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Aurealis Therapeutics receives PRIME designation from EMA

personalized medicine

The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Aurealis Therapeutics’ lead product candidate AUP-16 for the treatment of non-healing Diabetic Foot Ulcers (nhDFU).

“With the PRIME status and support by EMA, we aim to expedite the further development of AUP-16 program to bring a novel therapeutic option for patients suffering from nhDFU, and bring Aurealis multi-target gene therapies faster to market. This is the result of a fantastic cross-functional collaboration,” says Hanna-Riikka Kärkkäinen, Head of Quality and Regulatory Affairs of Aurealis Therapeutics.

Read more: From theory to therapy: Gene therapy


AUP-16 multi-target gene therapy is a potential first-in-class therapeutic approach which comprises a synergistic combination of four therapeutic components in one pharmaceutical ingredient (API). AUP-16 consists of Lactococcus Cremoris bacterium, genetically engineered to produce, and release three human therapeutic proteins in the wounds: fibroblast growth factor 2 (FGF-2), interleukin 4 (IL-4) and colony stimulating factor 1 (CSF-1). AUP-16 bacterium act as millions of nanoscale bioreactors in the wound, allowing to re-start and accelerate the healing of chronic wounds by 1) awakening the immune microenvironment, 2) driving macrophage conversion from pro-inflammatory M1 to anti-inflammatory and regenerative M2 phenotype, 3) granulation tissue formation by increasing fibroblast proliferation and promoting angiogenesis, and 4) supporting epithelialization.

Read more: Aurealis Therapeutics enters into 139 million USD agreement with Xbiome

The product candidate is currently being investigated in an ongoing international, randomized, placebo-controlled Phase-2 study that aims to evaluate the safety, tolerability, and efficacy of AUP-16 in non-healing neuro-ischemic diabetic foot ulcers.

Phase I study

The designation is based on positive data from completed Phase-1 study that was presented at the European Wound Management Association conference in May 2023. The results showed a dose-dependent improvement in wound closure, with the highest dose achieving 67% and 83% wound closure at 3 and 6 months respectively. According to EMA, the high rate of wound closure sufficiently demonstrates the potential of AUP-16 to address the unmet medical need in nhDFU to a significant extent.

Photo: iStock