InhaleRx advances clinical trials of CBD drugs for treatment of acute pain and panic disorder

Australian healthcare company InhaleRx (ASX: IRX) has advanced the activation of a Phase 1 trial of cannabinoid (CBD)-derived inhaled drug IRX211 for the treatment of acute pain and the preparation of ethics application for a Phase 2 trial of CBD formulation IRX616a for panic disorder.

The Phase 1 trial is considered a critical cornerstone for all potential future pain indications being evaluated by the company including complex regional pain syndrome.

Ethics approval for the trial was granted in March while the “First Patient First Dose” milestone was achieved in June.

The first cohort of participants were dosed in early June and the company anticipates closing the second cohort during the current quarter.

Phase 2 ethics

Ingenu CRO Pty Ltd (a subsidiary of InhaleRx shareholder Cannvalate Pty Ltd) was appointed to co-ordinate progress of the Phase 1 trial and is in the final stages of being able to submit to ethics for the Phase 2 IRX616a clinical program.

A clinical trial notification has already been assigned and screening is due to commence for Phase 2 subject to further capital raising.

Ongoing work

Ongoing regulatory work is being conducted in anticipation of submitting an investigational new drug (IND) application for IRX616a.

InhaleRx said additional chemistry, manufacturing and controls work was needed as well as final checks prior to lodgement, currently targeted for end September.

Trial manufacturing

Trial batch contract manufacturing has been completed for IRX211 Phase 1 and the company said manufacturing for the Phase 2 trial will be carried out before year end.

All components have been sourced and are with the trial batch manufacturer in anticipation of this work.

InhaleRx’s overarching goal remains to achieve a new drug application (NDA) with the US Food and Drug Administration.

Financials

InhaleRx reported an operational spend of approximately $980,000 for the June quarter.

This was comprised of $770,000 in research and development costs (including drug formulation, regulatory engagement and trial manufacturing); $39,000 in director fees; $37,000 in salaries paid to employees; $110,000 in general corporate costs (including leadership team salaries and company insurance); and $18,000 in audit-related costs.

The company reported a net tax refund of $55,000 related to GST costs.