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KDDF-201210-07 Development of an Anti-myocardial Infarction Agent against Ischemia-Reperfusion Injury with A Novel Necrosis Inhibitor, LC28-0126(Cardiovascular Diseases, Chemical) [01.17.2013]

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Development and Market Objectives

- Development of a cardio-protective agent through successful completion of clinical Phases 1 & 2 using a novel class of necrosis inhibitor, LC28-0126 (CYCL001 Ver. 1.0 approved by MFDS) by demonstrating safety & tolerability in Phase 1 as well as its suppressive effect on infarct size against lethal ischemia-reperfusion (IR) injury during percutaneous coronary intervention (PCI) for the ST-segment elevation with myocardial infarction (STEMI) patients with acute myocardial infarction (AMI) in Phase 2.

Unmet Medical Need & Target Patients

Target Patients

- The STEMI patients with AMI were selected as the primary target to clearly demonstrate the efficacy of LC28-0126 in Phase 2.
- The non-STEMI patients will be tested after completion of Phase 2 in STEMI patients. 

Unmet Medical Needs

- More than 1,000,000 cases of myocardial infarction (MI) occur in the US every year and the high prevalence rate of 600 cases/100,000 population was reported. However, no drugs are currently available to effectively treat this condition.
- The patients with AMI without PCI settings typically exhibit 70% of infarcted area, causing death from heart attack.
- The PCI administration for the patients with AMI ultimately could extend their life, but paradoxically, > 30% of the infarcted area still remains due to lethal reperfusion injury caused by excess blood and oxygen provided at the time of the procedure.

Consequently, 5 ~ 10% of the patients with PCI setting die within a year, or the patients should endure significant medical expenses due to serious clinical complications in their lives.
- All drugs that were successfully developed in preclinical stage failed in the clinical trials performed for the patients with MI as they did not demonstrate fundamental reductions in size of the myocardial infarct. The underlying reason is due to the fact that the size of infarct is decisively influenced by the degree of necrosis of myocardial cells.
- Therefore, there exist significant unmet medical needs in the development of a treatment drug which can reduce the infarct area of 30% post PCI, down to < 5%. LC28-0126 a strong novel necrosis inhibitor that specifically targets the mitochondria was developed by LG Life Sciences. This is the first time in the world LC28-0126 a novel necrosis inhibitor to be tested in the clinical trial for AMI patients, suggesting its clinical implications in the area of ACS (Acute Coronary Syndrome) for which there are no adequate treatments.

Status

- A clinical Phase 1 trial with healthy volunteers was completed in 4Q, 2014, Korea. The clinical Phase 2a for AMI with 60 STEMI patients has been completed in 4Q, 2015. Additional clinical Phase 2a for 100 STEMI patients approved by KFDA (2015) has been initiated in April, 2016.
- A backup study of chemical synthesis is also underway.
- Out-licensing or collaborative research opportunities including the “LGLS-Necrosis Program” are available.
- Partnership for the clinical studies for MI is possible.

Intellectual Property

- 3 material patents and several use patents covered worldwide.

Competitive Advantages

- Thus far, anti-platelet agents have been used as secondary drugs to vasodilatation in PCI procedure. Three clinical candidates of MI inhibitors have been tried to demonstrate efficacy for reduction in the infarct size for STEMI patients in clinical trials: cyclosporine A, Phase 3; Bendavia & TRO-40303, Phase 2. However, all of these candidates have recently failed in the clinical trials for AMI with STEMI patients, which might be mainly due to the action mechanism of these apoptosis inhibitors that could not fundamentally block myocardial necrosis. 

- Drugs that can effectively reduce the size of myocardial infarct against lethal IR injury during PCI administration do not yet exist. Therefore, there exist significant medical unmet needs in the development of drugs, that is, strong necrosis inhibitors that can fundamentally block myocardial cell necrosis, the main cell-death mechanism of myocardial infarction.

- Therefore, LGLS LC28-0126 showing inhibitory effects on cellular necrosis and (2) strong efficacy of reduction in infarct size in the rat MI model is expected to potentially demonstrate the fundamental reduction in infarct size against lethal reperfusion injury in the clinical settings.

Indication

Myocardial infarction

Research Period

2012.12.1-2018.8.31

Company

LG Chem

Developmental Stage

PhaseⅠ

Additional Information

Contact Information

Contact
Address Company Name: LG Life Sciences
WebSite Homepage: http://lgls.com Contact Person: Soon-Ha Kim
E-mail: shakim@lgls.com Contact: +82-42-866-4925

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