the effects of IHL-42X on their sleep quality and the safety of IHL-42X.
The Phase 3 component of the study will expand the trial to sites in Europe, extend the treatment period to 1 year, and will compare IHL-42X at the optimal dose from Phase 2 to the component active pharmaceutical ingredients, dronabinol and acetazolamide, as well as placebo. The study is registered on clinicaltrials.gov with NCT number NCT06146101.
During the quarter, Incannex focused on preparing for patient dosing in Phase 2 and achieved the following:
- All 25 US based Phase 2 trial sites ('sites') have been selected for the RePOSA study. The sites are at various stages of start-up, as follows:
- Contracts executed with 20 sites.
- 16 sites have full Institutional Review Board ('IRB') approval.
- 11 investigators have been added to the FDA IND.
- The IHL-42X drug product has been manufactured and shipped to a depot in the US, from where it will be distributed to sites. Arrival of drug product at sites will be followed shortly by commencement of patient dosing.
Preparation for the Phase 3 component of the trial is being undertaken in parallel with start-up activities for Phase 2. The 25 US sites selected for the Phase 2 component of the trial will also participate in Phase 3. The Phase 2 and Phase 3 components are contained within a single protocol that has already been approved by the IRB. The Phase 3 trial will also include sites in Germany, Spain, Finland, and the UK. Progress towards Phase 3 in the quarter included:
- All 30 additional sites have been selected for Phase 3. This consists of 16 sites in Germany, 7 in Spain, 2 in Finland and 5 in the United Kingdom ('UK').
- EU-CTR package for approval to conduct the study in Europe is nearing finalisation and submission.
President and CEO Incannex Inc., Mr Joel Latham said, "There are no FDA or EMA registered drugs for the treatment of sleep apnea, which we believe represents a major opportunity for Incannex to provide patients with a novel treatment option with no direct market competitors."
"The initial Phase 2 proof of concept clinical trial investigating IHL-42X in patients with OSA demonstrated an average reduction in AHI of 50.7%, with 25% of subjects having a reduced AHI of >80%. Importantly, we also observed a reduction in average patient oxygen desaturation index of 59.7% and markedly improved patient reported sleep quality."
These results were truly remarkable and has facilitated our investment in the Phase 2/3 trial. If we again observe such notable drug efficacy, safely administered over the 52 weeks of the Phase 3 component of the trial, Incannex is confident that our product will be marketable."
The IHL-42X Bioavailability/Bioequivalence Study
Incannex intends to submit a New Drug Application ('NDA') for IHL-42X fixed dose combination drug to the FDA using the 505(b)2 pathway. The 505(b)2 NDA permits an applicant to rely on information on the component drug substances, via previous approved reference listed drugs, from studies not conducted by Incannex. The previously FDA-approved reference drugs, dronabinol and acetazolamide, correspond to the active pharmaceutical ingredients in IHL-42X.
To use the FDA505(b)2 pathway, the pharmacokinetics of the active pharmaceutical ingredients in IHL-42X must compared directly to the reference listed drugs. The Bioavailability/Bioequivalence ('BA/BE') study is being undertaken to assess the bioavailability of IHL-42X and determine the bioequivalence to the reference listed drugs.
The BA/BE study is progressing and aims to recruit at least 116 healthy volunteers who will each receive a single dose of IHL-42X, dronabinol and acetazolamide under fasted conditions, as well as IHL-42X under fed conditions. After each drug is administered, patients will have blood samples collected at defined timepoints over 48 hours. These blood samples will be analysed for dronabinol, acetazolamide and their relevant metabolites. This data will be used to determine pharmacokinetic parameters for the drugs and their metabolites. Participants will also be monitored throughout the study to collect additional data on the safety of IHL-42X. The study is registered on clinicaltrials.gov with NCT number NCT05857384.
Patient recruitment continued during the quarter, a total of 72 participants have been randomised and received a minimum of one dose in the trial. No serious adverse events have occurred to date. An additional site has been added to hasten the study and screening has commenced at the second site.
