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KDDF-201512-03 Pre-clinical study & clinical IND approval for the development of anti-allergic asthma drug(Respiratory Diseases, Natural) [04.15.2016]

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Development and Market Objectives

DW2008 is a natural product that inhibits both allergic inflammation and bronchoconstriction, and is currently under nonclinical GLP study for developing anti-allergic asthma drug. We plan to test on the toxicity and additional efficacy of DW2008 for global licensing-out, as well as for local launching.

Unmet Medical Need & Target Patients

A. Target population
1) Asthmatic patients who are ranked at step2(Mild) ~ step5(Severe) of GINA guideline.
2) Asthmatic patients, especially old age patients and pediatric patients, who show poor medication compliance in inhalation therapy.
3) Asthmatic patients who are not improved with leukotriene receptor antagonists.

4) Asthmatic patients who show steroid resistance.

 

B. Un-met Needs
1) 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. 
2) 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.
3) 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. 
4) Whereas there are inhaler combination drugs “ICS+LARB”, there are no oral drugs with anti-allergic inflammatory effects and bronchodilation effects.

Status

A. The candidate DW2008 is currently under GLP preclinical study according to OECD, ICH guideline in Korea
B. The candidate DW2008 is currently under drug positioning study in 5 asthma subtype animal models and searching specific biomarkers for setting up optimal patient selection criteria.

Intellectual Property

- Patent pending: Korea (2) PCT(1)
- Covering worldwide
 

Competitive Advantages

A. Efficacy & MoA
1) Both anti-allergic inflammatory effect and bronchodilation effect
2) Superior effect comparing Montelukast(allergy inflammation) and Ambroxol(Mucosal Secretion)
3) Th2/Th17 selectivity
4) Finding several targets relating to anti-allergic inflammation and bronchodilation

 

B. CMC
1) Well-controlled CMC
2) Using GAP(Good agriculture practice) certificated botanical material
3) Identification of over 80% components (in HPLC peak area)

 

C. Compliance and Others
1) better medical compliance than inhalation
2) Beyond indications to other allergic diseases or respiratory diseases, such as rhinitis, atopic dermatitis, and COPD.

Indication

Asthma

Research Period

Apr. 1, 2016 ~ Mar. 31, 2018

Company

DONGWHA PHARM. Co., Ltd.

Developmental Stage

Preclinical

Additional Information

Contact Information

Contact
Address Company Name: DONGWHA PHARM. Co., Ltd.
WebSite Homepage: http://www.dong-wha.co.kr Contact Person: Joobyoung Yoon
E-mail: joobyoung.yoon@dong-wha.co.kr Contact: +82-31-270-0735

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