Nexalis Doses First Patient in Phase 1 Trial of Inhaled Panic Disorder Therapy
Nexalis Therapeutics doses first patient in Phase 1 trial of inhaled panic disorder therapy
Nexalis Therapeutics (ASX: NX1) has dosed the first patient in its Phase 1 clinical trial of IRX-616a, marking the transition from preclinical development to human clinical testing of the company’s inhaled therapy for Panic Disorder. The first-in-human study is being conducted at CMAX in Adelaide, a specialist early-phase clinical research unit.
The Nexalis Therapeutics IRX-616a Phase 1 trial is designed as a randomised, double-blind, placebo-controlled, single ascending dose study. Key characteristics of the trial design include:
- Randomised: Participants are allocated to treatment or placebo groups using a randomisation protocol
- Double-blind: Neither participants nor study staff know which treatment is being administered
- Placebo-controlled: Active treatment is compared against an inactive placebo to isolate therapeutic effects
Up to 24 healthy participants will be enrolled across three dose cohorts. IRX-616a is delivered via a pressurised metered-dose inhaler providing 2.5 mg of Cannabidiol (CBD) per actuation. The trial remains on track to dose the final participant before the end of June 2026.
Clinical trial commencement de-risks the development pathway and validates the company’s ability to execute on its pipeline strategy. Moving from preclinical research into human studies represents a material milestone that investors typically view as reducing technical risk.
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Why inhaled delivery matters for panic disorder treatment
Panic Disorder is a debilitating anxiety condition characterised by recurrent unexpected panic attacks and persistent concern about future episodes. Patients often experience significant functional impairment as they navigate daily life with the fear of when the next attack might occur.
The delivery method for acute conditions like Panic Disorder matters significantly. Oral medications must pass through the digestive system and liver before reaching systemic circulation, which delays therapeutic onset. For someone experiencing an acute panic attack, waiting 30-60 minutes for an oral medication to take effect may not provide adequate relief when it is needed most.
Inhalation is intended to deliver rapid systemic absorption while bypassing first-pass hepatic metabolism (the process where the liver breaks down a portion of the drug before it reaches circulation). This supports a fast onset profile that aligns with the acute nature of panic episodes, potentially providing relief within minutes rather than hours.
This differentiated delivery mechanism may provide a competitive advantage over existing oral treatments that have slower onset profiles. If clinical data supports rapid relief, IRX-616a could address a meaningful gap in current treatment options.
CEO Darryl Davies
“Commencing dosing in our Phase 1 IRX-616a study is a major milestone. We look forward to the upcoming SRC assessment as we continue to advance IRX-616a toward addressing the unmet need in acute panic and anxiety-related conditions.”
Trial structure and safety oversight
The Phase 1 study follows a methodical approach to evaluate safety across three sequential dose cohorts. Each cohort includes sentinel dosing, where an initial participant receives treatment and is monitored before additional participants are enrolled. This is followed by staggered enrolment, with progression to subsequent dose levels subject to review of safety data.
Dose escalation is overseen by an independent Safety Review Committee (SRC), which evaluates emerging safety data before approving progression to higher doses. This independent oversight provides an additional layer of patient protection and ensures that any safety signals are identified and addressed before dose escalation proceeds.
An SRC meeting is scheduled for early April 2026 to review emerging safety data and assess the suitability of dose escalation for the second cohort. The trial timeline anticipates dosing completion before the end of June 2026.
| Milestone | Timing | Status |
|---|---|---|
| First patient dosed | March 2026 | Complete |
| SRC meeting (Cohort 2 assessment) | Early April 2026 | Upcoming |
| Final participant dosing | Before end June 2026 | On track |
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Development pathway and funding position
Following completion of the Phase 1 trial, Nexalis Therapeutics plans to initiate a Phase 2 study in the target patient population. The company is pursuing U.S. FDA approval via the 505(b)(2) regulatory pathway, which leverages existing data on known active ingredients to potentially accelerate approval timelines and reduce development costs compared to traditional new drug applications.
The company has secured a funding partner with a facility of up to $52.3 million to accelerate pipeline development. This funded development pathway reduces near-term capital raising risk, a material consideration for investors evaluating clinical-stage biotechnology companies where cash runway is often a constraining factor.
Beyond IRX-616a, Nexalis Therapeutics is advancing a broader pipeline of rapid onset therapies:
- IRX-211 for Breakthrough Cancer Pain
- IRX-616a for Panic Disorder
- SRX-25 for Treatment-Resistant Depression
Each programme targets conditions where current treatment options carry dependency concerns or have suboptimal efficacy profiles. The 505(b)(2) pathway offers a potentially faster and more cost-effective route to approval than traditional new drug applications, particularly for formulations or delivery methods of known active pharmaceutical ingredients.
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