IHL-675A for Treatment of Inflammatory Diseases
IHL-675A is Incannex's proprietary fixed dose combination drug for the treatment of chronic inflammatory diseases. Inflammatory conditions occur when the body's immune system attacks its own tissues and organs causing inflammation, pain, discomfort, and damage to the affected tissues. IHL-675A is a multi-use, anti-inflammatory drug targeting rheumatoid arthritis, inflammatory bowel disease (colitis and Crohn's disease) and lung inflammation (COPD, asthma, bronchitis, and ARDS). IHL-675A is a combination of hydroxychloroquine ('HCQ'), a registered pharmaceutical, and cannabidiol ('CBD'), for which Incannex has observed synergistic anti-inflammatory activity in pre-clinical studies.
Incannex's current focus is on developing IHL-675A for treatment of rheumatoid arthritis ('RA'), an inflammatory condition that predominantly affects the joints. Although there are various approved treatments for RA, these often have limited efficacy or come with safety concerns, resulting in many RA patients continuing to experience pain, which reduces their quality of life. HCQ is commonly prescribed to patients with RA. IHL-675A is designed to provide additional therapeutic activity through the addition of CBD and the synergistic activity with HCQ, providing relief to patients with pain associated with their RA.
Phase 2 clinical trial investigating IHL-675A in patients with Rheumatoid Arthritis
This Phase 2 clinical trial will include a minimum of 128 participants with RA who are experiencing pain and reduced function resulting from their disease, regardless of current treatment status. Participants are randomized to one of 4 arms: either IHL-675A, CBD alone, HCQ alone or placebo. The primary endpoint for the trial is pain and function relative to baseline, determined via the score on the RAPID3 assessment at 24 weeks.
Participants also record their pain and function outcomes daily, by completing questionnaires on pain, fatigue, joint stiffness and quality of life, using an electronic Patient Reported Outcomes (PRO) device. The participants will attend monthly visits at the clinical trial site, where blood tests, and physical examinations will monitor additional safety and efficacy outcomes, including inflammatory biomarkers. The study is registered on clinicaltrials.gov with NCT number NCT05942911.
Patient dosing commenced during the quarter. Other progress in the trial has included:
- Site initiation completed at all ten trial sites
- Screening ongoing
- No serious adverse events reported to date.
PsiGAD for Treatment of Generalised Anxiety Disorder
PsiGAD is Incannex's psilocybin associated psychotherapy treatment for generalised anxiety disorder ('GAD'). GAD is a relatively common, but serious psychiatric condition affecting around 4-6% of the population during their lifetime. GAD can severely affect quality of life and professional career prospects. International guidelines for GAD treatment recommend selective serotonin reuptake inhibitors ('SSRIs'), serotonin and noradrenaline reuptake inhibitors ('SNRIs'), and pregabalin as first-line options, with benzodiazepines such as diazepam as second-line options. GAD is also treated with psychotherapy alone, or in combination with pharmacotherapies. However, these traditional treatments show limited efficacy, with less than half of patients achieving remission following these treatments and substantial treatment side-effects and cost.
PsiGAD1 – Results from Phase 2A Proof of Concept Clinical Trial
During the quarter, Incannex released top line results from the PsiGAD1 clinical trial conducted at Monash University, based in Melbourne, Australia. The reduction in Hamilton Anxiety Ratings Scale ('HAM-A') score from baseline in the psilocybin group was 12.8 points, from 29.5 at baseline, to 16.8 at week 11 (6 weeks following the final dosing session). This reduction in HAM-A score observed in the psilocybin group was 9.2 points greater than the reduction observed in the placebo group (-12.8 psilocybin vs. -3.6 placebo; p<0.0001).
Further analysis revealed that 44% of patients in the psilocybin group were observed to have a clinically meaningful improvement of at least 50% reduction in anxiety score from baseline; a 'response rate' more than four times higher than that of the placebo group. 27% of patients in the psilocybin group achieved full disease remission; a rate five times higher than that of psychotherapy with placebo. Psilocybin within the context of PsiGAD psychotherapy was observed to be well-tolerated, with only mild and moderate adverse events (AEs) reported. The reported AEs were consistent with the known effects of the drug. No serious or severe adverse events were observed.
PsiGAD2 IND-opening Phase 2B Clinical Trial
Incannex subsidiary, called Psychennex, commenced preparing an FDA Investigational New Drug ('IND') application for the PsiGAD program. The results of the PsiGAD1 study are being incorporated into the IND dossier along with finalization of the other modules in preparation for submission to the FDA. Work on the IND dossier during the quarter includes:
- Description of the formulation development of Incannex's psilocybin drug product PSX-001 along with relevant quality and stability data.
