The world’s first Endothelial Dysfunction Blocker, ED Blocker [ First-in-Class ]

  • A blood vessel leakage inhibitor with a completely new mechanism → Demonstrates excellent synergistic effect against various blood vessel-related diseases and as a concomitant medication with existing anticancer medicine.

Candidate substance

Type of MoleculeSmall molecule
MechanismVascular leakage blocker by Solvadys™ Technology
SpecialtyFirst-in-class, oral therapy

Indications

Retinal disease : Diabetic macular edema, macular degeneration
Lung disease : Acute respiratory distress syndrome
Brain disease : Stroke
Heart disease : Myocardial infarction, Unstable angina
Cancer : Monotherapy and/or combination with other existing drugs
Inflammatory bowel disease : Ulcerative colitis, Crohn’s disease
Other edema-related diseases : Acute respiratory distress syndrome, Hereditary angioedema

Development progress

  • 1.Demonstrate the excellent efficacy in various vascular disease preclinical models
  • 2.Prove the synergic effect with the existing anticancer drug in cancer model by combination therapy
  • 3.Confirm the safety margin (>30 fold) based on GLP toxicology studies (Completed)
  • 4.Investigational New Drug (IND) Approval from FDA for Phase 1 Study.
    Further details on the Phase 1 trial can be found at https://clinicaltrials.gov, NCT number: NCT04795037
  • 5.Secure intellectual property rights
    : Patent( Registrated : Korea, USA, Europe, Japan, China Applied : PCT)
    : Method Patent ( Registrated: Korea, Applied : USA, Eeurope, three countries incl. PCT)
    : Polymorphism Patent : ( Registrated: Korea, Applied: USA, Europe, 10 countries incl. PCT)

Mechanism of action

  • Enhanced survival rate of vascular endothelial cells and fundamentally blocked endothelial cell dysfunction through structural modification of actin.
  • Stabilizes EC junction and strongly block vascular leakage through cAMP/cortactin pathway

Major features of CU06 and comparisons with anti-VEGF therapy

Comparisons with CU06 and anti-VEGF therapy
: Differentiating from existing treatments by affecting various factors that cause disease

CU06 Anti-VEGF therapy
Modality Small molecule Biologics
Administration Route Oral Injection
Inhibition of hyperpermeable factors Inhibits all hyperpermeable factors including VEGF, IL-1b, MCP-1, histamine, and thrombin Inhibits only VEGF
Indications Various diseases related to vascular damage Associated diseases caused by VEGF

Diabetic macular edema/Retinopathy [ First-in-Class ]
CU06-EYE effectively treats retinal disease by directly restoring retinal vascular leakage and dysfunction caused by various factors

Diabetic macular edema/Retinopathy
CU06-EYE can be equally applied to other retinal diseases, including AMD
Diabetic macular edema is a disease in which liquid penetrates the macula, the light-sensing layer, causing the macula to swell.
Diabetic retinopathy is one of the microvascular complications for people with diabetes, damaging the retinal vessel.
Diabetic retinopathy may lead to blindness if left untreated : The disease may be caused by the activation of various biomolecules, including EGF and AGE.
Medicine of an entirely new concept beyond limitations of existing anti-inflammation or VEGF block therapy is required

Existing medicine and unmet medical needs

Global market perspective

Acute Respiratory Distress Syndrome(ARDS) [ First-in-Class ]
CU06-ARDS is an innovative concept treatment that prevents damage, inflammation, and edema of lung by preventing damage/leakage of blood vessels induced by pathogen related sepsis.

Acute Respiratory Distress Syndrome(ARDS)
Sepsis-induced ARDS is correlated with high morbidity and mortality after lung infection within several days.
Excessive host immune responses to infection leads to disruption of the pulmonary alveolar-capillary barrier, followed by hypoxemia, inflammation, and noncardiogenic pulmonary edema.
No pharmacological therapies are developed except conservative treatment such as infection control and nutrition therapy.
High unmet medical needs due to limitations of existing multiple organ failure resulting in bad quality of life.

Existing medicine and unmet medical needs

Global market perspective

Acute MI [ First-in-Class ]
CU06-MI is an innovative concept treatment that prevents damage, inflammation, and edema of cardiac tissue by preventing damage/leakage of blood vessels followed by reperfusion of occluded blood vessels.

Myocardial infarction
Myocardial Infarction Type 1
Cardiovascular diseases (CVD), including ischemic heart disease and stroke, are the leading causes of mortality in the world.
Coronary artery occlusion (stenosis) results in ischemia (a reduction or loss of blood flow to tissue) and the necrosis of myocardial tissue by vascular leakage.
Myocardial Infarction Type 2
Prominent wave of sales increase comes from PCSK9 inhibitor class, which is expected to reach 2.5 billion in global sales by 2025.
High unmet medical needs for the therapies of both acute MI & chronic MI associated with the cardiac dysfunction.

Existing medicine and unmet medical needs

Global market perspective

Inflammatory bowel disease treatment [ First-in-Class ]
CU06-IBD is the first treatment to demonstrate the possibility of curing inflammatory bowel disease with a differentiated mechanism of action based on intestinal vascular stabilization, anti-vascular inflammation, and sulfation activity.

Inflammatory bowel disease treatment
Abnormal chronic inflammation of the digestive tract
A new concept for treatment that cures Intestinal inflammation is needed
Crohn’s disease (sporadically occurs in the small and large intestine) and ulcerative colitis (occurs in the mucous membrane or submucous layer of the large intestine)
Symptoms : Diluted stool with blood and mucus, diarrhea, abdominal pain, dehydration, etc.

Existing medicine and unmet medical needs

Global market perspective