PEARKO Therapeutics Inc.

Published purpose

PEARKO Therapeutics’s apelin analog will be synthesized by Bachem, a Good Manufacturing Practices (GMP)-certified producer of peptides for clinical use. We will use study findings to optimize intravenous and subcutaneous formulations of our biologic, and scale-up production. Over the same period, regulatory filings will be completed for Health Canada, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to augment the clinical trial process and international market entry. Completion of these steps will allow PEARKO Therapeutics to proceed through the final stages of preclinical development and complete the Investigational New Drug application, mandated by the FDA, in anticipation of Phase I clinical trials in 2022.