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Clinical Research

(CR-044) Final Results of Phase-2 Randomised Controlled « DIAMEND » Study In Chronic Diabetic Foot Ulcer With Topical Multi-Target Cell & Gene Therapy AU1602-C

Friday, April 10, 2026
Jacek Mikosiński, MD – Mikomed Klinik, Łódź; Elisabetta Iacopi, MD – Azienda Ospedaliera Universitaria, Pisa; Dirk Lammers, MD – Zentrum für Diabetes und Gefäßerkrankungen, Münster; Christine Kosch, MD – Diabetologische Schwerpunktpraxis, Pirna; Konrad Pańczak, MD – Lecran Centrum Opieki Nad Ranami, Wrocław; Malwina Grobelna, MD – Med-Polonia SP. Z O.O., Proznan; Matteo Monami, MD – Azienda Ospedaliero Universitaria Careggi, Firenze; Alessia Scatena, MD – Azienda Usl Toscana Sud Est, Arezzo; Marcin Malka, MD PhD – PODOS Klinika Leczenia Ran, Warsaw; Marco Meloni, MD PhD – University of Rome Tor Vergata, Roma; Christoph Schindler, MD – Hannover Medical School, Hannover; Mirka Sanio, RN – Aurealis Therapeutics, Kuopio; Jere Kurkipuro, PhD – Aurealis Therapeutics, Kuopio; Hanna-Riikka Kärkkäinen, MSc – Aurealis Therapeutics, Kuopio; Matleena Piiroinen, MSc – Aurealis Therapeutics, Kuopio; Igor Mierau, PhD – Aurealis Therapeutics, Kuopio; Laurent Décory, PhD MBA – Aurealis Therapeutics, Zug; Juha Yrjänheikki, PhD – Aurealis Therapeutics, Zug; Haritha Samaranayake, MD PhD – Aurealis Therapeutics, Kuopio
Introduction:

AUP1602-C is a Microbial Vector used for Gene Therapy (MVGT) which has been shown to modulate inflammation, stimulate tissue repair, and restore healing in patients with non-healing diabetic foot ulcers (DFU)1,2. Safety and efficacy of multi-target MVGT  AUP1602-C in chronic DFUs has been evaluated in a multi-center, randomized, controlled Phase 2 trial.

Methods: AUP1602-C (INN: Rememulgene arelactibac) consists of living Lactococcus cremoris bacteria genetically engineered to secrete human Fibroblast 2 (h-FGF-2), Interleukin 4 (h-IL-4) and Colony Stimulating Factor 1 (h-CSF-1), and promote wound healing by microenvironment modulation1. Following a successful Phase-1 study (NCT04281992 / EudraCT 2018-003415-22)2, safety and efficacy AUP1602-C were evaluated in a 64-patient, standard-of-care (SoC) plus placebo-controlled patient and central-evaluator blinded, Phase-2 “DIAMEND” study (NCT06111183 / EU CT 2022-502048-10-00). DIAMEND study was conducted in 10 clinical centers in Germany, Italy and Poland. AUP1602-C was administered topically once- or twice-a-week to non-healing, neuro-ischemic DFUs until complete wound closure or maximum for 12-weeks, along with SoC, provided according to IWGDF guidelines. Efficacy endpoints included completed healing and wound area reduction at 20-weeks, with post-hoc focus on chronic ulcers over 3-months old.

Results: In Intention-To-Treat (ITT) population, complete wound closure rate was 55% and 30% in AUP1602-C twice-a-week and once-a-week groups respectively, and 29% in the placebo group (+26% between placebo and AUP1602-C twice a week, p >0.05). In Per Protocol Population (PP), complete closure rates were 56%, 32% and 26% respectively (+30%, p >0.05). Focusing on chronic ulcers above 3 months old, complete closure rates were 60%, 28% and 24% (+36%, p≤0.05, statistically significant) in ITT Population, and 64%, 29%, 20% (+44%, p≤0.05, statistically significant) in PP Population. No serious adverse reactions or safety concerns related to AUP1602-C were observed.

Discussion: In first-ever Phase-2 study with a topical gene therapy, AUP1602-C demonstrated the potential to be superior to SoC in treating non-healing, neuro-ischemic DFUs in patients with chronic ulcers over 3-months old. Preparation for a global pivotal study in this target population is under way.