- Summaries of clinical and non-clinical data on the safety and efficacy of psilocybin for the treatment of GAD.
- Finalisation of the clinical trial protocol and other study documents with Clerkenwell Health, a UK based contract research organization specializing in psychiatry and central nervous system treatments.
The IND opening clinical trial will be conducted at sites in the US and the UK. In parallel with the preparation of the IND dossier, Incannex and Psychennex have been working with Clerkenwell to prepare the corresponding submission to the Medicines and Healthcare products Regulatory Agency ('MHRA'), to allow for conduct of the trial at sites in the UK.
Clarion Clinics
Clarion Clinics has been designed and fitted out specifically to provide the optimal environment for psychedelic-assisted therapy. With seven treatments rooms and a group therapy room, the first operational clinic is a commercial scale prototype and has the capacity to treat approximately 600 people per year in normal working hours and substantially more in extended hour operations. Clarion Clinics started to receive its first patients during the quarter and first revenues from the operation are expected in the current quarter. Other clinics are being planned and expected to be larger than the initial clinic.
Initial response to the clinic opening has been strong with over 500 potential patients expressing an interest in treatment to date. Clarion has assembled a world class clinical leadership team and has the most experienced clinical delivery team for psychedelic-assisted therapy in Australia. Clarion, per the Australian Therapeutic Goods Administration (TGA) down-scheduling, can treat patients with post-traumatic stress disorder (PTSD) and treatment resistant depression (TRD) by augmenting specialist psychotherapy with MDMA and psilocybin, respectively.
This announcement has been approved for release to NASDAQ by the Incannex Board of Directors.
About Incannex Healthcare Inc.
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of obstructive sleep apnoea (OSA), traumatic brain injury (TBI) and concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis, inflammatory bowel disease, anxiety disorders, addiction disorders, and pain, among other indications.
