Aurealis Therapeutics, a clinical-stage Swiss-Finnish company developing multi-target cell and gene therapies for chronic wounds and cancer, is pleased to announce that the last patient in its DIAMEND AUP-16 Phase 2 clinical trial on Diabetic Foot Ulcers (DFUs) has completed treatment. This important milestone marks the end of the treatment phase and initiates a 12-month follow-up period to further assess safety, tolerability, and efficacy of AUP-16.
The DIAMEND Phase 2 clinical trial (Study ID: AT-W-CLI-2022-04, NCT06111183 and EudraCT number: 2022-502048-10-00) is a multi-centre, patient and observer blinded, randomized, standard-of-care plus placebo-controlled study being conducted at clinical sites in Italy, Germany, and Poland. The study is designed to evaluate the safety, tolerability, and efficacy of AUP-16 as a topical therapy for non-healing neuro-ischemic DFUs at the recommended Phase 2 dose across two dosing frequencies during a 12-week treatment period. AUP-16 received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) in recognition of its potential to address the significant unmet medical need of chronic DFUs.
“We are proud to announce the completion of treatment for the last patient in our DIAMEND Phase 2 clinical trial. We are truly grateful to the patients and their families for their participation and trust, as well as to the clinical teams for their commitment and continuous dedication,” said Haritha Samaranayake, MD, PhD, Chief Medical Officer of Aurealis Therapeutics. “Completing the treatment for all patients brings us one step closer to our goal of improving the lives of patients who are affected by non-healing DFUs.”
“This milestone is the result of the collective efforts of everyone involved—from our internal team to our CROs, clinical sites and investigators who have made this trial possible,” added Mirka Sanio, Clinical Operations Director. “We are excited to move forward, focusing on analysing the data collected, and eager to see the impact AUP-16 may have on healing non-healing DFUs.”
Diabetic foot ulcers affect millions of people worldwide, causing chronic pain, infection risks, amputations, and even death in severe cases. Traditional therapies often fall short in addressing the complex nature of DFUs. AUP-16, a genetically engineered Lactococcus Cremoris, produces human therapeutic proteins designed to halt inflammation, stimulate new blood vessel growth, and promote wound healing – all within a single, topically applied product.
As the DIAMEND trial moves into its final phase of data collection and analysis, Aurealis Therapeutics continues to advance its mission of develop innovative therapies for chronic wounds, cancer and beyond.
About AUP-16
AUP-16 is a genetically engineered Lactococcus Cremoris, a non-pathogenic, probiotic bacteria, expressing human basic fibroblast growth factor (FGF-2, bFGF), interleukin-4 (IL-4) and macrophage colony stimulating factor (CSF-1, mCSF) – all in one product and accepted as one active pharmaceutical ingredient from regulatory perspective. AUP-16 is topically applied on chronic wounds and covered by wound dressing (e.g. in diabetic foot ulcers, venous leg ulcers or other ulcer types). In the wound AUP-16 acts as millions of bioreactors producing the therapeutic proteins, which are designed to i) halt chronic inflammation in the wound, ii) induce growth of new blood vessels, and iii) promote granulation tissue formation and skin re-epithelization – all in one product.
About Aurealis Therapeutics
Aurealis Therapeutics AG is a Swiss-Finnish clinical-stage company developing scalable and low COGS multi-target cell and gene therapies allowing to modulate tissue microenvironment and tackle complex multi-factorial diseases such as chronic wounds, cancers, and inflammation. Aurealis modular gene therapy platform consists of non-pathogenic food-grade lactic acid bacterium Lactococcus Cremoris, genetically engineered to produce and release multiple human therapeutic proteins in the body: cytokines, chemokines, growth factors, antibody fragments. These living bacterium act as millions of nanoscale bioreactors at the site of the disease, allowing multi-targeting as one product, to treat multifactorial diseases. Aurealis pipeline includes Chronic Wounds (AUP-16, ongoing Phase 2), Oncology (AUP-55, pre-clinical stage), Inflammation (AUP-60, discovery stage).
For more information:
Laurent Décory, COO
Email: laurent@aurealistherapeutics.com
