Report on Project KDDF-201402-01: A Novel TCTP-PTD-Based Intranasal Insulin Delivery Platform

Executive Summary

This report provides a comprehensive analysis of the research and development initiative identified by the project code KDDF-201402-01. It must be clarified at the outset that KDDF-201402-01 is not the name of a medication but rather a grant identifier for a project funded by the Korea Drug Development Fund (KDDF). The project, conducted primarily at Ewha Womans University, focuses on a highly innovative and potentially disruptive technology for the non-invasive, intranasal delivery of insulin.

The core of this technology is a novel cell-penetrating peptide (CPP), specifically a Protein Transduction Domain (PTD) derived from the N-terminus of the human Translationally Controlled Tumor Protein (TCTP-PTD). This platform was developed to overcome the significant physiological barriers that have historically limited the efficacy of intranasal macromolecule delivery. Preclinical studies have demonstrated exceptional performance, achieving a relative bioavailability for insulin as high as 60.71% compared to standard subcutaneous injection. This figure stands in stark contrast to the low single-digit bioavailability of unassisted intranasal insulin and represents a potential paradigm shift in the field.

A foundational element of the platform's strategic design is the use of a human-derived peptide, which preclinical toxicological assessments have validated. Studies show a complete lack of detectable local or systemic toxicity, a critical advantage over viral-derived peptides or chemical permeation enhancers. The research program has demonstrated a high degree of sophistication, progressing from initial proof-of-concept to the rational design of optimized peptide analogs and the development of advanced formulations to maximize efficacy and stability.