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KDDF-201812-08 Development of first-in-class topical drug for atopic dermatitis using FPR2-selective peptide ligand(Immunology, Protein) [2019-08-29]

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Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

• We aim to develop a first-in-class topical peptide immunotherapy against atopic dermatitis by targeting FPR2

• The objectives of the program are to submit IND application by securing the profiles of safety, stability, manufacturing process, and efficacy.

Unmet Medical Need & Target Patients

• Target Patients
Mild-to-moderate atopic dermatitis patients

 

• Unmet medical needs

  - Need to develop new drugs dealing with key aspects of atopic dermatitis; skin barrier damage, immunological dysfunction, and pruritus

  - Increased demand for new topical agents due to safety concern of non-specific immunosuppressants such as steroids

  - Need to secure safety, cost efficiency, and patient-convenience (non-invasive) considering long-term administration and pediatric use

Status

• Underway 
  - In-depth studies for MoA and efficacy of FPR2-specific peptide ligand 
  - Manufacturing process development of API and studies for CMC 
  - Development of drug product containing peptide and studies for CMC


• Planned
  - Non-clinical GLP toxicity studies in CRO
  - ADME studies of the peptide API
 

Intellectual Property

• A domestic patent including the substances and use for atopic dermatitis was registered.
• PCT for international markets has been filed and patents for five countries (US, EU, JP, CN, HK) are under National Phase Entry.
• A follow-up patent for new peptides has been filed for by expanding patent rights.
 

Competitive Advantages

• Novel target 
  - Novel strategy targeting FPR2 to induce pro-resolving function.
  - First-in-class topical immunotherapy that can control complex factors including skin inflammation, skin barrier disruption, and pruritus.


• Safety (long-term use)
  - High biocompatibility of peptide material and low systemic effects of topical treatment.
  - Safe topical agents replacing steroid drugs for long-term use in mild-to-moderate patients, especially for pediatric patients.


• Patient-convenient and cost-effective
  - Topical agent providing convenient administration for pediatric patients.
  - Chemically synthesizable small size peptide which can secure cost efficiency than expensive biologics drug.

Contact & Company Overview

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