Nexalis Therapeutics (ASX:NX1) has commenced dosing in its Phase 1 clinical trial of IRX-616a, a novel treatment candidate for panic disorder.
The study, conducted at the CMAX clinical research unit in Adelaide, marks a significant milestone in developing rapid-onset therapies for acute anxiety.
IRX-616a is a drug-device inhalation aerosol that delivers 2.5 mg of cannabidiol per actuation via a pressurised metered-dose inhaler.
By using the inhalation route, the treatment aims for rapid systemic absorption and avoids first-pass hepatic metabolism, potentially providing faster relief for those experiencing acute panic symptoms.
The Phase 1 trial (Protocol IRX616-003) is a first-in-human, randomised, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of IRX-616a in up to 24 healthy adult volunteers.
Participants are organised into three sequential dose cohorts, with an independent Safety Review Committee overseeing the dose escalation process.
The first patient has already been dosed, and a formal SRC meeting is scheduled for early April to review preliminary safety data before escalating to the second cohort.
Nexalis CEO Darryl Davies emphasised that this trial is a critical step toward addressing the unmet needs of individuals living with the debilitating effects of PD.
The company remains on track to complete dosing for the final participant by the end of June 2026.
Nexalis plans to initiate Phase 2 trials within the target patient population to further evaluate clinical efficacy.