IQ Webinar: Metabolism and Excretion of Therapeutic Peptides
Metabolism and Excretion of Therapeutic Peptides: Current Industry Practices, Perspectives, and Recommendations
Presented by the Peptide ADME Working Group
Sponsored by the Translational and ADME Sciences Leadership Group
Speakers: Minxia Michelle He, Eli Lilly and Sean Xiaochun Zhu, Takeda
Moderator: Jesper Kammersgaard Christensen, Novo Nordisk
Therapeutic peptides (TPeps) have expanded from the initial endogenous peptides to complex modified peptides through medicinal chemistry efforts for almost a century. Unlike small molecules and large proteins, the diverse submodalities of TPeps have distinct structures and carry different absorption, distribution, metabolism, and excretion (ADME) properties. There is no distinct regulatory guidance for the industry on conducting ADME studies (what, how, and when) for TPeps. Therefore, the peptide ADME working group sponsored by the Translational and ADME Sciences Leadership Group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) was formed with the goal of developing a white paper focusing on metabolism and excretion studies to support discovery and development of TPeps. In this paper, the key learnings from an IQ industry survey and FDA/EMA submission documents of TPeps approved between 2011 and 2022 are outlined in detail. In addition, a comprehensive assessment of in vitro and vivo metabolism and excretion studies, mitigation strategies for TPep metabolism, analytical tools to conduct studies, regulatory status, and Metabolites in Safety Testing (MIST) consideration are provided. Finally, an industry recommendation on conducting metabolism and excretion studies is proposed for regulatory filing of TPeps.
This is a public webinar. Membership in IQ Consortium is not required.