CLINICAL TRIALS

AUP-16 FOR DIABETIC FOOT ULCERS (DFUs)

PHASE 1 AUP-16 CLINICAL STUDY IN DFUs (COMPLETED)

In June 2022, we successfully completed the Phase 1 study in non-healing Diabetic Foot Ulcer patients with our lead product AUP-16. The last patient last visit (LPLV) was on 20th March 2023. Results were presented during EWMA 2023 conference in Milan and will be published in 2024.

Aurealis Therapeutics technology platform works in real life: non-healing diabetic wounds heal. Clinical results: 83% of patients reached complete healing, no healed ulcer recurred after 12 months follow-up.

83% of patients achieved complete healing no healed ulcer recurred after 12 months follow-up

More details about our Phase 1 Clinical Study:
NIH National Library of Medicine record

More details about our Phase 1 Clinical Study:
EU Clinical Trials Register

PHASE 2 AUP-16 CLINICAL STUDY IN DFUs (ONGOING)

AUP-16 Phase 2 study in DFU received CTA approval in May 2023; the first DFU patient was dosed in August 2023. In March 2024, Aurealis Therapeutics announced the successful recruitment and randomization of half of the patients expected to participate in the study. The DIAMEND study is a multi-center, single-blinded, randomized, standard-of-care plus placebo-controlled study in patients with non-healing diabetic foot ulcers, conducted in Germany, Italy and Poland.

AUP-16 DIAMEND PHASE 2 RCT IN DFU ONGOING IN GERMANY, ITALY AND POLAND

More details about our DIAMEND Phase 2 Clinical Study:
NIH National Library of Medicine record

PHASE 2 CLINICAL STUDIES IN VENOUS ULCER AND PRESSURE ULCER WILL FOLLOW

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