Basel Switzerland, Kuopio Finland – September 27th, 2019.
Aurealis Therapeutics, a private biopharmaceutical company developing AUP-16, the three-in-one combination biologic drug for chronic non-healing wounds and regenerative diseases, announced today clinical trial application (CTA) approval of the AUP-16 phase 1 diabetic foot ulcer (DFU) patient trial by the German Health Authority Paul-Ehrlich-Institute. The company plans to enroll the first patient to the phase 1 DFU patient trial in three months.
“This CTA approval is obviously a major milestone for the company and an exceptional moment for the synthetic biologics industry as this presents globally the first time ever to get an approval for a therapeutic product genetically modified to produce three human therapeutic proteins in the diseased tissue. We are looking forward to initiating the patient enrollment and committed to the clinical development in general as non-healing diabetic wounds remain a severe complex disease with no effective therapies” said Dr. Juha Yrjänheikki, CEO of Aurealis Therapeutics AG.
“It is far from trivial to develop a product like this from discovery lab to the patients in five and a half years. I am extremely proud of our team and all R&D, regulatory and quality control collaborators for developing a clinical grade and scalable ATMP gene therapy product with extremely competitive cost-of-goods” continued Dr. Thomas Wirth, CSO and Chairman of the Board of Aurealis Therapeutics AG.
AUP-16 Clinical Plan
Study AP-W-CLI-2018-8 (EudraCT number: 2018-003415-22) is the first clinical study of AUP-16 in humans. It is a Phase 1-2A clinical study to evaluate the safety, tolerability and efficacy of a single and repeated doses of AUP-16 as topical treatment of DFU. The Phase 1 part will be a multicenter, open-label, non-randomized, uncontrolled dose-finding study with sequential dose escalations performed in dose cohorts comparing three doses of AUP-16 administered three times per week (low, medium, and high dose cohorts).
The Phase 2A part, an extension of the Phase 1, will be a multi-center, open-label, randomized, placebo-controlled study of the recommended AUP-16 dose and administration schedule from Phase 1 to confirm safety and to assess efficacy of the selected recommended phase 2 dose and schedule in DFU patients.
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AUP-16 is a genetically engineered Lactococcus lactis, a non-pathogenic, probiotic bacteria, expressing human basic fibroblast growth factor (FGF2, bFGF), interleukin-4 (IL4) and macrophage colony stimulating factor (CSF1, mCSF) – all in one product and accepted as one active pharmaceutical ingredient from regulatory perspective. AUP-16 is topically applied on chronic wounds and covered by wound dressing (e.g. in diabetic foot ulcers, venous leg ulcers and pressure ulcers). In the wound AUP-16 acts as millions of bioreactors producing the therapeutic proteins, which are designed to i) halt chronic inflammation in the wound, ii) induce growth of new blood vessels, and iii) promote granulation tissue formation and skin re-epithelization – all in one product.