Aurelix Bio is a clinical-stage biotechnology company advancing a Phase 2b trial of Mirabegron, a repurposed β3-adrenergic receptor agonist, for a cardiovascular indication with limited treatment options. The company focuses on well-characterized molecules with established safety profiles to compress development timelines while maintaining scientific rigor. Its randomized, double-blind, placebo-controlled trial is enrolling across multiple Australian sites under the TGA's clinical trial framework.
Funding
Funding not disclosed
Founders
Product
Problem
Cardiovascular diseases remain a leading cause of mortality, yet many patients lack effective treatment options for specific cardiac conditions where standard-of-care is inadequate. Existing therapies often carry significant side-effect profiles or demonstrate limited efficacy, leaving a substantial unmet medical need for novel approaches that can be developed efficiently and safely.
Solution
Aurelix Bio is a clinical-stage biotechnology company repurposing Mirabegron, a β3-adrenergic receptor agonist with an established global safety profile, for a cardiovascular indication where current therapeutic options are limited. The company's lead programme, AUX-001, is currently in a Phase 2b randomized, double-blind, placebo-controlled trial designed to characterize dose response, define the registrational endpoint, and de-risk the path to a pivotal Phase 3 study. By working exclusively with molecules that have validated human safety, pharmacokinetic, and tolerability profiles, Aurelix compresses development timelines without compromising scientific rigor. The company conducts trials in Australia under the TGA's clinical trial framework, leveraging world-class investigators and regulatory pathways that translate to FDA and EMA submissions.
Target Audience
Primary stakeholders are regulatory agencies and clinical investigators involved in cardiovascular drug development, along with patients who have cardiac conditions lacking adequate therapeutic options. The company also engages with cardiology specialists and research institutions participating in the Phase 2b trial.
Features
- Repurposing Mirabegron, a β3-adrenergic receptor agonist with years of post-marketing safety data, for a novel cardiac indication
- Phase 2b trial designed as a randomized, double-blind, placebo-controlled study to establish dose response and registrational endpoints
- Oral, once-daily dosing formulation leveraging the compound's established pharmacokinetic profile
- Multi-site trial conducted across leading Australian centres under the TGA's CTN scheme
- Indication selection driven by mechanistic plausibility, absence of effective standard-of-care, and clear regulatory pathway
- Development strategy focused on molecules with established human safety and tolerability to accelerate clinical timelines