iHub News
3月前
Incannex outlines dose-optimization study for sleep apnea treatmentMarch 12, 2026 11:42 AM
IH Market News
Incannex Healthcare Inc. (NASDAQ:IXHL) on Thursday detailed an updated clinical development plan for IHL-42X, its oral treatment candidate for obstructive sleep apnea, following results from its Phase 2 trial.The company said it intends to launch a Phase 2 crossover dose-optimization study known as DReAMzz, which will assess various ratios of the drug’s two active components, dronabinol and acetazolamide. According to a company press release, patient dosing is expected to begin within the next few months.IHL-42X has been granted Fast Track Designation by the U.S. Food and Drug Administration, enabling closer and more frequent engagement with the agency during the development process.Results from the completed RePOSA Phase 2 study showed that 33.3% of participants in the low-dose group and 41.2% in the high-dose group achieved more than a 30% reduction in the apnea-hypopnea index. In addition, 58% of patients reported an improvement in their obstructive sleep apnea symptoms, with roughly 90% of those respondents describing the improvement as meaningful in their daily lives. The trial reported no serious adverse events.“Following the strong, statistically significant outcomes from our Phase 2 RePOSA trial, we believe IHL-42X is emerging as one of the most promising oral therapies in development for obstructive sleep apnea,” said Joel Latham, President and Chief Executive Officer of Incannex Healthcare.Investors reacted positively to the news, sending the stock up nearly 49% over the past week to $5.97, although shares remain about 73% lower over the past year.The company said the planned optimization study aims to determine the formulation that delivers improvements in objective sleep and respiratory measures while preserving patient-reported benefits and the favorable safety profile observed in the Phase 2 trial.Incannex has appointed a contract research organization to oversee the DReAMzz study, and the findings are expected to support progression into a Phase 3 development program.Incannex is a clinical-stage biopharmaceutical company focused on developing combination therapies for chronic conditions such as obstructive sleep apnea, rheumatoid arthritis and generalized anxiety disorder. With a market capitalization of about $71 million, InvestingPro analysis suggests the stock is currently trading above its Fair Value. An InvestingPro Tip also indicates the company is burning through cash at a rapid pace, although it currently holds more cash than debt on its balance sheet.In other developments, Incannex Healthcare Inc. recently announced a 1-for-30 reverse stock split of its common shares, approved by the company’s board of directors. The move is intended to maintain compliance with Nasdaq listing requirements. The shares will trade on a split-adjusted basis under a new CUSIP number while retaining the existing ticker symbol.The company has also expanded its Clinical Advisory Board with the addition of three experts—Murray B. Stein, MD, MPH; Andrew Cutler, MD; and Amir Kalali, MD—to support development of its PSX-001 program targeting generalized anxiety disorder. The advisory board was established to provide independent clinical and scientific guidance as the program advances into its next stage.Additionally, during its 2025 Annual Meeting of Stockholders, Incannex elected Dr. George Anastassov and Robert Clark to its board of directors, both receiving strong shareholder support. The company’s shareholders also approved the ratification of its external auditor. These developments reflect Incannex’s ongoing strategic and operational initiatives.Incannex Healthcare stock price
Original: Incannex outlines dose-optimization study for sleep apnea treatment
iHub News
4月前
Incannex approves 1-for-30 reverse stock split to regain Nasdaq complianceFebruary 25, 2026 10:26 AM
IH Market News
Incannex Healthcare Inc. (NASDAQ:IXHL) announced Monday that its board of directors has authorized a 1-for-30 reverse stock split of the company’s common shares, according to a company press release.The reverse split will become effective at 4:01 p.m. Eastern Time on Thursday, with trading set to begin on a split-adjusted basis the following Friday under the existing ticker symbol IXHL. The shares will trade with a new CUSIP number, 45333F 208, on The Nasdaq Capital Market.The move is intended to raise the company’s per-share trading price in order to meet Nasdaq’s minimum bid price requirement for continued listing. The stock currently trades around $0.27 and has declined roughly 81% over the past year, falling from a 52-week high of $1.66 to a low of $0.08. According to an InvestingPro tip, the shares have exhibited significant volatility, with a beta of 2.59 indicating greater price swings than the broader market. Shareholders previously approved the reverse split during a special meeting held on May 27, 2025.Under the 1-for-30 ratio, every 30 existing shares will be consolidated