InhaleRx Ltd (ASX:$IRX) announcement overview

InhaleRx Ltd (ASX:IRX) has announced its decision to nominate Breakthrough Cancer Pain (BTcP) as the primary area of focus for the proposed Phase 2 clinical trial of IRX211, a cannabinoid derived drug delivered via inhalation. The decision follows a detailed evaluation process and feedback from the US Food & Drug Administration (FDA) in March 2023. The company aims to provide therapeutic solutions in a cost-effective and time-efficient manner, with the overarching goal of achieving a New Drug Approval (NDA) with the FDA.

Executive commentary on the pivot to breakthrough cancer pain

CEO, Mr Darryl Davies said; 'IRX's ability to be nimble has served as a significant advantage in this particular case. Feedback from the FDA from earlier in 2023 resulted in a comprehensive review of potential alternative pain indications. This work has provided us with confidence that BTcP will provide a combination of primary endpoints that are better suited to the characteristics of IRX211 (compared with those of CRPS), resulting in a better-established pathway with a resultant increase in the probability of success.' IRX's Chief Scientific Officer, Dr Rob Jenny, said 'We are excited to apply the learnings made while exploring the orphan disease CRPS as a drug development target to the much larger BTcP patient population.'

Summary of InhaleRx Ltd's pivot and outlook

InhaleRx Ltd (ASX:IRX) has strategically pivoted to focus on Breakthrough Cancer Pain (BTcP) as the primary indication for the proposed Phase 2 clinical trial of IRX211, citing established indication, FDA vouchers, multiple approvals, larger patient population, and commercial opportunity as key supporting points. The company aims to capture a significant share of the non-opioid cancer pain market with IRX211, which is a cannabinoid derived drug delivered via inhalation. The decision is expected to result in significant time and cost savings across the clinical development timeline. IRX's overarching goal remains to achieve a New Drug Approval (NDA) with the FDA, and it plans to explore opportunities for the application of IRX211 for Complex Regional Pain Syndrome (CRPS) in the future.