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Incannex Healthcare Inc. - IXHL STOCK NEWS

Welcome to our dedicated page for Incannex Healthcare news (Ticker: ixhl), a resource for investors and traders seeking the latest updates and insights on Incannex Healthcare stock.

Incannex Healthcare Limited (Nasdaq: IXHL) is a clinical stage pharmaceutical company dedicated to developing innovative medical cannabis products for the treatment of several major health conditions, including Obstructive Sleep Apnea (OSA), Traumatic Brain Injury (TBI)/Concussion, Rheumatoid Arthritis, Inflammatory Bowel Disease, and Inflammatory Lung Conditions. The company holds an Australian license to import, export, and distribute medicinal cannabis products and has launched a diverse line of cannabinoid-based products.

Incannex recently announced the commencement of patient dosing in a Phase 2 clinical trial for their proprietary combination drug candidate, IHL-675A. This drug, composed of Hydroxychloroquine Sulphate (HCQ) and cannabidiol (CBD), is designed to treat rheumatoid arthritis (RA). The trial aims to measure pain and function improvement over a 24-week period using the RAPID-3 assessment. 128 participants across 10 study sites in Australia will be part of this double-blind study, with some receiving IHL-675A, CBD, HCQ, or a placebo.

Chief Scientific Officer Dr. Mark Bleackley highlighted the trial as a significant milestone, emphasizing that RA affects millions globally and that IHL-675A has the potential to meet unmet needs in this area. The trial includes regular monitoring through blood tests, physical exams, and MRI scans to assess joint inflammation and damage.

Previously, in 2022 and 2023, Incannex successfully conducted a Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of IHL-675A. The results showed that the drug was well tolerated with no serious adverse events, indicating its potential as a viable treatment option. Interestingly, the trial pointed out that the uptake of CBD in IHL-675A might be faster than the reference drug Epidiolex, while the uptake of HCQ might be slower compared to Plaquenil. This could offer patients quicker relief from inflammation and extended relief from pain.

Through their ongoing projects and trials, Incannex Healthcare is positioning itself as a leader in the pharmaceutical industry, focusing on the potential benefits of cannabinoids and psychedelic medicine therapies for unmet medical needs.

For more detailed information, visit the official Incannex website or follow the latest news updates related to the company's progress and innovations.

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Incannex Healthcare has commenced patient dosing in its Phase 2/3 RePOSA clinical trial to assess the safety and efficacy of IHL-42X in treating obstructive sleep apnea (OSA). This trial is significant as it follows a successful Phase 2A study that showed a greater than 50% reduction in the apnea hypopnea index (AHI) at low doses, with 25% of patients achieving over 80% reduction. The trial will span 52 weeks, involving 560 patients across the US, EU, and UK, and aims to provide an alternative to CPAP machines which many patients find intolerable. If successful, IHL-42X could address a large unmet medical need and create substantial commercial and shareholder value.

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Incannex Healthcare Inc. (Nasdaq: IXHL) successfully completed a pre-IND meeting with the FDA for CannQuit-O, a treatment for Opioid Use Disorder. The FDA provided recommendations on the clinical development strategy, patient populations, efficacy endpoints, and safety monitoring. This milestone marks progress towards opening an IND for the product.

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Stonegate Healthcare Partners has released a report on potentially transformative therapies for Generalized Anxiety Disorder (GAD), aiming to improve patients' quality of life. The report highlights leading programs by companies like Mindmed, Incannex (NASDAQ: IXHL), and Compass Pathways. The global market for GAD treatment is projected to exceed $4 billion by 2033, with a 9% CAGR from 2023 onwards.

