Nexalis Clears First Safety Hurdle in Trial of Inhaled Panic Disorder Treatment

Nexalis Therapeutics advances IRX-616a into second dosing cohort

Nexalis Therapeutics (ASX: NX1) has completed dosing of the first cohort in its Phase 1 trial of IRX-616a, an inhaled cannabidiol (CBD) formulation targeting acute panic and anxiety episodes. The Safety Review Committee (SRC) has approved progression to Cohort 2, with dosing now underway at CMAX Adelaide.

The milestone confirms the trial is progressing as planned, with no safety or tolerability concerns flagged following review of data from 8 subjects in Cohort 1. The randomised, double-blind, placebo-controlled study will enrol up to 24 healthy volunteers in total, with completion of last participant dosing expected before the end of June 2026.

CEO Darryl Davies

“We are very pleased with the outcome of the Safety Review Committee assessment, which confirms that the study is progressing as expected. Advancing into Cohort 2 is an important step in the clinical development of IRX-616a and continues to build confidence in our rapid-onset inhaled delivery platform.”

SRC approval to escalate dosing represents an important de-risking milestone at this early stage of clinical development. The absence of safety red flags supports continued dose escalation and reinforces confidence in the product’s tolerability profile ahead of patient trials.

What is IRX-616a and how does it work?

IRX-616a is an inhaled cannabidiol formulation developed to address a critical gap in the treatment of acute panic and anxiety-related conditions. The therapy is designed to overcome a key limitation of existing treatments: delayed onset of action when rapid relief is needed most.

The product is delivered via a pressurised metered-dose inhaler designed to enable rapid systemic absorption. This delivery mechanism aims to provide faster therapeutic effect compared to oral medications.

Key features of IRX-616a include:

1. What it is: An inhaled cannabidiol (CBD) formulation targeting acute panic and anxiety episodes
2. How it is delivered: Pressurised metered-dose inhaler designed for rapid systemic absorption
3. Why speed matters: Acute panic episodes require rapid relief; existing therapies often have delayed onset of action

Rapid onset differentiates IRX-616a from current treatment options, potentially positioning it as a preferred rescue therapy for patients experiencing acute episodes. If clinical development succeeds, the product could establish a distinct therapeutic niche in the panic disorder treatment landscape.

The market opportunity in panic and anxiety disorders

Panic disorder is a debilitating anxiety condition characterised by recurrent, unexpected panic attacks and persistent concern about future episodes, often leading to significant functional impairment. Patients frequently experience physical symptoms including rapid heartbeat, shortness of breath, and chest pain, which can severely impact quality of life and daily functioning.

The commercial opportunity is substantial. The Total Addressable Market for anxiety disorders and depression treatments is projected to reach US$13.3 billion by 2027, reflecting growing prevalence and unmet treatment needs across multiple patient populations.

The large addressable market supports commercial potential if clinical development succeeds, particularly given the product’s differentiated rapid-onset profile compared to conventional oral therapies.

Phase 1 timeline and next steps

The Phase 1 study is designed to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers before advancing to patient populations. Following completion of Cohort 2 dosing, the trial will progress through remaining cohorts with the last participant expected to complete dosing before the end of June 2026.

Upon successful completion of Phase 1, Nexalis Therapeutics plans to commence Phase 2 trials in patients with panic disorder. This transition represents a critical inflection point, moving from healthy volunteer safety testing to efficacy assessment in the target patient population.

Upcoming milestones include:

• Phase 1 last participant dosed: Before end June 2026
• Phase 2 commencement: Following Phase 1 completion
• Phase 2 population: Patients with panic disorder

Clear near-term catalysts with Phase 1 readout and Phase 2 initiation both expected in 2026 provide defined value inflection points for investors tracking the programme’s progress.

Nexalis Therapeutics’ broader pipeline and funding position

IRX-616a forms part of Nexalis Therapeutics’ broader development strategy targeting rapid-onset therapies for pain management and mental health conditions. The company has secured a funding facility of up to $52.3 million to accelerate development across three lead assets.

The pipeline addresses distinct therapeutic areas with significant unmet needs:

• IRX-211: Breakthrough Cancer Pain
• IRX-616a: Panic Disorder (current trial)
• SRX-25: Treatment-Resistant Depression

Nexalis Therapeutics is pursuing approval via the US FDA 505(b)(2) regulatory pathway, which allows reliance on existing safety and efficacy data from previously approved products. This approach reduces development risk and cost compared to traditional New Drug Application (NDA) pathways, potentially accelerating time to market and reducing capital requirements.

The funded pipeline across multiple indications in pain and mental health sectors, combined with the capital-efficient regulatory strategy, positions the company to advance multiple programmes simultaneously. The 505(b)(2) pathway, if successfully executed, could deliver meaningful development cost savings and timeline compression compared to conventional development routes.

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