into one new share. The number of outstanding shares will decrease from approximately 358,329,368 as of February 20, 2026, to about 11,944,313 shares, while the total number of authorized shares will remain unchanged.Investors holding positions that are not evenly divisible by the split ratio will receive an additional fractional share rounded up to the nearest whole share, with no cash payments issued for fractions.Corresponding adjustments will be made to exercise prices and share counts tied to outstanding equity awards, as well as to securities issued or available under the company’s stock incentive plan.Shareholders holding stock electronically in book-entry form do not need to take action, while positions held through brokers, banks or other nominees will be automatically adjusted.Incannex is a clinical-stage pharmaceutical company focused on developing combination therapies targeting conditions such as obstructive sleep apnea, rheumatoid arthritis and generalized anxiety disorder. The company has a market capitalization of approximately $98.18 million and carries a “WEAK” overall financial health score on InvestingPro, which provides additional analytical insights into the company’s outlook.In separate developments, Incannex recently received Fast Track designation from the U.S. Food and Drug Administration for its obstructive sleep apnea candidate IHL-42X, following encouraging results from three clinical trials, including the Phase 2 “RePOSA” study that demonstrated meaningful reductions in the Apnea-Hypopnea Index. The company has also expanded its Clinical Advisory Board to support development of its PSX-001 program for generalized anxiety disorder, appointing three independent experts for clinical and scientific guidance.At the corporate governance level, Incannex held its 2025 Annual Meeting of Stockholders, during which Dr. George Anastassov and Robert Clark were elected as directors. The meeting was later adjourned due to a quorum shortfall caused by an administrative issue, with plans to reconvene in January 2026.Incannex Healthcare stock price
Original: Incannex approves 1-for-30 reverse stock split to regain Nasdaq compliance
longtrailer
7月前
New guideline establishes clinical recommendations for sleep apnea in hospitalized adults.
https://aasm.org/new-guideline-establishes-clinical-recommendations-for-sleep-apnea-in-hospitalized-adults/
DARIEN, IL – A new clinical practice guideline is the first from the American Academy of Sleep Medicine to provide recommendations for the management of obstructive sleep apnea in medically hospitalized adults.
Available online as an accepted paper in the Journal of Clinical Sleep Medicine, the guideline fills an existing gap in clinical practice and addresses an area of growing concern. Previously published data show that sleep-disordered breathing is associated with a 17% increased length of stay for nonsurgical, hospitalized patients, and it is associated with a 67% increase in hospitalization costs.
“The existing clinical paradigm for the diagnosis, management and treatment of obstructive sleep apnea has focused on the outpatient arena, so guidance for inpatients has been lacking,” said lead author Dr. Reena Mehra, chair of the AASM task force that developed the guideline and head of the division of pulmonary, critical care and sleep medicine at University of Washington Medicine in Seattle. “While there will be marked variations in hospital and institutional resources to screen, diagnose and treat sleep apnea, these recommendations serve as a guide to move the field forward in prioritizing systematic approaches to manage sleep apnea in the inpatient setting.”
It is estimated that 54 million adults in the U.S. have obstructive sleep apnea, a chronic disease that involves repeated collapse of the upper airway during sleep. Sleep apnea is commonly treated with positive airway pressure (PAP) therapy, which uses mild levels of air pressure, provided through a mask, to keep the airway open during sleep.
All four clinical recommendations in the guideline are designated as “conditional,” meaning that they reflect a lower degree of certainty and require the clinician to use clinical judgment while considering the patient’s values and preferences to determine the best course of action. These recommendations support:
Inpatient screening of obstructive sleep apnea in high-risk patients as part of an integrated evaluation and management pathway
Use of PAP therapy in those with moderate to severe sleep apnea who are currently untreated
Sleep medicine consultation for those with increased risk of sleep apnea or established sleep apnea
Discharge plans for management of sleep apnea with a goal to minimize loss to follow-up
The guideline also emphasizes that adults with an established diagnosis of sleep-disordered breathing should continue their existing treatment while in the hospital, unless contraindicated. In addition to PAP therapy, treatments for sleep apnea include oral appliance therapy and upper airway stimulation therapy.