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Incannex Healthcare Inc. provides a quarterly update for Q1 2024, highlighting progress in their pharmaceutical development programs for cannabinoid products and psychedelic therapies. Key projects include IHL-42X for Obstructive Sleep Apnea, IHL-675A for Rheumatoid Arthritis, and PsiGAD for Generalised Anxiety Disorder. The company is focused on advancing clinical trials, preparing for FDA submissions, and opening Clarion Clinics for psychedelic-assisted therapies.
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Incannex Healthcare Inc. (Nasdaq: IXHL) announces positive Phase 2 results for psilocybin in generalised anxiety disorder. The PsiGAD1 trial achieved its primary endpoint with a significant HAM-A reduction of 12.8 points, surpassing expectations. Psilocybin group showed 44% improvement and 27% remission rate, far exceeding placebo. Psilocybin was well-tolerated with no severe adverse events. IND application for Phase 2B trial submitted to FDA.
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Incannex Healthcare Inc. (Nasdaq: IXHL) successfully completes pre-IND meeting with the FDA for CannQuit-N, a tobacco smoking cessation drug, receiving positive feedback and guidance for clinical trial design and manufacturing strategies.
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Incannex Healthcare Inc (Nasdaq: IXHL) is pleased to announce that Clarion Clinic’s Head of Psychiatry, Professor Suresh Sundram, has been approved by the TGA to prescribe MDMA for Post-traumatic Stress Disorder and psilocybin for Treatment-resistant Depression. The clinic in Melbourne is now open and represents Australia’s leading track record in psychedelic-assisted therapies. The TGA down-scheduled MDMA and psilocybin for use in the treatment of PTSD and TRD, permitting their use in clinical service delivery through the Authorised Prescriber Scheme.
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Incannex Healthcare Inc. (Nasdaq: IXHL) has announced the commencement of patient dosing in the Phase 2 clinical trial for IHL-675A, a combination drug candidate for rheumatoid arthritis. The trial aims to assess pain and function relative to baseline and will enroll 128 participants across 10 study sites in Australia. IHL-675A is a proprietary combination of Hydroxychloroquine Sulphate and cannabidiol, with well-characterized anti-inflammatory activity. The trial will monitor safety and efficacy outcomes, including inflammatory biomarkers and joint inflammation and damage via MRI. IHL-675A is a potential treatment for other inflammatory conditions such as inflammatory bowel disease, COPD, and asthma.
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Incannex Healthcare Inc. completed dosing and treatment protocols for all 72 participants in the PsiGAD-1 clinical trial evaluating its psilocybin treatment program for patients with generalized anxiety disorder. The company anticipates topline results within Q1 2024 and is well-advanced in the FDA IND application process. An independent documentary covering Monash Clinical Psychedelic Lab and PsiGAD research program will be released by SBS television network in late February 2024.
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Incannex Healthcare Inc. (Nasdaq: IXHL) has received IRB approval for the protocol of its Phase 2/3 clinical trial for the drug candidate IHL-42X to treat obstructive sleep apnea (OSA). The trial will assess safety and efficacy in OSA patients who are intolerant, non-compliant, or naïve to positive airway pressure (PAP). The study aims to recruit at least 560 patients across the United States, Germany, Spain, and Finland. The Phase 2/3 trial has already begun startup with 24 sites selected in the United States, 13 in Germany, 4 in Spain, and 2 in Finland. IHL-42X has shown promising results in a Phase 2 proof-of-concept study, reducing the apnea hypopnea index (AHI) by over 50% at the optimal dose, improving oxygen desaturation index, sleep efficiency, and patient-reported sleep quality.
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FAQ

What does Incannex Healthcare Limited do?

Incannex Healthcare Limited is a clinical stage pharmaceutical company developing medical cannabis products for the treatment of conditions such as OSA, TBI/Concussion, RA, Inflammatory Bowel Disease, and Inflammatory Lung Conditions.

What is IHL-675A?

IHL-675A is Incannex's proprietary combination drug candidate composed of Hydroxychloroquine Sulphate (HCQ) and cannabidiol (CBD), currently in Phase 2 clinical trials for rheumatoid arthritis.

What conditions is Incannex focusing on?

Incannex focuses on treating Obstructive Sleep Apnea (OSA), Traumatic Brain Injury (TBI)/Concussion, Rheumatoid Arthritis (RA), Inflammatory Bowel Disease, and Inflammatory Lung Conditions.

How is Incannex Healthcare positioned in the pharmaceutical industry?

Incannex Healthcare is positioned as an innovative leader in the pharmaceutical industry, focusing on the therapeutic benefits of cannabinoids and psychedelic medicine therapies for unmet medical needs.

What was the outcome of the Phase 1 clinical trial for IHL-675A?

The Phase 1 clinical trial for IHL-675A indicated that the drug was well tolerated with no serious adverse events, showing promising results for its safety and potential efficacy.

Where is Incannex Healthcare based?

Incannex Healthcare operates out of Melbourne, Australia, and has a presence in New York, USA.

What makes IHL-675A unique?

IHL-675A combines the anti-inflammatory properties of Hydroxychloroquine Sulphate (HCQ) and cannabidiol (CBD), potentially offering rapid and extended relief from inflammation and pain.

How can I invest in Incannex Healthcare Limited?

Investors can purchase shares of Incannex Healthcare Limited under the Nasdaq symbol IXHL.

What are the future plans for IHL-675A?

Future plans for IHL-675A include completing the Phase 2 clinical trial and submitting data for regulatory approval, including contributing to the FDA 505(b)2 new drug application dossier.

Who should consider IHL-675A as a treatment option?

IHL-675A is being developed for patients suffering from rheumatoid arthritis and potentially other inflammatory conditions such as inflammatory bowel disease and chronic obstructive pulmonary disease (COPD).

Incannex Healthcare Inc.

Nasdaq:IXHL

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