Abstract

Formulation Strategies for a Biologic to Treat Chronic Wounds

Manfred Schuster, CEO, ReMute-Bio GmbH

Our recently founded company overtook and reset the development program of the pharmacologically highly potent biologic Stathmin. Its cellular and immunological wound healing mechanisms initially were explored in an unfortunate clinical development program, which needed to be discontinued due to safety and tolerability issues. We identified and overcame this and several additional mistakes of the initial drug product, and have already started to investigate its therapeutic potential in an optimized topical formulation to eventually treat chronic, not healing wounds like venous or diabetic ulcers. This talk will depict the most important aspects we needed to address to develop a safe and tolerable ultra-slow release formulation, which stabilizes the active compound also when exposed to a plethora of proteolytic enzymes present in infected wounds.