How To Optimize CMC And Clinical Strategies For Injectable & Oral Peptide Drugs

By Dr. Andrew Lewis, Chief Scientific Officer, Quotient Sciences

The exquisite specificity/selectivity, potency, and low toxicity of peptides make them attractive drug candidates. However, their rapid clearance, poor permeability, and potential instability (e.g. in solution and physiological environments) can make them challenging to develop. But recent advances in drug discovery and peptide engineering have led to significant progress in overcoming such challenges.

When advancing into the clinic, peptide developers should anticipate the need for an exploratory first-in-human study to evaluate multiple prototypes and identify the best performing formulation, and development of a PBPK model can provide powerful insights into the critical-to-performance formulation variables.

Additionally, RapidFACT provides an adaptive CMC and clinical trial tool that lets users optimize formulations in human subjects, allowing organizations to overcome the challenges of poor correlation between preclinical models and humans. This enables data-driven decision-making that bolsters the chance of success and allows users to phase CMC investment.