U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication under investigation currently has no, or limited, existing registered pharmacotherapy (drug) treatments available to the public and represent major global economic opportunities to Incannex and its shareholders.
Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. The Company holds 19 granted patents and 30 pending patent applications. Incannex is listed on the NASDAQ as IXHL
Website:
Investors: investors@incannex.com.au
Forward-looking statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex's views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex's views as of any date after the date of this press release.
Contact Information:
Incannex Healthcare Inc.
Mr Joel Latham
Chief Executive Officer, President and Director
admin@incannex.com.au
Investor Relations Contact – United States
Laine Yonker
Edison Group
+1 (610) 716 2868
lyonker@edisongroup.com
澳大利亚墨尔本,2024年4月16日(GLOBE NEWSWIRE)——临床阶段药物开发公司Incannex Healthcare Inc.(纳斯达克股票代码:IXHL)(“Incannex” 或 “公司”)很高兴提供截至2024年3月31日的季度活动最新情况。
Incannex正在开展美国食品药品监督管理局(“FDA”)针对大麻素药品和迷幻药物疗法的各种研发(“研发”)计划。公司治疗产品线中最接近市场的项目是:
- IHL-42X 阻塞性睡眠呼吸暂停(“OSA”)候选药物-2/3 期研究正在进行中。
- 类风湿关节炎(“RA”)的 IHL-675A 候选药物-2b 期研究也在进行中。
- PSI-GAD psilocybin治疗广泛性焦虑症的方案:2b期研究是在成功对73名患者进行2期概念验证研究后开始的。
- Clarion Clinics-在监管允许的地点开设第一家提供迷幻辅助心理治疗的诊所。
IHL-42X 用于治疗阻塞性睡眠呼吸暂停
IHL-42X 是 Incannex 专有的固定剂量复方药物,包括屈大麻酚和乙酰唑胺,用于治疗 OSA,睡眠时呼吸道受阻。这种梗阻会导致氧气吸收减少、睡眠质量差,并增加因困倦或认知障碍导致的心脏病、心理健康障碍和意外事故的风险。OSA的当前护理标准是气道正压(“PAP”)设备,但是,由于患者不适,患者对PAP机器的依从性受到限制。目前尚无经批准的OSA药物,IHL-42X 旨在满足这种未得到满足的需求,特别是对于对PAP 机器不耐受的患者。
RepoSA 2/3 期临床试验
美国食品和药物管理局为2023年启动的多地点2/3期临床试验提供了许可。该试验的名称为 repoSA,源自《揭示 IHL-42X 对OSA患者的疗效》,将评估 IHL-42X 与成分活性药物成分、屈大麻酚和乙酰唑胺以及安慰剂相比的安全性和有效性。
RepoSA 研究的设计包括一项第二阶段剂量范围研究,该研究将在美国的二十五个地点进行。2 期研究的患者将接受两剂 IHL-42X 或安慰剂中的一剂,为期 4 周。治疗 4 周后,患者将使用隔夜多导睡眠图进行评估,以确定其睡眠呼吸暂停的严重程度,以及患者报告的各种预后和血液样本采集,以确定 IHL-42X 对他们的睡眠质量和 IHL-42X 安全性的影响。
该研究的第三阶段部分将把试验范围扩大到欧洲的地点,将治疗期延长至一年,并将比较第二阶段最佳剂量的 IHL-42X 与成分活性药物成分、屈大麻酚和乙酰唑胺以及安慰剂。该研究已在 clinicaltrials.gov 上注册,NCT 编号为 NCT06146101。
在本季度,Incannex专注于为第二阶段的患者给药做准备,并取得了以下成果:
- RepoSA研究已选择了所有25个位于美国的2期试验地点(“研究地点”)。这些站点处于不同的启动阶段,如下所示:
- 与 20 个站点签订的合同。
- 16 个站点已获得机构审查委员会 (“IRB”) 的全面批准。
- 美国食品和药物管理局的IND中增加了11名研究人员。
