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
澳大利亞墨爾本，2024年4月16日（GLOBE NEWSWIRE）——臨床階段藥物開發公司Incannex Healthcare Inc.（納斯達克股票代碼：IXHL）（“Incannex” 或 “公司”）很高興提供截至2024年3月31日的季度活動最新情況。
Incannex正在開展美國食品藥品監督管理局（“FDA”）針對大麻素藥品和迷幻藥物療法的各種研發（“研發”）計劃。公司治療產品線中最接近市場的項目是：
- IHL-42X 阻塞性睡眠呼吸暫停（“OSA”）候選藥物-2/3 期研究正在進行中。
- 類風溼關節炎（“RA”）的 IHL-675A 候選藥物-2b 期研究也在進行中。
- PSI-GAD psilocybin治療廣泛性焦慮症的方案：2b期研究是在成功對73名患者進行2期概念驗證研究後開始的。
- Clarion Clinics-在監管允許的地點開設第一家提供迷幻輔助心理治療的診所。
IHL-42X 用於治療阻塞性睡眠呼吸暫停
IHL-42X 是 Incannex 專有的固定劑量複方藥物，包括屈大麻酚和乙酰唑胺，用於治療 OSA，睡眠時呼吸道受阻。這種梗阻會導致氧氣吸收減少、睡眠質量差，並增加因睏倦或認知障礙導致的心臟病、心理健康障礙和意外事故的風險。OSA的當前護理標準是氣道正壓（“PAP”）設備，但是，由於患者不適，患者對PAP機器的依從性受到限制。目前尚無經批准的OSA藥物，IHL-42X 旨在滿足這種未得到滿足的需求，特別是對於對PAP 機器不耐受的患者。
RepoSA 2/3 期臨床試驗
美國食品和藥物管理局爲2023年啓動的多地點2/3期臨床試驗提供了許可。該試驗的名稱爲 repoSA，源自《揭示 IHL-42X 對OSA患者的療效》，將評估 IHL-42X 與成分活性藥物成分、屈大麻酚和乙酰唑胺以及安慰劑相比的安全性和有效性。
RepoSA 研究的設計包括一項第二階段劑量範圍研究，該研究將在美國的二十五個地點進行。2 期研究的患者將接受兩劑 IHL-42X 或安慰劑中的一劑，爲期 4 周。治療 4 周後，患者將使用隔夜多導睡眠圖進行評估，以確定其睡眠呼吸暫停的嚴重程度，以及患者報告的各種預後和血液樣本採集，以確定 IHL-42X 對他們的睡眠質量和 IHL-42X 安全性的影響。
該研究的第三階段部分將把試驗範圍擴大到歐洲的地點，將治療期延長至一年，並將比較第二階段最佳劑量的 IHL-42X 與成分活性藥物成分、屈大麻酚和乙酰唑胺以及安慰劑。該研究已在 clinicaltrials.gov 上註冊，NCT 編號爲 NCT06146101。
在本季度，Incannex專注於爲第二階段的患者給藥做準備，並取得了以下成果：
- RepoSA研究已選擇了所有25個位於美國的2期試驗地點（“研究地點”）。這些站點處於不同的啓動階段，如下所示：
- 與 20 個站點簽訂的合同。
- 16 個站點已獲得機構審查委員會 (“IRB”) 的全面批准。
- 美國食品和藥物管理局的IND中增加了11名研究人員。
- IHL-42X 藥物產品已製造並運往美國的一個倉庫，將從那裏分發到各個地點。藥品抵達現場後不久將開始給患者服藥。
該試驗第三階段的準備工作與第二階段的啓動活動同時進行。入選第二階段試驗的25個美國研究中心也將參與第三階段。第 2 階段和第 3 階段的組件包含在已獲得 IRB 批准的單一協議中。第三階段試驗還將包括德國、西班牙、芬蘭和英國的研究基地。本季度第三階段的進展包括：
- 已爲第三階段選擇了所有其他30個場地。這包括德國的16個站點、西班牙的7個站點、芬蘭的2個站點和英國（“英國”）的5個站點。
- 批准在歐洲進行這項研究的歐盟CTR一攬子計劃已接近敲定和提交。
Incannex Inc.總裁兼首席執行官喬爾·萊瑟姆表示：“目前沒有FDA或EMA註冊的治療睡眠呼吸暫停的藥物，我們認爲這是Incannex爲患者提供沒有直接市場競爭對手的新型治療選擇的重大機會。”
“在OSA患者中調查IHL-42X 的初始2期概念驗證臨床試驗顯示，AHI平均降低了50.7％，25％的受試者的AHI降低了超過80％。重要的是，我們還觀察到患者平均氧氣去飽和指數下降了59.7％，患者報告的睡眠質量明顯改善。”
這些結果確實非常了不起，促進了我們對2/3期試驗的投資。如果我們在3期試驗的52周內再次觀察到如此顯著的藥物療效，Incannex相信我們的產品將上市。”
