Australian healthcare company InhaleRx (ASX: IRX) has confirmed detailed plans and risk mitigation strategies for ethics committee submissions are in place prior to patient recruitment for clinical trials of its lead drugs IRX616a and IRX211.
The drugs will be used to address unmet medical needs in mental health and pain management with the primary goal of achieving approvals with the US Food and Drug Administration (FDA).
Specifically, IRX616a has been designed to treat panic disorder while IRX211 will treat complex regional pain syndrome.
In its December quarterly report, InhaleRx said it assembled a team of experts to further refine designs and conduct regulatory preparations prior to commencement of the trials in 2024.
An Australia-based contract manufacturing partner has been engaged across both programs to produce a trial batch of pressurised metered dose inhalers (pMDIs) for the drugs.
Contract research organisation
In December, InhaleRx announced it would appoint Ingenu CRO as the lead contract research organisation for its planned clinical trials for a cash consideration of $5 million.
Ingenu is considered a related party as InhaleRx chief executive officer Darryl Davies is also on the Ingenu management team and InhaleRx medical adviser Dr Sud Agrawal is on the Ingenu board.
Ingenu is also a subsidiary company of InhaleRx shareholder Cannvalate.
The corporate connections mean the official appointment of Ingenu will be subject to shareholder approval.
Medihale development
InhaleRx continues to develop its Medihale vape device and has been working with various heat inhalation systems to better understand the advantages and shortfalls of existing products on the market.
The company commenced distributing C-cell vapes during the six months to December 2022.
While not a dose-controlled device, the C-cell inhalation product has provided InhaleRx with market insights and feedback from patients who have used cannabinoids delivered via these devices to assist with managing their symptoms across a range of different indications.
InhaleRx’s cash reserves at year end totalled $2.13 million.
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