ArticleTherapeutic advances in endocrinology and metabolism2024
Multi-target gene therapy AUP1602-C to improve healing and quality of life for diabetic foot ulcer patients: a phase I, open-label, dose-finding study.
Article in Therapeutic advances in endocrinology and metabolism, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04281992 (A Phase 1/2A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Single and Repeated Doses of AUP1602-C as Topical Treatment of Diabetic Foot Ulcers), which is not on this map. Cited by 4 papers.
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A Phase 1/2A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Single and Repeated Doses of AUP1602-C as Topical Treatment of Diabetic Foot Ulcers
Who cites it
4 citing papers in PubMed.
- The dual role of the microbiome in chronic wound management.Cell communication and signaling : CCS · 2026Review
- Microbial allies in skin trauma recovery: from immune modulation to engineered probiotic therapeutics.Burns & trauma · 2026Review
- Developing anACS pharmacology & translational science · 2025Article
- Skin microbiota and diabetic foot ulcers.Frontiers in microbiology · 2025Review
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Authors and funding
15 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Background: Diabetic foot ulcer (DFU) is a common and highly morbid complication of diabetes with high unmet medical needs. AUP1602-C, a topical four-in-one gene therapy medicinal product (GTMP), consisting of a Objectives: The aim of this first-in-human study was to investigate whether AUP1602-C is safe and effective in improving wound healing and quality of life (QoL) in patients with non-healing DFU (nhDFU), and to determine the recommended phase II dose. Design: Phase I, single-arm, open-label, uncontrolled, dose escalation study. Methods: The study consisted of four cohorts of patients receiving AUP1602-C as a single dose of 2.5 × 10 Results: In total, 16 patients aged 53-80 years were included, 3 each in the safety and low dose, 4 in the medium dose, and 6 in the high-dose cohort. AUP1602-C demonstrated a favorable safety profile with almost 100% dosing compliance. The most frequently reported side effect related to treatment was skin maceration. No serious adverse reactions, systemic toxicity, deaths, or side effects suggestive of immunogenicity, hypersensitivity, allergic reaction, or dose-limiting toxicities related to treatment were reported. No biodistribution events were observed and shedding-related events were rare and did neither show accumulation nor dose dependency. The recommended phase II dose of 2.5 × 10 Conclusion: AUP1602-C was safe and well tolerated and demonstrated dose-dependent efficacy in patients with nhDFU. Data supports further clinical development of AUP1602-C. Trial registration: The study was registered in ClinicalTrials.gov (NCT04281992) and ClinicalTrialsRegister.eu (2018-003415-22).
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