While the authors acknowledged that the availability of hospital-based sleep medicine consultations will vary by location, they indicated that the preference is to have oversight by a board-certified sleep medicine physician and involvement of the sleep team at an AASM-accredited sleep center. This involvement can include consultations facilitated using telehealth tools.
To develop the guideline, the AASM commissioned a task force of sleep medicine physicians with expertise in the management of hospitalized adults with sleep apnea. They crafted clinical practice recommendations based on a systematic review of the literature and an assessment of the evidence according to the GRADE process, taking into consideration the certainty of evidence, beneficial and harmful effects, patient values and preferences, and resource use. The draft guideline was posted for public comment, and the AASM board of directors approved the final recommendations.
This guideline was endorsed by the Alliance of Sleep Apnea Partners, American Association for Respiratory Care, American Association of Sleep Technologists, American Society for Metabolic and Bariatric Surgery, American Thoracic Society, Project Sleep, Society of Anesthesia and Sleep Medicine, and the Wellness, Sleep, and Circadian Network. The American Academy of Otolaryngology–Head and Neck Surgery and its foundation and the American Society of Anesthesiologists affirmed the value of this guideline.
The co-authors of the guideline are Dr. Dennis Auckley, Dr. Karin Johnson, Dr. Martha Billings, Gerard Carandang, Dr. Yngve Falck-Ytter, Dr. Rami Khayat, Dr. Reem Mustafa, Dr. Cinthya Pena-Orbea, Dr. Ashima Sahni, Dr. Sunil Sharma, and Dr. Susheel Patil.
View more AASM clinical practice guidelines and learn more about the guideline development process.
###
To arrange an interview with Dr. Mehra or an AASM spokesperson, please contact the AASM at media@aasm.org. Accepted papers, which are published online prior to their final inclusion in an issue of the journal, are not embargoed. The guideline was posted as an accepted paper on Aug. 21 and is scheduled to be published in the December issue of the Journal of Clinical Sleep Medicine.
About the American Academy of Sleep Medicine
Established in 1975, the AASM is a medical association that advances sleep care and enhances sleep health to improve lives. The AASM membership includes more than 9,500 physicians, scientists, and other health care professionals who help people who have sleep disorders. The AASM also accredits 2,300 sleep centers that are providing the highest quality of sleep care across the country.
November 3rd, 2025| Featured, Press Releases
longtrailer
7月前
EXECUTIVE INTERVIEW - Incannex Healthcare: Pioneering the Future of Cannabinoid and Psychedelic Therapies.
https://drug-dev.com/expert-content/executive-interview-incannex-healthcare-pioneering-the-future-of-cannabinoid-and-psychedelic-therapies/
As global interest in psychedelic and cannabinoid-based therapies accelerates, one company stands at the intersection of scientific innovation and regulatory advancement: Incannex Healthcare Inc. (NASDAQ: IXHL). Led by CEO Joel Latham, Incannex is developing a diverse pipeline of treatments targeting some of the most challenging and underserved indications in medicine, including Obstructive Sleep Apnea, Rheumatoid Arthritis, and Generalized Anxiety Disorder. What sets Incannex apart is its commitment to rigorous clinical validation, international regulatory engagement, and a vision for multimodal drug delivery that blends emerging science with patient-focused outcomes.
In this exclusive interview, Joel Latham shares how the company navigates complex global regulatory pathways, building strategic collaborations, and forging a path toward commercial success that balances both scientific rigor and therapeutic optimism.
Q: Can you provide a high-level overview of your company’s mission and what makes you stand out in the drug development landscape?
A: At Incannex Healthcare, our mission is to develop and commercialize innovative therapies that address persistent and underserved medical conditions. We focus on diseases where current treatments are inadequate or come with significant drawbacks, and we approach them with a science-driven, clinically rigorous strategy.
