AUP-16 received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) in February 2024 for its potential to address the significant unmet medical need of chronic DFUs.

“Our study delivered exceptional results in patients with long-standing, non-healing DFUs, reinforcing the promise of our therapy. This success drives us confidently toward the pivotal trial and global partnership discussions,” says Juha Yrjänheikki, CEO of Aurealis Therapeutics.

The DIAMEND study

The DIAMEND study is a multi-center, patient- and observer-blinded, randomized, standard-of-care plus placebo-controlled trial designed to evaluate the safety, tolerability and efficacy of AUP-16 as a topical therapy for DFUs across two dosing frequencies. The study was conducted at ten clinical sites across Italy, Germany and Poland. In total, 64 patients were randomized for treatment.

Final Blinded Evaluator data showed 3.2-fold increase in complete wound closure rate between placebo (20%) and AUP-16 administered twice weekly (64%), demonstrating a clinically and statistically significant advantage (+44% absolute increase, p value < 0.05) in chronic DFUs with prior wound duration of more than three months (Per Protocol – PP – Population). In Intention-to-Treat (ITT) population, complete wound closure rate was 2.5-fold increased by AUP-16 (+36% absolute increase, p value < 0.05). Wound Area Remaining at 20 weeks was 7.8 times lower in PP population (6.1% vs 47.4% in AUP-16 vs placebo, respectively) and 7.2 times lower in ITT population (6.2% vs 44.4% in AUP-16 vs placebo, respectively).