Aurealis Therapeutics, a clinical-stage Swiss-Finnish company developing multi-target cell and gene therapies for chronic wounds and cancer, announced today the successful completion of patient recruitment in its DIAMEND AUP-16 Phase-2 clinical trial on Diabetic Foot Ulcers (DFUs). This achievement is an important milestone in the evaluation of AUP-16’s potential to address the unmet medical needs of patients suffering from chronic DFUs.
AUP-16, Aurealis Therapeutics’ lead candidate for the treatment of chronic wounds, received PRIME designation from EMA in non-healing DFUs last February. The DIAMEND phase 2 clinical trial (Study ID: AT-W-CLI-2022-04, NCT06111183 and EudraCT number: 2022-502048-10-00) is a multi-center, single-blinded, randomized, standard-of-care plus placebo-controlled study being conducted in Italy, Germany, and Poland. The trial aims to assess the safety, tolerability, and efficacy of AUP-16 at the recommended phase 2 dose across two dosing frequencies during a 12-week treatment period. The completion of patient recruitment brings the study closer to determining AUP-16’s therapeutic impact on these challenging, non-healing wounds.
Diabetic foot ulcers are a major global health concern, affecting millions of people worldwide. These chronic wounds can lead to severe complications, such as infections, amputations, and even death. DFUs also significantly reduce patients’ quality of life due to pain, immobility, and emotional distress. Addressing this challenge requires innovative solutions, and AUP-16 represents a promising candidate by offering a multi-target approach to wound healing.
“We are pleased to announce the successful completion of patient recruitment in our DIAMEND phase 2 clinical trial for AUP-16. This is a very important milestone in the clinical development process, and we are eager to see the upcoming data from the study,” commented Haritha Samaranayake, MD, PhD, Chief Medical Officer of Aurealis Therapeutics. “We are grateful for the dedication of the investigators, clinical sites, service providers, and, of course, the patients and their families who made this possible.”
“We are encouraged by the progress of our DIAMEND trial and the quality of the collaboration between our teams and clinical partners. This achievement reflects the strong commitment of everyone involved, and we look forward to the next steps in the trial as we advance towards bringing AUP-16 closer to patients in need,” added Mirka Sanio, Senior Clinical Project Manager.
With patient recruitment now complete, Aurealis Therapeutics will continue to focus on data collection and analysis. The findings from this data are highly anticipated, and further updates will be shared as the study progresses toward its next milestones.
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
