Progress in the use of cannabinoid pharmaceuticals has been extensive. Cannabinoids interact with the endocannabinoid system in the body, which plays a role in regulating various functions like mood, pain, and appetite.
To gain an insight into developments, Digital Journal spoke with Joel Latham, CEO of Incannex Healthcare Inc. Incannex is a leading clinical-stage biopharmaceutical company developing novel cannabinoid pharmaceuticals and psychedelic therapies to treat chronic conditions including obstructive sleep apnea, rheumatoid arthritis, and generalized anxiety disorder.
Digital Journal: Can you provide a brief background on Incannex Healthcare?
Joel Latham: Incannex Healthcare Inc. is a clinical-stage biopharmaceutical company specializing in the development of innovative therapies that combine cannabinoids and psychedelics to address chronic conditions with limited or no effective treatments. Founded in Australia, the company re-domiciled to the U.S. in November 2023 and is now headquartered in New York City. Our shares are publicly traded on the Nasdaq under the ticker symbol IXHL.
Incannex employs a strategy of developing combination therapies that leverage the synergistic effects of cannabinoids or psychedelics with other pharmaceutical agents. This approach aims to enhance therapeutic efficacy while minimizing side effects. Our pipeline addresses conditions with significant unmet medical needs, including obstructive sleep apnea (OSA), rheumatoid arthritis, and generalized anxiety disorder (GAD).
We currently have three key therapeutic programs:
- IHL-42X: An oral fixed-dose combination of dronabinol (a synthetic cannabinoid) and acetazolamide, designed to synergistically treat OSA. Following promising Phase 2 results, the Phase 3 component of the RePOSA clinical trial is underway in the U.S. This study aims to evaluate the efficacy and safety of IHL-42X, which has the potential to become the first FDA-approved oral therapy for OSA.
- IHL-675A: A combination of cannabidiol (CBD) and hydroxychloroquine, targeting inflammatory conditions such as rheumatoid arthritis, inflammatory bowel disease, and lung inflammation. This candidate is currently in Phase 2 clinical trials.
- PSX-001: A synthetic psilocybin therapy administered with psychotherapy for the treatment of GAD. This program is in Phase 2b clinical development.
DJ: What are the benefits of leveraging cannabinoids in the development of new medications?
Latham: For Incannex, leveraging cannabinoids provides strategic advantages that align with its focus on innovative combination therapies. The benefits are:
- Differentiated Products: By combining cannabinoids with existing drugs (e.g. IHL-42X, IHL-675A), Incannex creates novel, patentable treatments with enhanced efficacy and lower side effects.
- Targeting Unmet Needs: Incannex applies this approach to conditions like obstructive sleep apnoea, anxiety, and inflammation—markets with few or no approved drug options.
- Favourable Safety Profile: Cannabinoids such as CBD and dronabinol are generally well-tolerated, making them ideal for chronic conditions.
- Regulatory Tailwinds: With growing global acceptance and ongoing late-stage trials, Incannex is well-positioned for commercial and regulatory success.
- Scalable R&D Model: The platform enables development of additional therapies across multiple indications using a similar combination strategy.
DJ: What do you say to people who are hesitant about their use in drug development?
Latham: To those hesitant about the use of cannabinoids in drug development, we say cannabinoids are often misunderstood due to their association with recreational use, but in a pharmaceutical setting, they are rigorously studied, purified, and precisely dosed—just like any other active ingredient. At Incannex, we’re not using raw cannabis or promoting alternative medicine. We develop regulated, clinically tested combination therapies with clear mechanisms of action.
Our approach uses synthetic or pharmaceutical-grade cannabinoids combined with proven drugs to create therapies with improved safety and efficacy profiles. We focus on serious medical conditions with limited treatment options, such as obstructive sleep apnoea, anxiety, and inflammatory diseases.
There is a growing body of clinical data and regulatory support for cannabinoid-based medicines. When used scientifically, they offer a legitimate and promising path to better treatments.
Scepticism is understandable—but it’s important that science, not stigma, drives the conversation.
DJ: What chronic diseases are you currently focused on? Can you discuss your pipeline in those areas?
Latham: Incannex is focused on developing therapies for chronic diseases with limited or no effective treatment options. Our pipeline targets high-need areas where innovative combination therapies using cannabinoids or psychedelics can make a meaningful impact.
