Accelerated Peptide Drug Development & Clinical Strategies: An Integrated Program Case Study With Endevica Bio

A start-up biotech was developing TCMCB07 as a novel synthetic peptide product for the potential treatment of cachexia. Cachexia is a life-threatening aspect of many late-stage diseases, such as cancer, which results in weight loss. TCMCB07 is a first-in-class MC4R antagonist synthetic peptide that has been shown to reverse cachexia in rodents and dogs.

The drug itself posed several challenges, as it is a potent synthetic peptide with high acetate ion content, pH-dependent solubility, and compatibility risks with certain plastics, which resulted in subsequent filtration challenges for the formulation. Quotient Sciences’ Translational Pharmaceutics® platform, which integrates formulation development with real-time manufacturing and clinical testing in a single program, helped facilitate the production of multiple formulations that could be taken into the clinical study to maximize the chance of success in finding the required dose.

Review how an integrated approach and innovative filtration strategies helped bring this novel therapeutic to Phase 1 clinical trials with reduced time and costs.