InhaleRx (ASX: IRX) has lodged its quarterly report for the three months to end September, citing $180,000 expenditure on drug development and regulatory advice costs in preparation for clinical trials into inhaled cannabinoids for the treatment of complex regional pain syndrome and panic disorder.
The company’s core focus during the period was on refining a regulatory pathway with the US Food and Drug Administration relating to drug development, as well as setting up manufacturing partnerships for the sourcing of drug-device combinations.
It is aiming to achieve new drug approval (NDA) with the FDA in the shortest time frame possible.
InhaleRx has been working with a UK-based drug formulation specialist on the development of medications to be dispensed via pressurised metered dose inhalers (pMDI).
It reported that formulation work had delivered “very promising” three-month stability data.
Contract manufacturing partner
During the quarter, an Australian-based contract manufacturing partner was selected to produce pMDI combination products for the panic disorder trial, with a contract expected to be formalised in the coming weeks.
InhaleRx also commenced a tender process to select a local or international contract research organisation (CRO) for the planned clinical trials.
The process has been managed by a tender selection committee comprised of InhaleRx independent non-executive directors and a UK-based specialist CRO consultant.
It is expected that the tender will be awarded by end-November.
Medihale progress
InhaleRx continued to develop its Medihale vape device during the quarter and has been working with various heat (not burn) inhalation device systems to better understand the advantages and shortfalls of existing products on the market.
The company’s ‘white label’ offering continues to gather momentum with interest across the Australian and New Zealand markets.
During the quarter, InhaleRx made a decision to stop sales of the Voom device and wrote off its remaining stock as it had identified tried and tested products which could be more efficient at delivering cannabinoid medications.
The company expects to provide further information on the new products it plans to distribute to the market in the December quarter.