IHL-42X 生物利用度/生物等效性研究
Incannex打算使用505（b）2途徑向美國食品藥品管理局提交 IHL-42X 固定劑量複方藥物的新藥申請（“保密協議”）。505（b）2保密協議允許申請人通過先前批准的參考上市藥物，依賴來自非Incannex進行的研究的有關成分藥物物質的信息。之前獲得美國食品藥品管理局批准的參考藥物，屈大麻酚和乙酰唑胺，對應於 IHL-42X 中的活性藥物成分。
要使用 FDA505 (b) 2 途徑，IHL-42X 中活性藥物成分的藥代動力學必須直接與列出的參考藥物進行比較。正在進行生物利用度/生物等效性（“BA/BE”）研究，以評估 IHL-42X 的生物利用度並確定所列參考藥物的生物等效性。
BA/BE 研究正在取得進展，旨在招募至少 116 名健康志願者，他們每人將在禁食條件下接受單劑量的 IHL-42X、屈大麻酚和乙酰唑胺，在餵食條件下接受 IHL-42X。每種藥物服用後，患者將在48小時內在規定的時間點採集血液樣本。將對這些血液樣本進行屈大麻酚、乙酰唑胺及其相關代謝物分析。這些數據將用於確定藥物及其代謝物的藥代動力學參數。在整個研究過程中，還將對參與者進行監測，以收集有關 IHL-42X 安全性的更多數據。該研究已在 clinicaltrials.gov 上註冊，NCT 編號爲 NCT05857384。
本季度繼續招募患者，共有72名參與者被隨機分配，並在試驗中接受了至少一劑疫苗。迄今爲止，尚未發生嚴重的不良事件。爲了加快研究速度，又增加了一個地點，第二個地點的篩查已經開始。
用於治療炎症性疾病的 IHL-675A
IHL-675A 是 Incannex 專有的固定劑量複方藥物，用於治療慢性炎性疾病。當人體的免疫系統攻擊自身的組織和器官導致炎症、疼痛、不適和受損組織時，就會發生炎症性疾病。IHL-675A 是一種針對類風溼關節炎、炎症性腸病（結腸炎和克羅恩氏病）和肺部炎症（慢性阻塞性肺病、哮喘、支氣管炎和急性呼吸綜合徵）的多用途抗炎藥物。IHL-675A 是註冊藥物羥氯喹和大麻二酚（“CBD”）的組合，Incannex已在臨床前研究中觀察到其協同抗炎活性。
Incannex 目前的重點是開發用於治療類風溼關節炎（“RA”）的 IHL-675A，類風溼關節炎是一種主要影響關節的炎症性疾病。儘管有各種經批准的類風溼關節炎治療方法，但這些療效通常有限或存在安全問題，導致許多類風溼關節炎患者繼續感到疼痛，從而降低了他們的生活質量。HCQ 通常爲 RA 患者開處方。IHL-675A 旨在通過添加 CBD 和與 HCQ 的協同活性來提供額外的治療活性，緩解與 RA 相關的疼痛患者。
調查類風溼關節炎患者的 IHL-675A 的 2 期臨床試驗
這項2期臨床試驗將包括至少128名關節炎參與者，無論目前的治療狀況如何，他們都因疾病而感到疼痛和功能減退。參與者被隨機分配到 4 個組中的一個：要麼是 IHL-675A，要麼單獨使用 CBD，要麼單獨使用 HCQ，要麼是安慰劑。該試驗的主要終點是相對於基線的疼痛和功能，根據 24 周的 RAPID3 評估分數確定。
參與者還使用電子患者報告結果（PRO）設備完成有關疼痛、疲勞、關節僵硬和生活質量的問卷，每天記錄他們的疼痛和功能預後。參與者將參加每月對臨床試驗場所的訪問，血液檢查和體格檢查將監測其他安全性和有效性結果，包括炎症生物標誌物。該研究已在 clinicaltrials.gov 上註冊，NCT 編號爲 NCT05942911。
患者給藥於本季度開始。該試驗的其他進展包括：
- 所有十個試用站點均已完成試點啓動
- 篩查正在進行中
- 迄今爲止，沒有報告嚴重的不良事件。
psIGad 用於治療廣泛性焦慮症
psIGad是Incannex針對廣泛性焦慮症（“GAD”）的迷幻藥相關心理治療藥物。GAD 是一種相對常見但嚴重的精神疾病，在一生中會影響大約 4-6% 的人口。GAD 會嚴重影響生活質量和職業前景。GAD 治療的國際指南建議選擇性血清素再攝取抑制劑（'SSRIs'）、血清素和去甲腎上腺素再攝取抑制劑（'snRIs'）以及普瑞巴林作爲一線選擇，地西泮等苯二氮卓類藥物作爲二線選擇。GAD 也可以單獨通過心理治療或與藥物療法聯合治療。但是，這些傳統療法的療效有限，不到一半的患者在接受這些治療後得到緩解，而且治療副作用和費用都很高。
psigad1 — 2A 期概念驗證臨床試驗的結果
