INVEST IN MULTI-TARGET CELL & GENE THERAPIES
CHRONIC WOUNDS, CANCER, INFLAMMATION AND BEYOND
We are committed to developing curative therapies for chronic wounds, cancer, and inflammatory diseases through our innovative multi-target cell and gene therapy platform.
Our goal is to provide life-changing treatments for millions of patients worldwide by building a strong foundation of clinical safety and efficacy in treating Diabetic Foot Ulcers, chronic wounds, and deadly cancers. Through strategic partnerships, we aim to bring our platform to market, transforming healthcare and improving lives.
EXPLORE THE OPPORTUNITY
Massive unmet need and market opportunity
- Chronic Wounds: $100Bn cost to society and $15Bn global market.
- Diabetic Foot Ulcer
- Venous Leg Ulcer
- Pressure Ulcer
- Ovarian Cancer: 207,252 deaths/year and over $5Bn global market.
- Bladder Cancer: 212,536 deaths/year and over $8Bn global market.
- Inflammation: Global anti-inflammatory market to grow 4% and reach $146Bn in 2032.
- Curing complex diseases requires multi-targeting – current treatments do not enable that.
- Cell and gene therapies have therapeutic potential but cannot be scaled and COGS is unacceptable.
Aurealis Therapeutics 4-in-1 platform.
Aurealis’ technology enables multi- targeting with superior scalability and low COGS.
OUR PRODUCT PIPELINE
| Modality | Product | Discovery | In vivo POC | GLP, S&T, CMC | IND/CTA | Phase 1 | Phase 2 | Phase 3 | NDA/MAA |
|---|
CLINICAL TRIALS IN DIABETIC FOOT ULCERS
AUP-16 phase 2 currently ongoing
PHASE 1 CLINICAL STUDY IN DFU (COMPLETED)
83% of the patients achieved complete healing. No healed ulcer recurred after 12 months follow-up.
In June 2022, we successfully completed the Phase 1 study (NCT04281992 and EudraCT 2018-003415-22) in non-healing Diabetic Foot Ulcer patients with our lead product AUP-16. The last patient last visit (LPLV) was on 20th March 2023. Results were presented during EWMA 2023 conference in Milan and will be published in 2024.
Aurealis Therapeutics technology platform works in real life: non-healing diabetic wounds heal. Clinical results: 83% of patients reached complete healing, no healed ulcer recurred after 12 months follow-up.
More details about our Phase 1 Clinical Study:
NIH National Library of Medicine record
More details about our Phase 1 Clinical Study:
EU Clinical Trials Register
PHASE 2 CLINICAL STUDY IN DFU (ONGOING)
AUP-16 DIAMEND Phase 2 RCT in Diabetic Foot Ulcer ongoing in Germany, Italy and Poland.
AUP-16 Phase 2 study (NCT06111183 and EudraCT 2022-502048-10-00) in DFU received CTA approval in May 2023; the first DFU patient was dosed in August 2023; patient recruitment was successfully completed in August 2024. The DIAMEND study is a multi-center, single-blinded, randomized, standard-of-care plus placebo-controlled study in patients with non-healing diabetic foot ulcers, conducted in Germany, Italy and Poland.
More details about our DIAMEND Phase 2 Clinical Study:
NIH National Library of Medicine record
More details about our DIAMEND Phase 2 Clinical Study:
EU Clinical Trials Register