What makes us stand out is our dual focus on cannabinoid-based pharmaceuticals and psychedelic-assisted therapies. Unlike many companies in this emerging space, we’re committed to advancing our therapies through FDA and TGA-regulated clinical trials, ensuring that our treatments are not just promising, but provably effective and approvable.
We also prioritize fixed-dose combination therapies, which allow us to target complex conditions through multiple mechanisms, improve outcomes, and develop strong intellectual property. For instance, our IHL-42X program combines dronabinol and acetazolamide to treat Obstructive Sleep Apnea (OSA), an approach we believe could reshape the current standard of care.
With a seasoned team and strategic partnerships in place, we’re efficiently moving assets through the pipeline. At the end of the day, our goal is to bring forward prescription therapies that are novel, effective, and capable of making a real difference in patients’ lives.
Q: Let’s talk about IHL-42X, your lead candidate for OSA. Why is this such a compelling target, and what have you seen in clinical trials so far?
A: OSA is a massive public health issue, with it estimating to impact over a billion people globally. It disrupts sleep, increases the risk of cardiovascular disease, and significantly impacts quality of life. Yet, there are no FDA-approved pharmacological treatments. The standard of care, CPAP devices, suffer from notoriously poor compliance, and that is the gap we aim to fill with IHL-42X.
IHL-42X is a fixed-dose oral combination of acetazolamide and dronabinol, designed to reduce the Apnea-Hypopnea Index (AHI), the gold-standard measurement of OSA severity. In our Phase 2 trial, we saw significant improvements, particularly with the lowest dose, which reduced AHI by 51% on average. Importantly, 25% of participants experienced reductions of over 80%. That’s a huge signal. We’re now conducting a global Phase 2/3 trial, called RePOSA, involving patients who are either non-compliant with, or intolerant to, CPAP. We’re optimistic that IHL-42X could become the first approved pharmacotherapy for OSA.
Q: Another exciting area is your work in Rheumatoid Arthritis (RA). What is the science behind IHL-675A, and how does it differ from other anti-inflammatory drugs on the market?
A: RA is a complex autoimmune condition where inflammation plays a central role. Current treatments often don’t work for everyone and can come with significant side effects. IHL-675A is our investigational therapy that combines two active agents: hydroxychloroquine (HCQ), a long-established immune modulator, and synthetic cannabidiol (CBD), which is known to exert anti-inflammatory effects through the endocannabinoid system.
What makes this exciting is the synergistic mechanism, HCQ dampens overactive immune responses, while CBD inhibits pro-inflammatory cytokines and prostaglandins. Together, they target both immune and inflammatory pathways. Preclinical models showed substantial reductions in inflammation, and our Phase 1 data confirmed a favorable safety profile and bioequivalence. Now, we’re advancing IHL-675A into Phase 2 trials to evaluate its efficacy in RA patients. If successful, it could offer a new oral, non-opioid alternative for patients struggling with disease-modifying antirheumatic drugs.
Q: You’re also exploring psychedelic-assisted therapy for Generalized Anxiety Disorder (GAD) with PSX-001. What’s your perspective on the future of psychedelics in mental health care?
A: There’s growing recognition that traditional psychiatric drugs, especially SSRIs and benzodiazepines, aren’t working for everyone. Psychedelics like psilocybin have shown promise in helping patients “reframe” deeply rooted patterns of thought and behavior, particularly when paired with professional psychological support.
Our candidate, PSX-001, is a synthetic, oral psilocybin formulation that’s being studied in combination with psychotherapy. In our Phase 2 trial, 44% of participants experienced a clinically meaningful reduction in anxiety, at least a 50% drop in anxiety scores. That’s significant for a patient population often left behind by conventional treatments. The therapy was also well-tolerated with no serious adverse events.
What sets Incannex apart is that we’re not just conducting clinical research, we’re focused on pharmaceutical-grade manufacturing, controlled dosing, and regulatory pathways. We believe PSX-001 can become part of a validated, scalable model for psychedelic mental health treatment.
Q: Cannabinoids and psychedelics are emerging fields, but also heavily regulated. How does Incannex approach clinical development and regulatory strategy to meet FDA and international standards?
