Basel Switzerland, Kuopio Finland – May 27th, 2021.
Aurealis Therapeutics, a biopharmaceutical company developing its groundbreaking four-in-one technology -based product AUP-16, announced today that it has successfully completed the low therapeutic dose cohort in the diabetic foot ulcer (DFU) patient trial and has already enrolled and dosed the first patients in the medium therapeutic dose cohort. The primary endpoint of this dose escalation study in non-healing DFU patients is to evidence the safety and tolerability of the product and to determine the recommended phase 2 dose. The secondary endpoint of the study is the efficacy of the product.
“We are extremely happy about the positive results generated in the low-dose cohort and being able to proceed to the next therapeutic dose level. No drug related adverse effects have been seen indicating excellent safety and tolerability profile. Moreover, although not a primary endpoint, we saw response to AUP-16 treatment in all patients already with this low therapeutic dose, which in the non-clinical studies was not determined as optimal dose for efficacy. Because all wounds in this cohort were identified as non-healing wounds (as an inclusion criteria) – one patient had the wound already for two years – this is very encouraging. We are looking forward to recruit patients to the next cohorts and to reach by the end of this year the safety, tolerability and preliminary efficacy data, based on which the recommended phase 2 dose and frequency of application will be determined” said CSO Thomas Wirth.
“We want to express our gratitude to the whole team, internal and external, for executing the trial so professionally and diligently during the challenging COVID-19 era. We are encouraged by the data accumulated, confident in executing our DFU focused plan, and pleased to see the growing excitement and activity in the business development and licensing market. DFU and other non-healing wounds is a massive unmet medical need and market opportunity. The patients, families and caregivers deserve new, curative treatment options” continued CEO Juha Yrjänheikki.
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 DFU, venous leg ulcers and pressure ulcers). In the wound AUP-16 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-16 Clinical Plan
Study AP-W-CLI-2018-8 (EudraCT number: 2018-003415-22, ClinicalTrials.gov Identifier: NCT04281992) is the first clinical study of AUP-16 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 is 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, standard-of-care controlled study of the recommended AUP-16 dose and administration schedule based on Phase 1 results to confirm safety and to assess efficacy of the selected recommended phase 2 dose and administration schedule in DFU patients.