InhaleRx advances Phase 2 trial for breakthrough cancer pain treatment

InhaleRx (ASX:IRX) has executed a study order with iNGENū CRO to oversee its Phase 2 clinical trial for IRX-211, a non-opioid treatment for breakthrough cancer pain.

The appointment of iNGENū, approved by shareholders at a recent general meeting, marks a key step in advancing the trial following a successful Phase 1 study.

The trial is fully funded under a $38.5 million facility with Clendon Biotech Capital, enabling InhaleRx to accelerate its clinical development efforts.

IRX-211 is designed as a rapid-onset, inhaled alternative to opioids for managing BTcP, which is characterised by intense, short-duration pain episodes despite background opioid treatment.

The Phase 2 trial will be a double-blind, placebo-controlled, multicenter, cross-over study with a titration period, enrolling opioid-tolerant BTcP patients.

Participants who respond effectively in the open-label portion will proceed to the double-blind phase.

The primary objective is to assess the safety, efficacy, and tolerability of IRX-211 for rapid pain relief.

BTcP presents a challenge in cancer pain management, as its sudden onset and severity often render standard treatments insufficient. 

InhaleRx CEO Darryl Davies commented, "The execution of this study order for the IRX-211 Phase 2 trial represents a major milestone in our mission to provide cancer patients with a safe, effective, fast-acting therapy for breakthrough pain that does not further contribute to reliance on opioid-based medications."

Preparations are underway to commence the trial, with a focus on coordinating batch manufacturing with a GMP-certified facility in Sydney.

At the time of reporting, InhaleRx's share price was $0.040.