在本季度，Incannex公佈了在澳大利亞墨爾本莫納什大學進行的psIGAD1臨床試驗的主要結果。在迷幻藥組中，漢密爾頓焦慮評級量表（“HAM-A”）分數從基線下降了12.8分，從基線的29.5分降至第11周（最後一次給藥後6周）的16.8分。在迷幻藥組中觀察到的HAM-A評分下降幅度比安慰劑組觀察到的下降高9.2分（-12.8 psilocybin對比-3.6安慰劑；p<0.0001）。
進一步的分析顯示，psilocybin組中有44％的患者被觀察到具有臨床意義的改善，焦慮評分比基線降低了至少50％；“反應率” 是安慰劑組的四倍以上。psilocybin組中有27％的患者實現了完全的疾病緩解；這一比率是使用安慰劑進行心理治療的五倍。據觀察，psiGad心理治療背景下的迷幻藥耐受性良好，僅報告了輕度和中度不良事件（AE）。報告的AE與該藥物的已知作用一致。未觀察到嚴重或嚴重的不良事件。
psigad2 正在開啓的 2B 期臨床試驗
名爲Psychennex的Incannex子公司開始爲PSIGad計劃準備美國食品藥品管理局研究性新藥（“IND”）申請。psIGAD1研究的結果正在納入IND檔案，同時還將完成其他模塊的定稿，爲提交給美國食品藥品管理局做準備。本季度IND檔案工作包括：
- Incannex 的迷幻藥品 PSX-001 的配方開發說明以及相關的質量和穩定性數據。
- 關於迷幻藥治療GAD的安全性和有效性的臨床和非臨床數據摘要。
- 與總部位於英國的專門從事精神病學和中樞神經系統治療的合同研究組織Clerkenwell Health敲定臨床試驗方案和其他研究文件。
IND的開放臨床試驗將在美國和英國的研究中心進行。在準備IND檔案的同時，Incannex和Psychennex一直在與Clerkenwell合作，準備向藥品和保健產品監管局（“MHRA”）提交相應的文件，以便在英國的試驗場所進行試驗。
Clarion 診所
Clarion Clinics是專門爲迷幻輔助治療提供最佳環境而設計和裝修的。第一家運營診所擁有七間治療室和一間團體治療室，是商業規模的原型，能夠在正常工作時間內每年爲大約 600 人提供治療，在延長工作時間內可治療更多患者。Clarion Clinics在本季度開始接收首批患者，預計該手術的首批收入將在本季度出現。其他診所正在規劃中，預計規模將超過最初的診所。
對開設診所的初步反應強烈，迄今已有500多名潛在患者表示對治療感興趣。Clarion組建了一支世界一流的臨床領導團隊，擁有澳大利亞經驗最豐富的迷幻輔助療法臨床交付團隊。根據澳大利亞治療用品管理局（TGA）的下調計劃，Clarion可以通過分別使用****和迷幻藥來增強專科心理治療，從而治療創傷後應激障礙（PTSD）和耐藥性抑鬱症（TRD）患者。
本公告已獲Incannex董事會批准向納斯達克發佈。
關於 Incannex 醫療保健公司
Incannex是一家臨床階段的藥物開發公司，正在開發獨特的藥用大麻藥物和迷幻藥物療法，用於治療阻塞性睡眠呼吸暫停（OSA）、創傷性腦損傷（TBI）和腦震盪、肺部炎症（ARDS、COPD、哮喘、支氣管炎）、類風溼性關節炎、炎症性腸病、焦慮症、成癮障礙和疼痛等適應症。
正在爲每種在研藥物和療法尋求美國食品和藥物管理局的批准和註冊，但須視持續的臨床成功情況而定。目前正在調查的每種適應症都沒有或有限的現有註冊藥物療法（藥物）治療可供公衆使用，這對Incannex及其股東來說是重大的全球經濟機遇。
Incannex在與醫療和科學顧問委員會及合作伙伴共同開發產品和療法時制定了強有力的專利申請戰略。該公司擁有19項已獲授權的專利和30項待批准的專利申請。Incannex 在納斯達克以 IXHL 的名義上市
網站：
投資者：investors@incannex.com.au
前瞻性陳述
本新聞稿包含1995年《美國私人證券訴訟改革法》“安全港” 條款所指的 “前瞻性陳述”。這些前瞻性陳述自首次發佈之日起作出，基於當前的預期和估計以及管理層的信念和假設。本新聞稿中包含的前瞻性陳述代表了截至本新聞稿發佈之日Incannex的觀點。Incannex預計，隨後的事件和發展可能會導致其觀點發生變化。Incannex無意或有義務更新或修改任何前瞻性陳述，無論是由於新信息、未來事件還是其他原因造成的。在本新聞稿發佈之日後的任何日期，均不應將這些前瞻性陳述視爲代表Incannex的觀點。
聯繫信息：
Incannex 醫療保健公司
喬爾·萊瑟姆先生
首席執行官、總裁兼董事
admin@incannex.com.au
投資者關係聯繫人—美國
萊恩·揚克
愛迪生集團
+1 (610) 716 2868
lyonker@edisongroup.com
