Pipeline

CU103

CU103

Expanded indication of CU06 for Stroke

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CU103 Expanded indication of CU06 for Stroke
Indication Stroke
Unmet Needs

• A leading cause of death and disability globally, particularly in low-income and middle-income countries, and this burden is increasing.

• Estimated prevalence of unmet needs was 59.7% to 83.7% for body functioning, and 48.4% for activities/participation. (source: BMJ 2019)

• Urgent need to develop effective neuroprotective agents for the prevention and treatment of cerebral ischemia

Mechanism of Action

• Preserves BBB integrity by stabilizing the EC junction and reduces astrocyte end-feet swelling following I/R.

• CU103 attenuates inflammation responses by inhibiting NF-κB activation

• CU103 protects the brain from I/R injury by preventing BBB disruption and inflammation

Efficacy & Safety

• Reduction of infarction volume and edema in a cerebral I/R mouse model

• Inhibition of astrocyte end-feet swelling and activation after I/R

• Prevention of disruption of basal membrane proteins in endothelial cells after I/R

• Decrease in of cerebral injury after I/R in rat model

Market

• 5.1 billion US$ in 2021 (8 Major Markets) for Acute Ischemic Stroke

• Forecasted to be 7.3 billion US$ in 2027 (8 Major Markets) for Acute Ischemic Stroke

Indication

Cause

  • The blood supply to a part of the brain is suddenly reduced, which prevents the brain from getting oxygen and other nutrients from the blood.
    - Ischemic stroke (80% of total stroke): blocked artery due to blood clot
    - Hemorrhagic stroke (20% of total stroke): leakage or rupture of arteries

Incidence, Mortality

  • Incidence: More than 795,000 people in the US every year
  • Mortality: Every 4 minutes, someone dies of a stroke in the US

Symptoms

  • - Confusion, including difficulty speaking and understanding speech
  • - Headache, possibly with altered consciousness or vomiting
  • - Numbness or an inability to move parts of the face, arm, or leg, particularly on one side of the body
  • - Vision problems in one or both eyes
  • - Difficulty in walking, including dizziness and a lack of coordination

Unmet Needs

  • A leading cause of death and disability globally, particularly in low-income and middle-income countries, and this burden is increasing
  • Estimated prevalence of unmet needs was 59.7% to 83.7% for body functioning, and 48.4% for activities/participation. (source: BMJ 2019)
  • Urgent need to develop effective neuroprotective agents for the prevention and treatment of cerebral ischemia

Mechanism of Action

  • Preservers BBB integrity by stabilizing the EC structure junction and reduces astrocyte end-feet swelling following I/R.
  • CU103 attenuates inflammation responses through inhibiting NF-κB activation
  • CU103 Protects the brain from I/R injury by preventing BBB disruption and inflammation

The CU103, EC dysfunction blocker has neuro-protective activities by maintaining BBB integrity, demonstrates a promising drug for stroke

Efficacy

Reduction of infarction volume and edema in cerebral I/R mouse model

CU103 attenuates infarction region in MCAO mouse model

I/R: Ischemia-Reperfusion
MCAO: Middle Cerebral Artery Occlusion

Inhibition of astrocyte end-feet swelling and activation after I/R

CU103 likely alleviates astrocyte end-feet destruction by stabilizing the vascular structure after I/R

Prevention of disruption of basal membrane proteins in endothelial cells after I/R

CU103 recovers β1-integrin & β-DG expression

Decrease in cerebral injury after I/R in rat model

Similar effect confirmed in the rat (larger animal) model and mouse model