• Phase 1 trial commenced with first eligible participant screened and recruited
• Randomised, double-blind, placebo-controlled single ascending dose trial in up to 24 healthy volunteers
• Differentiated delivery platform with inhaled CBD designed for rapid systemic absorption and fast onset

Nexalis Therapeutics Ltd (NX1) has announced that the first eligible participant has been screened and recruited in its Phase 1 clinical trial of IRX-616a as a treatment for Panic Disorder. The Phase 1 study (Protocol IRX616-003) is a first-in-human, randomised, double-blind, placebo-controlled, single ascending dose trial designed to evaluate the pharmacokinetics (PK), safety and tolerability of IRX-616a in healthy adult volunteers. IRX-616a is a carefully designed drug device inhalation aerosol delivered via a pressurised metered-dose inhaler, providing 2.5 mg of Cannabidiol (CBD) per actuation. The inhalation route is intended to deliver rapid systemic absorption while bypassing first-pass hepatic metabolism, supporting a fast onset profile for acute indications. The study is being conducted at CMAX, Adelaide, a specialist early-phase clinical research unit. Up to 24 healthy participants will be enrolled across three sequential dose cohorts, with dose escalation overseen by an independent Safety Review Committee. The primary objective of the study is to characterise plasma PK profiles of CBD and its major metabolites following single inhaled doses under fasted conditions. Secondary objectives include evaluation of safety and tolerability, including adverse events, laboratory parameters, vital signs, ECG assessments and C-SSRS monitoring. The Phase 1 trial is expecting to have dosed the last participant before the end of June 2026, at which stage, the Company is planning on commencing the Phase 2 trial in the patient population.

Nexalis Therapeutics is developing rapid onset therapies to address unmet medical needs in pain management and mental health sectors. The company has secured a funding partner with a facility of up to $52.3m to accelerate the development of IRX-211 to treat Breakthrough Cancer Pain (BTcP), IRX-616a to treat Panic Disorder (PD) and SRX-25 for the treatment of Treatment-Resistant Depression (TRD). The overarching goal is to pursue U.S. FDA approval and registration using rapid and cost-effective regulatory pathways, such as 505(b)(2).