vicore pharma ab€¦ · vicore pharma ab webcast – cta for the treatment of covid -19 with c21,...
TRANSCRIPT
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VICORE PHARMA AB
Webcast – CTA for the treatment of COVID-19 with C21, March 2020
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C21 IN COVID-19
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COVID-19 is an emerging pandemic for which we have no cure
COVID-19Started in China December 2019Now spread to 199 countries800,000 confirmed infectedMore contagious than common flu and SARSMortality rate estimated to 2%38,000 Deaths
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C21 IN COVID-19
RAS in COVID-19 - Background
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C21 IN COVID-19 - RENIN-ANGIOTENSIN SYSTEM (RAS)
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There is a balance between pro-inflammatory AT1R and anti-inflammatory AT2R
C21
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C21 IN COVID-19 - THE CoV-2 CREATES AN IMBALANCE IN RAS
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C21, an AT2R agonist, may bypass the RAS imbalance to prevent the cytokine storm
The virus hi-jacks ACE2 forcellular entry and triggersan imbalance in RAS leading to acytokine storm in the lungs (ARDS)
Direct stimulation of AT2R may bypassthe incapacitated ACE2 to counteract
the inflammatory drive
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C21 IN COVID-19 - MODE OF ACTION
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Angiotensin II has2 receptors withopposite actions
AT1R AT2R
ANG II
VASOCONSTRICTIONINFLAMMATION
FIBROSIS
VASODILATIONANTI-INFLAMMATION
ANTI-FIBROSIS
In COVID 19, ACE2 is hi-jacked resulting in
increased AT1R activation
It is hoped that, by stimulatingAT2R directly, C21 will
counteract the ANG II effects
C21 may bypass ACE2 and be directly anti-inflammatory through AT2R
C21 is a first in class small molecule stimulating the angiotensin type 2 receptor (AT2R)
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C21 IN COVID-19
Phase II PoC study
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C21 IN COVID-19 - SELECTION OF PATIENT POPULATION
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Mild diseaseHome care
Moderate diseaseHospital care
Severe diseaseMechanical ventilation
Oxygen support
Progress
RecoveryRecovery
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C21 IN COVID-19 - STUDY DESIGN
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A randomized, double-blind, placebo-controlled phase II trial investigating the efficacy of C21 on oxygen saturation and outcome in
subjects with moderate COVID-19 treated with oxygen supply
• Patients will be monitored for oxygen saturation, which determines outcome –recovery or disease progression with need for assisted ventilation
• The study will also measure infection parameters and biomarkers
• We will initially have one site and anticipate to start in approximately 4 weeks with completion of the clinical part in 3 months
The primary endpoint is to prevent disease progression
RandomizationScreen FU
1 week
C21 100 mg BID n=25
Placebo n=25
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C21 IN COVID19
Summary
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C21 IN COVID-19 – SUMMARY
• The COVID-19 is an emerging pandemic for which there is currently no cure
• The virus hi-jacks the enzyme ACE2 to infect the alveolar cells
• ACE2 normally brakes down pro-inflammatory ANGII to molecules that are protective via AT2R
• Binding of virus incapacitates ACE2 leading to an imbalance in the RAS system, promoting inflammation and development of ARDS
• C21, an AT2R agonist, is independent of ACE2 and may therefore prevent the lung damaging inflammation in COVID-19
• The company has generated preclinical data to support the concept
• A rolling CTA submission has been initiated today and Vicoreanticipates to start enrolling patients in 4 weeks
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