Interview with Hanna-Riikka Kärkkäinen Head of Quality and Regulatory Affairs at Aurealis Therapeutics | Professional career, AUP-16 PRIME designation, FDA Advice & more

What was the journey that took Hanna-Riikka Kärkkäinen to her current role as Head of Quality and Regulatory Affairs? What does having the PRIME designation for AUP-16 mean? What was the result of the FDA Advice that Aurealis had with respect of AUP-16? How are the preparations to take AUP-16 to the world moving forward? […]

Half of the Patients Successfully Recruited and Randomized in Aurealis Therapeutics DIAMEND AUP-16 Phase-2 Study

Zug, Switzerland and Kuopio, Finland, March 11, 2024. Aurealis Therapeutics, a Swiss-Nordic clinical-stage company developing scalable and low COGS multi-target cell and gene therapies, announced today the successful recruitment and randomization of half of the patients expected to participate in its DIAMEND AUP-16 Phase-2 clinical trial on Diabetic Foot Ulcers (DFUs). AUP-16 is Aurealis Therapeutics’ […]

Aurealis Therapeutics Receives Priority Medicines (PRIME) Designation from EMA for Enhanced Regulatory Support and Accelerated Assessment of AUP-16 in Non-healing Diabetic Foot Ulcers

Priority medicines (PRIME) is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. The scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach […]

AUP-16: More cost-effective than the current Standard Of Care at healing Diabetic Foot Ulcers revealed at ISPOR Europe 2023

Aurealis Therapeutics, a Swiss-Finnish clinical-stage synthetic biology company developing bacteria-based multi-target cell and gene therapies for chronic wounds and cancer, participated in ISPOR Europe Health Economics and Market Access conference held from 12-15 November in Copenhagen, Denmark. During this conference, Laurent Décory, COO of Aurealis Therapeutics, presented one of the company’s latest developments: a detailed […]

Aurealis Therapeutics launches Venous Leg Ulcer (VLU) scientific expert group, an important step towards AUP-16 VLU phase 2 clinical trial

Aurealis Therapeutics, a Swiss-Finnish clinical-stage synthetic biology company developing bacteria-based multi-target cell and gene therapies for chronic wounds and cancer, announces the initiation of its Venous Leg Ulcer (VLU) scientific expert group. This initiative is an important step towards the planning and execution of the Phase 2 clinical trial of AUP-16 for Venous Leg Ulcers […]

Aurealis Therapeutics announces first patient dosed in DIAMEND Phase 2 Diabetic Foot Ulcer clinical trial of AUP-16

Aurealis Therapeutics, a Swiss-Finnish clinical-stage synthetic biology company developing bacteria-based multi-target cell and gene therapies for chronic wounds and cancer, announced today that the first diabetic foot ulcer (DFU) patient has been successfully dosed in its DIAMEND phase 2 clinical study of AUP-16. This is a multi-center, single-blinded, randomized, standard-of-care plus placebo-controlled clinical trial that […]

Aurealis Therapeutics presented advancements in multi-target bacterial gene therapies at the 14th International Symposium on Lactic Acid Bacteria

Aurealis Therapeutics, a Swiss-Finnish clinical-stage synthetic biology company developing bacteria-based multi-target cell and gene therapies for chronic wounds and cancer, is making remarkable advances in the field with its 4-in-1 technology platform. Director of Genetic Engineering & Manufacturing, Igor Mierau, showcased the company’s research and results at the 14th International Symposium on Lactic Acid Bacteria, held […]

Aurealis Therapeutics shines in Nordic Life Science News with in-depth interview on gene therapy innovations

Aurealis Therapeutics, a Swiss-Finnish clinical-stage synthetic biology company creating bacteria-based multi-factor cell and gene therapies for chronic wounds and cancer, is excited to share its recent feature in the well-known life science journal, Nordic Life Science News. The article titled “From Theory to Therapy: Gene Therapy” has shared remarkable insights from an interview with Laurent Décory, COO […]

Aurealis Therapeutics strengthens its Board of Directors by appointing Jean de Gunzburg as a new member

Aurealis Therapeutics, a Swiss-Finnish clinical-stage synthetic biology company creating bacteria-based multi-factor cell and gene therapies for chronic wounds and cancer, announced today that Jean de Gunzburg, Scientist and Investor, Founder and Chairman of Zagdanut Ltd, Director of Cardiawave SA, previously CSO and Director of Da Volterra, and Founder and Chairman of Metsya Ltd, has been […]