Nexalis Therapeutics completes Phase 1 Inhaled CBD trial

Nexalis Therapeutics (ASX:NX1) announced a clinical milestone following the final dosing of its Phase 1 study for IRX-616a, a novel inhaled cannabidiol formulation.

The first-in-human trial, conducted at CMAX Adelaide, utilised a randomised, double-blind, placebo-controlled framework to assess the safety and pharmacokinetics of the drug across three healthy volunteer cohorts.

The company reported an absence of serious adverse events throughout the study, bolstering confidence in the safety profile of this rapid-onset therapeutic platform.

Nexalis CEO Darryl Davies emphasised that the completion of this dosing phase is a "significant achievement" as the company seeks to address a critical unmet need for fast-acting treatments for acute panic and anxiety-related conditions.

Bo FDA-approved inhaled medications exist specifically for panic disorder, positioning IRX-616a as a potentially disruptive solution in the mental health sector.

With the dosing phase concluded, the company is now transitioning into database lock and final statistical analysis.

Nexalis has already formalised preparations for Phase 2 clinical development, which will focus on target patient populations to further evaluate the efficacy of the inhaled CBD delivery method.

Investors and medical professionals are now awaiting the release of topline Phase 1 results, as the company moves to finalise regulatory preparations for the next stage of its clinical pipeline.

At the time of reporting, Nexalis Therapeutics’ share price was $0.022.