Aurealis Therapeutics development pipeline
Chronic wounds · AUP-16
Diabetic foot ulcer Phase 2 complete · Phase 3 in preparation
AUP-16 · Diabetic foot ulcer
INN: Rememulgene arelactibac
The disease
Diabetic foot ulcers affect an estimated 4 million people in the US and 6.5 million in the EU. More than 60% of non-traumatic lower limb amputations are caused by non-healing DFUs, and two-year mortality is around 30% — higher than many cancers. Only 30% of chronic wounds respond to standard care, because most treatments target a single biological pathway in a disease that stalls across multiple ones simultaneously.
How AUP-16 works
AUP-16 is a topically applied multi-target gene therapy based on engineered Lactococcus cremoris. It delivers three human therapeutic proteins simultaneously into the wound microenvironment (FGF-2, IL-4, CSF-1), restarting the healing process across multiple mechanisms in a single product and a single application.
Clinical evidence
The DIAMEND AUP-16 Phase 2 DFU clinical study (64 patients, 10 sites across Italy, Germany, and Poland) showed 64% complete wound closure with AUP-16 versus 20% with placebo (Per Protocol; +44 percentage points; p < 0.05), confirmed by independent blinded evaluation. Phase 3 preparation is underway. AUP-16 holds EMA PRIME designation for non-healing DFUs (February 2024).
Venous leg ulcer Phase 2 upcoming
AUP-16 · Venous leg ulcer
INN: Rememulgene arelactibac
The disease
Venous leg ulcers are the most common chronic leg wound, driven by venous hypertension and impaired circulation. Healing is slow, recurrence is high, and a significant proportion of patients do not respond to standard compression-based care because the underlying biology of chronic inflammation is not addressed.
How AUP-16 works in venous leg ulcers
AUP-16 is a topically applied multi-target gene therapy based on engineered Lactococcus cremoris, delivering FGF-2, IL-4, and CSF-1 simultaneously into the wound microenvironment. The same multi-target mechanism that restarts healing in non-healing DFUs addresses the biological failure modes shared across chronic wound types.
Development status
Phase 1 clinical data from the DFU programme supports progression directly to Phase 2 in VLU. A Phase 2 study in venous leg ulcers is planned.
Pressure / rare ulcer Late pre-clinical
AUP-16 · Pressure / rare ulcer
INN: Rememulgene arelactibac
The disease
Pressure ulcers and other rare ulcer types arise from a range of underlying causes including sustained tissue damage due to immobility, vascular compromise, and systemic conditions. They represent an area of considerable unmet need across hospitalised, elderly, and complex patient populations, where standard care frequently fails to restart healing.
How AUP-16 works in pressure and rare ulcers
AUP-16 is a topically applied multi-target gene therapy based on engineered Lactococcus cremoris, delivering FGF-2, IL-4, and CSF-1 simultaneously. The mechanism that restarts healing in non-healing DFUs is expected to translate to pressure and rare ulcer types, where the underlying biology of stalled chronic inflammation is similar.
Development status
AUP-16 in pressure and rare ulcer indications is at late pre-clinical stage.
Oncology · AUP-55
Ovarian & peritoneal cancer Pre-clinical
AUP-55 · Ovarian & peritoneal cancer
INN: not yet confirmed
The disease
Ovarian cancer is diagnosed in approximately 314,000 women annually worldwide, with around 207,000 deaths each year. Five-year survival is below 20% for advanced-stage disease, and recurrence following standard chemotherapy remains the central clinical challenge.
How AUP-55 works in ovarian and peritoneal cancer
AUP-55 is an oncolytic-bacteria-based ATMP built on the same engineered Lactococcus cremoris platform as AUP-16, configured in fight-mode. Administered by intratumoral injection, it simultaneously activates innate and adaptive immune responses to attack and kill tumour cells across multiple mechanisms.
Pre-clinical evidence
In ovarian cancer mouse models, AUP-55 produced 90% survival versus 0% in untreated controls, with significantly reduced tumour load. Pre-clinical data were presented at the ASCO Annual Meeting, June 2023.
Bladder cancer Pre-clinical
AUP-55 · Bladder cancer
INN: not yet confirmed
The disease
Bladder cancer is among the ten most common cancers globally. Non-muscle-invasive bladder cancer carries high recurrence rates, and patients with BCG-unresponsive disease face limited effective treatment options.
How AUP-55 works in bladder cancer
AUP-55 is an oncolytic-bacteria-based ATMP on the engineered Lactococcus cremoris platform in fight-mode. Its combination of direct tumour killing and local immune activation makes it relevant to bladder cancer, where local delivery can engage the immune system without the toxicity profile of systemic therapy.
Development status
AUP-55 in bladder cancer is at pre-clinical stage.
Recurrent melanoma Pre-clinical
AUP-55 · Recurrent melanoma
INN: not yet confirmed
The disease
Recurrent melanoma remains difficult to treat despite advances in checkpoint inhibition. Patients who relapse after immunotherapy have limited subsequent options, and resistance to systemic therapy is a defining clinical challenge.
How AUP-55 works in recurrent melanoma
AUP-55 delivers multiple immune-activating components simultaneously by intratumoral injection, aiming to re-engage the immune response in tumours that have become resistant to systemic therapy. Local delivery avoids the systemic toxicity associated with conventional immunotherapy.
Development status
AUP-55 in recurrent melanoma is at pre-clinical stage.
Inflammation · AUP-60
Dermatology (undisclosed) Discovery
AUP-60 · Dermatological inflammation
INN: not yet assigned
Programme
AUP-60 is an early discovery-stage programme applying the Aurealis multi-target platform to chronic dermatological inflammation. The specific indication is undisclosed at this stage.
Platform relevance
Delivering multiple immunomodulatory proteins locally rather than systemically is particularly relevant to inflammatory skin conditions, where sustained systemic immunosuppression carries a significant side-effect burden.
Rheumatology (undisclosed) Discovery
AUP-60 · Rheumatological inflammation
INN: not yet assigned
Programme
AUP-60 is an early discovery-stage programme applying the Aurealis multi-target platform to rheumatological inflammation. The specific indication is undisclosed at this stage.
Platform relevance
Rheumatological conditions are driven by persistent, dysregulated immune activity. The Aurealis platform's capacity to deliver multiple immunomodulatory proteins locally offers a potential route to address these conditions with greater precision and a reduced systemic side-effect burden compared to current standards of care.