Australian healthcare company InhaleRx (ASX: IRX) has achieved significant advancements in its clinical trials involving cannabinoid (CBD)-derived drugs. The company has taken meaningful steps forward in its efforts to address acute pain and panic disorder through innovative CBD formulations. These developments underscore InhaleRx’s commitment to pioneering therapeutic solutions in the field of healthcare.
Phase 1 Trial Activation and Milestones
InhaleRx has initiated the activation of a Phase 1 trial for its CBD-derived inhaled drug, IRX211. This trial focuses on evaluating the drug’s potential efficacy in treating acute pain, with a broader scope encompassing various pain indications, including complex regional pain syndrome. The Phase 1 trial, granted ethics approval in March, reached a significant milestone with the achievement of the “First Patient First Dose” in June. Notably, the trial’s progress is integral to shaping the company’s future pain-related investigations.
Moving Towards Phase 2: Panic Disorder Treatment
Concurrently, InhaleRx is preparing to submit an ethics application for a Phase 2 trial of its CBD formulation, IRX616a, designed to address panic disorder. The company is diligently working towards the commencement of Phase 2, subject to successful capital raising. The involvement of Ingenu CRO Pty Ltd, a subsidiary of InhaleRx shareholder Cannvalate Pty Ltd, underscores the company’s strategic partnerships in steering these trials towards success.
Strategic Coordination and Regulatory Milestones
Ingenu CRO Pty Ltd has been tasked with coordinating the Phase 1 trial’s progress and is in the final stages of preparing for the Phase 2 IRX616a clinical program’s ethics submission. A clinical trial notification has already been assigned, marking a significant step forward. As InhaleRx anticipates further capital raising, the Phase 2 trial’s screening is poised to commence, demonstrating the company’s commitment to executing its clinical trial objectives.
Paving the Way for Regulatory Approvals
InhaleRx’s dedication to rigorous regulatory compliance is evident in its pursuit of an investigational new drug (IND) application for IRX616a. The company is engaged in comprehensive chemistry, manufacturing, and controls work, while also conducting final checks in preparation for the IND application submission, anticipated by the end of September. These meticulous efforts underscore InhaleRx’s commitment to achieving regulatory approvals and advancing its therapeutic pipeline.
Manufacturing Progress and Aspirations
InhaleRx has made noteworthy strides in the manufacturing realm as well. Trial batch contract manufacturing has been successfully completed for the IRX211 Phase 1 trial. Building on this accomplishment, manufacturing for the Phase 2 trial (IRX616a) is slated for completion by the end of the year. InhaleRx has ensured the seamless sourcing and availability of all necessary components for these manufacturing endeavours.
Aiming for Regulatory Approval and Financial Update
InhaleRx maintains a steadfast commitment to achieving a new drug application (NDA) with the US Food and Drug Administration (FDA). The company’s strategic approach aligns with its overarching goal of bringing innovative therapeutic solutions to patients in need.
Financial Overview
InhaleRx reported operational spending of approximately $980,000 for the June quarter. These expenditures encompass various aspects of research and development, including drug formulation, regulatory engagement, and trial manufacturing. The breakdown includes expenses related to research and development ($770,000), director fees ($39,000), employee salaries ($37,000), general corporate costs ($110,000), and audit-related expenses ($18,000). Notably, the company reported a net tax refund of $55,000 related to GST costs, reflecting its prudent financial management practices.
