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KDDF-201709-16 Best-in-class acid suppressant global development for GERD treatment(Gastrointestinal Diseases, Chemical) [2019-01-30]

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

Development and Market Objectives

Daewoong Pharmaceutical is developing Best-in-class antiulcerant based on the confirmed excellent acid control effect of non-clinical and clinical studies which of objection is completing phase 2 clinical trial by 2018.

Unmet Medical Need & Target Patients

Target Patients

DWP14012 is mainly for the treatment and/or maintenance therapy of gastroesophageal reflux disease, microorganism eradication therapy of H.pylori infection, and prevention of gastric ulcer. 

 

Medical Unmet Needs

Proton pump inhibitors, current 1st line treatment of acid-related diseases, require processing time and acidic environment for chemical structure changes which is essential to make an acid inhibitory effect, therefore, PPIs are normally recommended to be taken before meals. Because of short half-life of PPIs it takes about 3-5 days for sufficient efficacy. Furthermore, it has been reported that patients do not exhibit the appropriate pharmacological effect on the nocturnal acid breakthrough, which is painful. Metabolism difference by CYP2C19 possibly vary treatment efficacy of individuals (polymorphism). For these reasons, 20~30% of GERD patients and 40% of ERD (erosive reflux disease) are refractory rate of patients who have been treated by PPIs. In addition, recent H. pylori eradication rates have not reached the target rate of 80% due to the increased antibiotic resistance rate, causing prolonged antibiotic exposure in patients. Therefore, efficient acid suppression is necessary for H.pylori patients to maximize the activity of antibiotics.

Consequently, it is required to develop a new acid suppressant by overcoming the disadvantages of existing therapeutic agents. DWP14012, with new acid inhibitory mechanism of action, aims quality of life improvement of patients ultimately, based on its safe and outstanding therapeutic results.

 

Status

DWP14012 has been confirmed with potent inhibitory effect by relative studies of H+/K+-ATPase on human, pig, and dog. This program showed the high selectivity between Na+/K+-ATPase and H+/K+-ATPase. The excellent acid control effects in pylorus ligated rat, lumen perfused rat and heidenhain pouch dog model have been shown. Also, DWP14012 pharmacokinetic profile and safety margin in toxicology studies has been confirmed.

Currently, DWP14012 is under phase 2 (NCT03184324) study in GERD patients throughout 21 centers in KR. The pivotal phase 3 study to get the GERD indication will begin in 2018.

 

Also, Daewoong Pharmaceutical is operating drug-drug interaction study and phase 3 study of H.pylori eradication treatment. DWP14012 will continue development for the differentiated data through additional studies.

 

Intellectual Property

PCT applications are going to be applied in more than 50 countries comprising US, EP, JP, CN etc. Substance and other subject patents are granted.

Competitive Advantages

①  Excellent program profile

: Fast onset time over PPI, prolonged acid control effect, and compliance (once daily dose with or without food)

: Favorable tolerability and prolonged acid inhibitory effect over competitive agents

: Expansion of market share by optimization and differentiation in formulation

② Specific market penetration strategy region by region

: Maximization through professionals network, Daewoong Pharmaceutical’s global branch or co-development

: Fast globalization with KR clinical data in applicable market such as East Asia


Contact & Company Overview

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