A: We’re not in the wellness or dispensary business, Incannex operates strictly as a pharmaceutical company. That means adhering to Good Manufacturing Practices (GMP), submitting Investigational New Drug (IND) applications, and conducting randomized, placebo-controlled trials.
We work closely with regulators in the U.S., Australia, and Europe to ensure our studies are designed for eventual marketing approval. Our team includes experienced regulatory professionals and advisors who’ve brought drugs to market globally. We also benefit from being based in Australia, where we can run trials more efficiently and access the FDA via Project Orbis and other international collaboration pathways.
Ultimately, our goal is to be among the first to bring cannabinoid and psychedelic drugs through traditional regulatory pipelines, with the same rigor as any small molecule or biologic.
Q: From a business perspective, how is Incannex positioning itself for long-term success? Are you exploring partnerships, licensing, or vertical integration?
A: We’re building a business with global scalability, and we recognize that partnerships will be an important part of that equation. Our priority today is to demonstrate strong clinical results and de-risk our pipeline, particularly as we approach pivotal trials and eventual New Drug Applications (NDAs). That gives us leverage for potential collaborations.
At the same time, we’ve invested in IP protection, proprietary formulations, and efficient trial execution, all of which make us attractive to larger pharmaceutical players. We’re certainly open to strategic partnerships or licensing agreements, especially as we complete later-stage trials. That said, our current focus remains on advancing our programs and generating high-quality clinical data.
We’re also exploring complementary technologies and delivery systems that could enhance patient outcomes or expand our pipeline in the future. The long-term goal is to be a category-defining leader in psychedelic and cannabinoid drug development, much like how biotech pioneers established the first wave of immunotherapies or gene therapies.
Q: How do patient perspectives shape your clinical programs, and how are you ensuring that your therapies align with their real needs?
At Incannex, patient needs are the north star guiding our development strategy. We deliberately focus on conditions where current therapies are inadequate, inaccessible, or non-existent, such as OSA, RA, and GAD, because these are the areas where patients are underserved and often overlooked by larger pharmaceutical companies.
From the earliest stages of program design, we listen to patients and clinicians to understand where current options fall short. For example, with OSA, poor adherence to CPAP machines has continued to be documented, yet the pharmaceutical industry has largely ignored it. That’s why we’re advancing IHL-42X as a potential first-in-class oral therapy, an option that better aligns with how patients want to manage their condition.
We also design our clinical trials with patient experience in mind. That means minimizing treatment burden, ensuring our protocols are tolerable, and building in meaningful endpoints, such as real-world functionality and symptom relief, not just biomarker data. In our psilocybin-assisted therapy program for GAD, the inclusion of psychological support isn’t just a regulatory requirement; it’s an essential part of helping participants feel seen, safe, and empowered.
Ultimately, we don’t just want to meet regulatory endpoints, we want to transform lives. That’s the lens through which we evaluate every program we advance.
Q: Looking ahead, what milestones should stakeholders watch for in the next 12–18 months?
A: The next year is expected to be big one for Incannex. We anticipate interim data from the ongoing global Phase 2/3 RePOSA trial for IHL-42X in OSA. In parallel, we are initiating the Phase 2 trial for IHL-675A in RA, which will help validate our unique combination therapy model. We also expect to report key clinical results from the Phase 2 trial of PSX-001 for GAD in the near future, another major catalyst for us.
On the corporate side, we’ll continue to engage with regulators and explore global licensing and commercialization strategies. If all progresses as planned, we will be well-positioned for late-stage development, strategic partnering, or even submission for marketing approval in some regions.
Overall it really is an exciting time; we believe we’re at the forefront of a shift in chronic disease treatment, and we look forward to sharing our journey with the broader scientific and investment communities.
Conclusion
As Incannex Healthcare continues to advance a robust pipeline of cannabinoid and psychedelic therapies, it is staking out a unique and disciplined path in an industry full of promise, and pitfalls. Joel Latham’s insights reflect not only the company’s scientific ambition but its commitment to regulatory rigor and patient impact. With multiple data readouts on the horizon, Incannex is a company to watch closely as the future of mental health and chronic disease treatment continues to evolve.
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