Major Milestone Achieved for Breakthrough Cancer Pain Treatment

Melbourne, Australia – InhaleRx Limited (ASX: IRX), a healthcare innovator focused on inhaled drug-device treatments, announced today that it has secured Human Research Ethics Committee (HREC) approval to commence a Phase 2 clinical trial of its novel therapy, IRX-211. This milestone marks a significant step in addressing Breakthrough Cancer Pain (BTcP) with a potentially safer, non-opioid alternative.

Addressing Unmet Needs in Breakthrough Cancer Pain

BTcP represents a pressing challenge for cancer patients worldwide due to its sudden onset and intensity. The Total Addressable Market (TAM) for BTcP is estimated to exceed USD 1 billion annually. Current treatments, predominantly opioid-based, such as fentanyl, present significant risks including dependency, respiratory depression, and cognitive impairment. IRX-211 aims to offer rapid pain relief without these adverse effects, leveraging a cannabinoid-based formulation designed for efficacy and safety.

Significance of Phase 2 Clinical Trial Approval

The Bellberry HREC approval enables InhaleRx to move forward with its Phase 2 trial, evaluating the safety, efficacy, and dosing of IRX-211 for BTcP patients. This follows the successful completion of a Phase 1 trial earlier in 2024, where the treatment demonstrated excellent tolerability and a favorable pharmacokinetic profile. The Phase 2 trial is expected to commence in Q2 2025, focusing on further validating the therapeutic potential of IRX-211 in a larger patient population.

IRX-211: A Breakthrough in Cancer Pain Management

With opioid-based treatments being phased out in some markets due to risks and side effects, IRX-211 presents an opportunity to redefine BTcP management. The therapy is positioned to fill the void left by discontinued products like Transmucosal Immediate-Release Fentanyl (TIRF). By delivering rapid-onset relief without the dangers of opioid dependency, IRX-211 could transform the quality of life for cancer patients globally.

CEO Commentary

Darryl Davies, CEO of InhaleRx, stated:
“Securing HREC approval for the Phase 2 clinical trial of IRX-211 is a pivotal moment for InhaleRx. We are driven by the mission to provide safer, effective solutions for breakthrough cancer pain. IRX-211 has the potential to revolutionize how BTcP is treated, offering rapid relief without the risks of opioids. This milestone underscores our commitment to addressing a critical unmet medical need.”

Strategic Pathway to FDA Approval

InhaleRx is pursuing a streamlined regulatory pathway through the U.S. FDA’s 505(b)(2) approval process. This approach leverages existing data to accelerate market entry, reducing both time and cost compared to traditional drug development routes. With a robust foundation of intellectual property, including innovation and provisional patents, the company is well-positioned to bring IRX-211 to market efficiently.

Looking Ahead

The Phase 2 trial represents a crucial phase in the development of IRX-211, bringing it closer to addressing the urgent needs of BTcP patients. InhaleRx is committed to leveraging its innovative platform to deliver solutions that enhance patient outcomes while capturing a significant share of the growing pain management market.