Nexalis Therapeutics Ltd (ASX: NX1), an Australian clinical stage drug development company focused on rapid onset therapies for pain management and mental health, has announced the commencement of its Phase 1 clinical trial for IRX-616a, a potential treatment for panic disorder. The first eligible participant has been screened and recruited for the study, marking a significant milestone for the company. 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 Phase 1 trial (Protocol IRX616-003) is a randomised, double-blind, placebo-controlled, single ascending dose study. It aims to evaluate the pharmacokinetics (PK), safety, and tolerability of IRX-616a in up to 24 healthy adult volunteers. IRX-616a is an inhaled drug-device combination delivering 2.5mg of cannabidiol (CBD) per actuation. The inhaled delivery method is designed to provide rapid systemic absorption, bypassing first-pass hepatic metabolism and facilitating a fast onset profile.
The study is being conducted at CMAX, Adelaide, with oversight from an independent Safety Review Committee. The primary objective is to characterise the plasma PK profiles of CBD and its major metabolites. Secondary objectives include assessing safety and tolerability through monitoring adverse events, laboratory parameters, vital signs, ECG assessments, and C-SSRS monitoring. The trial expects to dose 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.
According to Nexalis Therapeutics, there are currently no FDA-approved drugs for treating Panic Disorder via inhalation. The company anticipates further updates from the trial as key milestones are achieved.
