Basel Switzerland, Kuopio Finland – November 17th, 2020.
Aurealis Therapeutics, a private clinical-stage biopharmaceutical company, is making a difference in chronic, non-healing wounds by developing a therapy with multiple active substances in one product that are hitting all key pathomechanisms. Chronic wound care needs curative drugs with true active pharmaceutical substances, not just incrementally improved dressings and devices. The company announced today that it has initiated the repeated dosing groups with therapeutic dose levels of AUP-1602 in the diabetic foot ulcer (DFU) patient trial. The first AUP-1602 treated patients with a non-healing DFU have been enrolled for the study and successfully dosed with AUP-1602.
“Earlier in the year the single administration safety dose group was successfully finalized without any adverse effects detected, already indicating clean safety and tolerability record. In addition, the health authorities in Germany and Poland approved our amendments to the clinical study protocol (including a Risk Mitigation Plan) to minimize the risks to the patients of infection during the COVID19 pandemic during this phase 1 DFU patient study. This allowed us to advance to the repeated dosing cohorts with therapeutic AUP-1602 dose levels. We are looking forward to recruit patients for this dose escalation study and to generate safety, tolerability and preliminary efficacy data based on which the recommended phase 2 dose and frequency will be determined” said CSO Thomas Wirth.
“Exciting times ahead as data starts to accumulate. We are encouraged that no drug related adverse effects have been seen. Our team and close collaborators, with the great support from our investor base, have worked with passion and dedication to get here. I am grateful and proud of the team and beyond of being able to test our unique scientific hypothesis in the patients who truly need new curative treatment options” continued CEO Juha Yrjänheikki.
AUP-1602 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-1602 is topically applied on chronic wounds and covered by wound dressing (e.g. in DFU, venous leg ulcers and pressure ulcers). In the wound AUP-1602 acts as millions of immune activating bioreactors producing the therapeutic proteins, which are designed to i) halt the chronic inflammation in the wound and promote M2 inflammatory switch, ii) induce the growth of new blood vessels, and iii) promote the granulation tissue formation and skin re-epithelization – all in one product.
AUP-1602 Clinical Plan
Study AP-W-CLI-2018-8 (EudraCT number: 2018-003415-22, ClinicalTrials.gov Identifier: NCT04281992) is the first clinical study of AUP-1602 in humans – in non-healing DFU patients. 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-1602 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, standard-of-care controlled study of the recommended AUP-1602 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