- IHL-42X 药物产品已制造并运往美国的一个仓库,将从那里分发到各个地点。药品抵达现场后不久将开始给患者服药。
该试验第三阶段的准备工作与第二阶段的启动活动同时进行。入选第二阶段试验的25个美国研究中心也将参与第三阶段。第 2 阶段和第 3 阶段的组件包含在已获得 IRB 批准的单一协议中。第三阶段试验还将包括德国、西班牙、芬兰和英国的研究基地。本季度第三阶段的进展包括:
- 已为第三阶段选择了所有其他30个场地。这包括德国的16个站点、西班牙的7个站点、芬兰的2个站点和英国(“英国”)的5个站点。
- 批准在欧洲进行这项研究的欧盟CTR一揽子计划已接近敲定和提交。
Incannex Inc.总裁兼首席执行官乔尔·莱瑟姆表示:“目前没有FDA或EMA注册的治疗睡眠呼吸暂停的药物,我们认为这是Incannex为患者提供没有直接市场竞争对手的新型治疗选择的重大机会。”
“在OSA患者中调查IHL-42X 的初始2期概念验证临床试验显示,AHI平均降低了50.7%,25%的受试者的AHI降低了超过80%。重要的是,我们还观察到患者平均氧气去饱和指数下降了59.7%,患者报告的睡眠质量明显改善。”
这些结果确实非常了不起,促进了我们对2/3期试验的投资。如果我们在3期试验的52周内再次观察到如此显著的药物疗效,Incannex相信我们的产品将上市。”
IHL-42X 生物利用度/生物等效性研究
Incannex打算使用505(b)2途径向美国食品药品管理局提交 IHL-42X 固定剂量复方药物的新药申请(“保密协议”)。505(b)2保密协议允许申请人通过先前批准的参考上市药物,依赖来自非Incannex进行的研究的有关成分药物物质的信息。之前获得美国食品药品管理局批准的参考药物,屈大麻酚和乙酰唑胺,对应于 IHL-42X 中的活性药物成分。
要使用 FDA505 (b) 2 途径,IHL-42X 中活性药物成分的药代动力学必须直接与列出的参考药物进行比较。正在进行生物利用度/生物等效性(“BA/BE”)研究,以评估 IHL-42X 的生物利用度并确定所列参考药物的生物等效性。
BA/BE 研究正在取得进展,旨在招募至少 116 名健康志愿者,他们每人将在禁食条件下接受单剂量的 IHL-42X、屈大麻酚和乙酰唑胺,在喂食条件下接受 IHL-42X。每种药物服用后,患者将在48小时内在规定的时间点采集血液样本。将对这些血液样本进行屈大麻酚、乙酰唑胺及其相关代谢物分析。这些数据将用于确定药物及其代谢物的药代动力学参数。在整个研究过程中,还将对参与者进行监测,以收集有关 IHL-42X 安全性的更多数据。该研究已在 clinicaltrials.gov 上注册,NCT 编号为 NCT05857384。
本季度继续招募患者,共有72名参与者被随机分配,并在试验中接受了至少一剂疫苗。迄今为止,尚未发生严重的不良事件。为了加快研究速度,又增加了一个地点,第二个地点的筛查已经开始。
用于治疗炎症性疾病的 IHL-675A
IHL-675A 是 Incannex 专有的固定剂量复方药物,用于治疗慢性炎性疾病。当人体的免疫系统攻击自身的组织和器官导致炎症、疼痛、不适和受损组织时,就会发生炎症性疾病。IHL-675A 是一种针对类风湿关节炎、炎症性肠病(结肠炎和克罗恩氏病)和肺部炎症(慢性阻塞性肺病、哮喘、支气管炎和急性呼吸综合征)的多用途抗炎药物。IHL-675A 是注册药物羟氯喹和大麻二酚(“CBD”)的组合,Incannex已在临床前研究中观察到其协同抗炎活性。
Incannex 目前的重点是开发用于治疗类风湿关节炎(“RA”)的 IHL-675A,类风湿关节炎是一种主要影响关节的炎症性疾病。尽管有各种经批准的类风湿关节炎治疗方法,但这些疗效通常有限或存在安全问题,导致许多类风湿关节炎患者继续感到疼痛,从而降低了他们的生活质量。HCQ 通常为 RA 患者开处方。IHL-675A 旨在通过添加 CBD 和与 HCQ 的协同活性来提供额外的治疗活性,缓解与 RA 相关的疼痛患者。
调查类风湿关节炎患者的 IHL-675A 的 2 期临床试验
这项2期临床试验将包括至少128名关节炎参与者,无论目前的治疗状况如何,他们都因疾病而感到疼痛和功能减退。参与者被随机分配到 4 个组中的一个:要么是 IHL-675A,要么单独使用 CBD,要么单独使用 HCQ,要么是安慰剂。该试验的主要终点是相对于基线的疼痛和功能,根据 24 周的 RAPID3 评估分数确定。
参与者还使用电子患者报告结果(PRO)设备完成有关疼痛、疲劳、关节僵硬和生活质量的问卷,每天记录他们的疼痛和功能预后。参与者将参加每月对临床试验场所的访问,血液检查和体格检查将监测其他安全性和有效性结果,包括炎症生物标志物。该研究已在 clinicaltrials.gov 上注册,NCT 编号为 NCT05942911。
患者给药于本季度开始。该试验的其他进展包括:
- 所有十个试用站点均已完成试点启动
- 筛查正在进行中
- 迄今为止,没有报告严重的不良事件。
psIGad 用于治疗广泛性焦虑症
