Diabetic Foot Ulcer patient trial of genetically modified bacterial cell therapy
Preliminary results show promising response to our four-in-one therapeutic wound treatment in diabetic foot ulcer patients
DFU Clinical Trial
Our first-in-human clinical trial of AUP-16 commenced in early 2020 in Germany and Poland as a phase 1/2A trial for diabetic foot ulcer (DFU) patients. After a temporary interruption due to COVID-19, repeated dosing, dose escalation studies resumed in September 2020. AUP-16 has undergone extensive safety and toxicity studies, as well as pharmacokinetics analysis in preparation for this clinical trial.
We worked extensively with our clinical research partners and advisors to facilitate patient selection and design of the study protocol, ensuring all necessary safety guidelines were in place. We were able to continue the study despite COVID-19 restrictions using carefully implemented safety protocols, logistics and nursing services to help patient participation.
Our clinical trial site in Poland is seeking type 1 or 2 diabetic patients with chronic non-healing diabetic foot ulcer (DFU) to participate in an international multicentre medical clinical trial. To learn more about this visit https://www.mikomed.pl/badanie-kliniczne-dla-pacjentow-z-owrzodzeniem-stopy-cukrzycowej/
Faster and total wound healing
Our aim is to significantly improve the standard of care in the treatment of non-healing wounds. To this end, our clinical program is focusing on the primary objectives of:
Determining safety, tolerability and recommended dosage and schedule for single and repeated topical administrations of AUP-16 in patients with chronic DFUs
Assessing the efficacy of multiple administrations of AUP-16 in DFU patient:
- Reduction in wound area, depth and volume
- Reduction in time to complete wound closure
- Decreases in ulcer recurrence
- Decreases in amputation rate
- Decreases in infection rate
- Positive effect on patient’s quality of life and pain perception
Pre-clinical Results show that application of AUP-16 in non-healing diabetic mouse wound models and in vitro human cell assays leads to.
We are now actively moving to increasing the therapeutic dose of AUP-16. As the trial results come in, we will be excited to share those results with the clinical community. AUP-16 can be expanded to other chronic wounds such as venous leg ulcer, pressure ulcer, burn wounds, and to chronic inflammatory/regenerative indications.