We are advancing IHL-42X for obstructive sleep apnoea (OSA), a fixed-dose combination of dronabinol (a synthetic cannabinoid) and acetazolamide. The treatment is designed to reduce apnoea events and improve sleep quality and is currently progressing through Phase 3 trials in the U.S. and UK. If successful, IHL-42X could become the first approved drug therapy for OSA.
We are also developing IHL-675A, a combination of CBD and hydroxychloroquine for the treatment of inflammatory conditions such as rheumatoid arthritis, inflammatory bowel disease, and lung inflammation. This program is currently in Phase 2 trials, following strong preclinical data that demonstrated improved efficacy compared to standard treatments.
In the mental health space, we are developing PSX-001, a synthetic psilocybin-assisted psychotherapy program for individuals with generalised anxiety disorder (GAD). The program is in a Phase 2b clinical trial in Australia, with potential for international expansion.
Each of these programs reflects our strategy of using cannabinoid and psychedelic agents in combination therapies to target chronic conditions with high unmet need.
DJ: How do you ensure drug purity and efficacy?
Latham: At Incannex, ensuring drug purity and efficacy is central to our development process. We work with Good Manufacturing Practice (GMP)-certified facilities to manufacture all drug products under tightly controlled conditions, ensuring consistent quality, purity, and safety across batches.
Each formulation undergoes extensive analytical testing, including stability, potency, and contaminant screening, to meet global pharmaceutical standards. This applies to both the cannabinoid or psychedelic components and the accompanying pharmaceutical agents.
We validate efficacy and safety through rigorous preclinical and clinical trials, conducted under FDA and international regulatory guidelines. Independent monitoring is used to ensure data accuracy and trial integrity.
Our dedicated quality assurance and regulatory teams oversee compliance throughout the full drug development lifecycle—from research to commercial readiness.
We apply the same scientific and regulatory standards to our therapies as any traditional pharmaceutical company, ensuring our products are safe, effective, and high quality.
DJ: Do you use real-time release technology?
Latham: At this stage, Incannex does not utilise real-time release (RTR) technology in its manufacturing processes. Our current development programs rely on conventional quality control methods, including batch release testing, to ensure the safety, purity, and efficacy of our drug products.
That said, as our clinical programs advance and we move closer to commercial-scale manufacturing, we continue to evaluate new technologies—including RTR—where they may add value. RTR could potentially improve manufacturing efficiency and responsiveness in the future, particularly for products with high-volume or time-sensitive demands.
Our focus remains on maintaining the highest quality standards using proven, compliant methods, while remaining open to innovation as our pipeline matures.
DJ: Where do you expect the cannabinoid pharmaceutical industry to go in the next five years?
Latham: Over the next five years, the cannabinoid pharmaceutical industry is expected to evolve significantly, moving from niche applications toward broader mainstream adoption. Several key trends are likely to shape the future:
Regulatory advancement
Governments and regulatory agencies, including the FDA and the European Medicines Agency (EMA), are increasingly recognising cannabinoids as legitimate therapeutic agents. As more clinical data emerges, we expect to see greater regulatory clarity and more approvals of cannabinoid-based drugs for specific, well-defined indications.
Shift toward standardised, pharmaceutical-grade products
The focus will continue to move away from unregulated or wellness-oriented products toward rigorously tested, GMP-manufactured pharmaceuticals. Companies like Incannex, developing fixed-dose combination therapies, are well-positioned in this environment.
Growth in high-value therapeutic areas
Expect to see increased cannabinoid applications in areas such as pain management, neurological disorders, sleep disorders, anxiety, and inflammation—particularly where conventional treatments are inadequate or poorly tolerated.
More strategic partnerships and M&A activity
As big pharma takes a closer look at the space, we anticipate an increase in licensing deals, co-development partnerships, and acquisitions, especially targeting companies with late-stage assets or novel IP.
Enhanced public and clinical acceptance
As stigma continues to decline and medical evidence grows, prescriber confidence and patient demand for cannabinoid-based medicines will rise, particularly in chronic disease management.
In short, the industry is transitioning from early-stage exploration to scientifically validated, regulatory-backed development—creating significant opportunities for leaders in clinical cannabinoid innovation like Incannex.
