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KDDF-201703-06 Nonclinical study of novel target inhibitor for chronic skin disorder(Immunology, Chemical) [2018-12-31]

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

Development and Market Objectives

  • The objective is to accelerate clinical development of FR-1345 for Atopic Dermatitis (AD) patients who are uncontrolled with TCS therapy. JWpharma is going to conduct a preclinical toxicity studies (GLP) and manufacture a drug product (cGMP) as well as get approval for clinical study in Korea (MFDS).

Unmet Medical Need & Target Patients

  • Unmet Medical Needs

    : AD is a common, chronic, inflammatory skin disease accompanied by intense itching and inflammation. Standard treatment modalities for the management of AD patients just consists of relieving symptoms not cure so that there are huge medical unmet needs for new drugs with novel mechanism of action for targeting both inflammation and itching (Datamonitor Healthcare’s proprietary atopic dermatitis survey, August 2015)

     

  • Target Patients

    : FR-1345, a novel small molecule inhibitor which has potent anti-pruritic and anti-inflammatory effects, is targeting moderate to severe AD patients including unctrolled AD patients to standard therapies.

Status

  • - GLP toxicity study of FR-1345

  • - Indication expansion study with animal model

  • - Process chemistry and API production of FR-1345

  • - Formulation study and DP production of FR-1345

  • - Preparation for approval of clinical phase 1 study in Korea (MFDS)

Intellectual Property

  • - A patent application for material has been filed in the PCT and three non-PCT countries, with claims for materials including FR-1345 and its derivatives

  • - 16 Countries covered by the pending patent application are in their respective implementation stages, and patent will be granted through investigations country by country.

     

  • - Application No.(Date) PCT & Non-PCT

  •    - PCT: PCT/KR2012/007965 (2012.09.28 – 2032.09.28)

  •    - Taiwan: TW101135774 (2012.09.28 – 2032.09.28)

  •    - Argentina: AR P12 01 03614 (2012.09.28 – 2032.09.28)

  •    - Venezuela: VE2013000380 (2013.04.01 – 2033.04.01)

  • - Priority No. (Date) : KR2011100369 (2011.09.30)

  • - National-phase entry

  •    - Registration : US, JP, SG, TW

  •    - Examining: KR, EP, CN, BR, IN, RU, MX, AR, VE

  •    - Pending : CA, HK

Competitive Advantages

  • - FR-1345 showed potent anti-pruritic and anti-inflammatory effects without severe toxicity compared to competitors since it has the mechanism of action that  regulates the pathophysiological causes in disease development and progression of AD

  •           

  • - FR-1345 has a novel chemical structure and safety profiles compare to competitors which showed severe adverse event such as agranulocytosis in clinical study.

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  • - Based on the preliminary toxicity and ADME data, FR-1345 has predicted to have a wide safety margin in human compared to competitors

     

Contact & Company Overview

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