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KDDF-201803-06 Clinical Phase I study & Clinical Phase II IND approval of DW2008S anti-allergic asthma agent(Respiratory Diseases, Natural) [2019-06-24]

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

Development and Market Objectives

DW2008 is a natural product that inhibits both allergic inflammation and bronchoconstriction, and is currently under Clinical phase I study (SAD & MAD) for obtaining the information on safety and tolerability of DW2008S in healthy volunteers. We additionally plan to test on the toxicity and efficacy of DW2008 for global licensing-out, as well as for local launching.

Unmet Medical Need & Target Patients

Target population

- Asthmatic patients who are ranked at step2(Mild) ~ step5(Severe) of GINA guideline.

- Asthmatic patients, especially old age patients and pediatric patients, who show poor medication compliance in inhalation therapy.

- Asthmatic patients who are not improved with leukotriene receptor antagonists.

- Asthmatic patients who show steroid resistance.

 

Un-met Needs

- Inhalation Corticosteroids(ICS) are current 1’st line therapeutic drugs of asthma, which exert good anti-inflammatory activities. But, ICS also show lots of regional adverse effects, steroid phobia, poor medication compliance.

- Bronchodilators temporarily relieve asthmatic symptoms as relievers. But, they rather have risk for an asthma exacerbation in case of long term treatment, because they have not anti-inflammatory activities. They are also inhalers that cause poor medication compliance.

- Leukotrine receptor antagonists(LTRA) are oral asthmatic drugs with over 90% market share, and have good medication compliance. But, they are usually used as add-on therapy to ICS, due to their insufficient efficacy. Whereas there are inhaler combination drugs “ICS+LARB”, there are no oral drugs with anti-allergic inflammatory effects and bronchodilation effects.

Status

- The candidate DW2008S is currently under clinical phase I (SAD & MAD) study in Korea

- Evaluation of efficacies in steroid-resistant asthmatic model of mice

- CMC study

- DDI (Enzyme Induction) study

- Repeated-dose toxicity study in Non-rodents (26 weeks)

Intellectual Property

- Patent registration: Korea (1)

- Patent pending: Korea (1), 15 countries (1)

- Covering worldwide

Competitive Advantages

Efficacy & MoA

- Dual effects (anti-allergic inflammatory effect and bronchodilation effect)

- Superior effects of DW2008 versus Montelukast(allergy inflammation)

- Th2 selectivity

- Identification of 3 targets relating to anti-allergic inflammation and bronchodilation

 

CMC

- Well-controlled CMC

- Using GAP(Good agriculture practice) certificated botanical material

- Identification of over 90% components (in HPLC peak area)

 

Compliance and Others

- Better medical compliance than inhalation

- Beyond indications to other allergic diseases or respiratory diseases, such as rhinitis, atopic dermatitis, and COPD.

Contact & Company Overview

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