Aurealis Therapeutics Developing a Drug Therapy with Multiple Active Substances in One Product Has Initiated Repeated Dosing Groups in the Diabetic Foot Ulcer Patient Trial
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.