psIGad是Incannex针对广泛性焦虑症(“GAD”)的迷幻药相关心理治疗药物。GAD 是一种相对常见但严重的精神疾病,在一生中会影响大约 4-6% 的人口。GAD 会严重影响生活质量和职业前景。GAD 治疗的国际指南建议选择性血清素再摄取抑制剂('SSRIs')、血清素和去甲肾上腺素再摄取抑制剂('snRIs')以及普瑞巴林作为一线选择,地西泮等苯二氮卓类药物作为二线选择。GAD 也可以单独通过心理治疗或与药物疗法联合治疗。但是,这些传统疗法的疗效有限,不到一半的患者在接受这些治疗后得到缓解,而且治疗副作用和费用都很高。
psigad1 — 2A 期概念验证临床试验的结果
在本季度,Incannex公布了在澳大利亚墨尔本莫纳什大学进行的psIGAD1临床试验的主要结果。在迷幻药组中,汉密尔顿焦虑评级量表(“HAM-A”)分数从基线下降了12.8分,从基线的29.5分降至第11周(最后一次给药后6周)的16.8分。在迷幻药组中观察到的HAM-A评分下降幅度比安慰剂组观察到的下降高9.2分(-12.8 psilocybin对比-3.6安慰剂;p<0.0001)。
进一步的分析显示,psilocybin组中有44%的患者被观察到具有临床意义的改善,焦虑评分比基线降低了至少50%;“反应率” 是安慰剂组的四倍以上。psilocybin组中有27%的患者实现了完全的疾病缓解;这一比率是使用安慰剂进行心理治疗的五倍。据观察,psiGad心理治疗背景下的迷幻药耐受性良好,仅报告了轻度和中度不良事件(AE)。报告的AE与该药物的已知作用一致。未观察到严重或严重的不良事件。
psigad2 正在开启的 2B 期临床试验
名为Psychennex的Incannex子公司开始为PSIGad计划准备美国食品药品管理局研究性新药(“IND”)申请。psIGAD1研究的结果正在纳入IND档案,同时还将完成其他模块的定稿,为提交给美国食品药品管理局做准备。本季度IND档案工作包括:
- Incannex 的迷幻药品 PSX-001 的配方开发说明以及相关的质量和稳定性数据。
- 关于迷幻药治疗GAD的安全性和有效性的临床和非临床数据摘要。
- 与总部位于英国的专门从事精神病学和中枢神经系统治疗的合同研究组织Clerkenwell Health敲定临床试验方案和其他研究文件。
IND的开放临床试验将在美国和英国的研究中心进行。在准备IND档案的同时,Incannex和Psychennex一直在与Clerkenwell合作,准备向药品和保健产品监管局(“MHRA”)提交相应的文件,以便在英国的试验场所进行试验。
Clarion 诊所
Clarion Clinics是专门为迷幻辅助治疗提供最佳环境而设计和装修的。第一家运营诊所拥有七间治疗室和一间团体治疗室,是商业规模的原型,能够在正常工作时间内每年为大约 600 人提供治疗,在延长工作时间内可治疗更多患者。Clarion Clinics在本季度开始接收首批患者,预计该手术的首批收入将在本季度出现。其他诊所正在规划中,预计规模将超过最初的诊所。
对开设诊所的初步反应强烈,迄今已有500多名潜在患者表示对治疗感兴趣。Clarion组建了一支世界一流的临床领导团队,拥有澳大利亚经验最丰富的迷幻辅助疗法临床交付团队。根据澳大利亚治疗用品管理局(TGA)的下调计划,Clarion可以通过分别使用摇头丸和迷幻药来增强专科心理治疗,从而治疗创伤后应激障碍(PTSD)和耐药性抑郁症(TRD)患者。
本公告已获Incannex董事会批准向纳斯达克发布。
关于 Incannex 医疗保健公司
Incannex是一家临床阶段的药物开发公司,正在开发独特的药用大麻药物和迷幻药物疗法,用于治疗阻塞性睡眠呼吸暂停(OSA)、创伤性脑损伤(TBI)和脑震荡、肺部炎症(ARDS、COPD、哮喘、支气管炎)、类风湿性关节炎、炎症性肠病、焦虑症、成瘾障碍和疼痛等适应症。
正在为每种在研药物和疗法寻求美国食品和药物管理局的批准和注册,但须视持续的临床成功情况而定。目前正在调查的每种适应症都没有或有限的现有注册药物疗法(药物)治疗可供公众使用,这对Incannex及其股东来说是重大的全球经济机遇。
Incannex在与医疗和科学顾问委员会及合作伙伴共同开发产品和疗法时制定了强有力的专利申请战略。该公司拥有19项已获授权的专利和30项待批准的专利申请。Incannex 在纳斯达克以 IXHL 的名义上市
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前瞻性陈述
本新闻稿包含1995年《美国私人证券诉讼改革法》“安全港” 条款所指的 “前瞻性陈述”。这些前瞻性陈述自首次发布之日起作出,基于当前的预期和估计以及管理层的信念和假设。本新闻稿中包含的前瞻性陈述代表了截至本新闻稿发布之日Incannex的观点。Incannex预计,随后的事件和发展可能会导致其观点发生变化。Incannex无意或有义务更新或修改任何前瞻性陈述,无论是由于新信息、未来事件还是其他原因造成的。在本新闻稿发布之日后的任何日期,均不应将这些前瞻性陈述视为代表Incannex的观点。
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Incannex 医疗保健公司
乔尔·莱瑟姆先生
首席执行官、总裁兼董事
admin@incannex.com.au
投资者关系联系人—美国
莱恩·扬克
爱迪生集团
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