Australian healthcare company InhaleRx (ASX: IRX) has completed the second of four cohorts in a Phase 1 clinical trial investigating the safety and pharmacokinetics of lead cannabinoid drug delivery system IRX211.
The company has now recruited and dosed 16 participants across the first and second cohorts of the trial, which is focused on potential treatments for acute pain and panic disorder.
Critical data from the two cohorts is believed to closely correlate with IRX211’s performance which has exceeded expectations in terms of safety and the pharmacokinetic profile.
No serious adverse events have been reported.
Data generated to date has provided InhaleRx’s board with the confidence to move on to the third cohort, which is expected to commence screening for participants next month.
Chief executive officer Darryl Davies said the results from the second cohort represented a “significant milestone”.
“This is the halfway mark for our Phase 1 trial with two of the four cohorts now complete,” he said.
“The safety, tolerability and pharmacokinetic profile characteristics of IRX211 are looking really promising and we are delighted by the data insights we have received so far.”
Mr Davies said the company was looking forward to data generated from a subsequent dose escalation of IRX211 in the third cohort.
Drug delivery system
IRX211 is a cannabinoid drug (pure dronabinol) delivery system based on a pressurised metered dose inhaler.
It has been optimised to rapidly deliver a fixed dose via inhalation and address the symptoms of breakthrough or acute pain.
InhaleRx is conducting a double-blind, randomised, placebo-controlled, single ascending dose study of IRX211, involving four cohorts of eight participants each.
Each cohort will receive either a pre-determined dose of IRX211, or a matching placebo.
The trial is designed to assess the pharmacokinetics, safety and tolerability of single escalating doses of the drug in healthy male and female subjects.
Phase 2 trial
Mr Davies said the results would be critical to guiding a Phase 2 trial and subsequent pivotal trials of IRX211.
They would also contribute to the company’s regulatory strategy targeting a new drug approval submission to the US Food and Drug Administration.