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KDDF-201404-10 Global Development of CJ-12420, the next generation acid suppressant(Gastrointestinal Diseases, Chemical) [08.05.2014]

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Development and Market Objectives

CJ-12420 belongs to a new class of acid secretion inhibitors called potassium-competitive acid blockers (P-CAB). Based on the outstanding pharmacology results of pre-clinical and phase 1 clinical studies, we would like to maximize the licensing value of CJ-12420 by executing preclinical and clinical studies for differentiated efficacy and long-term safety. CJ-12420, the next generation acid suppressant, is expected to be a global blockbuster drug with clinical development in the world's key "pharmerging" markets including China.

Unmet Medical Need & Target Patients

Target Patient Population:

Target patients of CJ-12420 are people with acid related diseases such as peptic ulcer, gastroesophageal reflux disease, and H.pylori infection.

 

Unmet Medical Needs:

Acid-related diseases means various digestive disorders associated with gastric acid including gastric ulcer, duodenal ulcer, erosive esophagitis, and non-erosive  reflux disease, etc. Acid related diseases can be cured, or at least the symptoms can be alleviated significantly by inhibiting gastric acid secretion.

It has been reported that these diseases are increasing due to aging, obesity, alcohol, and caffeine. We expect more than 250 million patients to exist in the global pharmaceutical market by 2020. Thereare more than $ 30 billion prescription drugs for gastrointestinal disorders by 2020, which is the largest market in the entire drug treatment industry.

 

Especially, gastroesophageal reflux disease(GERD) is a disease type in developed countries and its incidence in the developed world is very high at about 20%. Due to the increasingly growing factors such as aging, obesity, mental stress, GERD incidence is continuously rising. GERD is the conditions of discomfort or complications due to the stomach contents reflux or back up into the esophagus. It is classified into erosive esophagitis (EE) and non-erosive reflux disease (NERD), and may cause severe complications. Heartburn and acid reflux symptoms are typical symptoms. GERD is a chronic condition in most cases, and its recurrence rate is very high.

 

Acid suppressants have been the biggest-selling drugs worldwide since the release of H2 receptor antagonists in 1970s and introduction of proton pump inhibitors in late 1980s. Proton pump inhibitor(PPI) currently holds the major part of acid suppressant market, but has identifiable limitations related to its mode of action; it requires several days to achieve maximum suppression, is less efficacious when administered post-prandially, and has large individual differences. The purpose of this study is to develop CJ-12420, the next generation acid suppressant as a global blockbuster drug that overcomes the limitations addressed by currently available PPI.

Status

CJ-12420 showed potent inhibitory effect on H+/K+-ATPase from human, pig, and dog. We also confirm the high selectivity between Na+/K+-ATPase and H+/K+-ATPase.

 

CJ-12420 totally suppressed acid secretion in Heidenhain pouch (HP) dog compared to 80% inhibition of Revaprazan at 3mg/kg. Phase 1 results showed dose dependent acid suppression, potent efficacy and fast onset time. CJ-12420 is currently undergoing Phase III clinical trials after successfully concluding phase 2 clinical trials in Korea last year. Compared to existing antiulcer drugs, CJ-12420 has been shown to relieve symptoms more quickly with prolonged effects in clinical trials.

Intellectual Property

Patents on substance and other subject matters are granted in the major countries including Korea, China, Honkong, and the United States.

Competitive Advantages

PPIs, current mainstay of acid related disease, are acid-activated pro-drugs that require consumption of food for stimulation of proton pumps because they only bind to active proton pumps. CJ-12420, on the other hand, binds to both resting and stimulated pumps, which exerts potent efficacy under any gastric conditions. 

 

Pharmacology
Inhibition of both resting and activated gastric H+/K+-ATPase 
Highly selective inhibition of gastric H+/K+-ATPase

 

Pharmacokinetics and Drug Metabolism
Rapid absorption 
Low risk for drug-drug interaction

 

Safety
Safe and well tolerated in various clinical studies including 300 patients 
No clinically significant liver toxicity reported

 

Pharmacokinetics/Pharmacodynamics
Rapid absorption within 0.5 to 1.5 hour
Rapidly increased median pH>4

Complete control of NAB upon administration before bed
Remarkably similar acid suppression profile in both fed and fasting state

 

We are planning to conduct preclinical and clinical studies for demonstrating distinctive efficacay/safety data in parallel with our own domestic phase 3 trial. Via those study results, we are expecting to enhance licensing value and to establish stable business foundation for global market entry. The important thing for licensee would be not only differentiated pharmacology and development risk but also domestic market entry of drug. Quicker market entry can make them achieve profit more. Therefore, the fast launch to their market make the drug very attractive and increase licensing value. We are also striving   to maximize the licensing value through preemptive execution of long-term toxicity studies, and initiation of clinical development in China. 
 

Indication

Gastrointestinal Disease

Research Period

2014.7.1-2017.7.31

Company

CJ HealthCare

Developmental Stage

Additional Information

Preclinical

Contact Information

Contact
Address Company Name: CJ HealthCare
WebSite Homepage: http://www.cjp.co.kr/indexEn.asp Contact Person: Park, Byung Chul
E-mail: bcpark77@cj.net Contact: +82-31-639-4317

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