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The Regio Solution:

Medical therapy to directly reduce plaque burden and reverse disease by accelerating the process of cholesterol removal

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Complement and synergize with current standard of care that is focused on LDL lowering by enhancing the natural process of reverse cholesterol transport

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Provide a patient-centric solution (once-monthly injection)

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A clear pathway to approval and commercialization for PAD indication and the more extensive CAD-MACE outcome trial

Only Half of the Picture

Existing Medicines Treat Atherosclerosis by Removing LDL from Circulation & Slowing Plaque Growth

Statins

Inhibit the production of cholesterol in the liver and may reduce vascular inflammation.

LDL-R

PCSK9 inhibitors

Promote expression of the LDL-R in the liver to increase removal of highly atherogenic lipids from the serum

The Other Half of the Picture

Removing Cholesterol-Rich Plaques via Reverse Cholesterol Transport (RCT)

Atherosclerosis  with cholesterol-rich plaques is the main cause of PAD and CAD

Regio Biosciences
Coronary Artery Disease (CAD)
Restricted Blood Flow
Cholesterol Plaques
Peripheral Artery Disease
Improved Blood Flow
Removal of cholesterol via reverse cholesterol transport

REG-101 is leading the way

Reverse cholesterol transport is the process of lipid removal from peripheral organs such as blood vessels.

Forward cholesterol transport (FCT) Equilibrium Reverse cholesterol transport (RCT)

Without treatment, LDL deposits cholesterol in the arteries, increasing atherosclerosis

Statins and PCSK9 inhibitors are focused on lowering lipids to slow down FCT

REG-101 would be the first therapy to increase reverse cholesterol transport, complementing the LDL receptor upregulation of statins

HDL removes cholesterol from peripheral tissues, reversing atherosclerosis

The goal is to shift the equilibrium towards RCT, removing cholesterol from plaques and thus improving blood flow to vital organs

(EL / LIPG)

REG-101 Increases RCT by Blocking Endothelial Lipase (EL / LIPG)

  • Endothelial Lipase (EL) is a major phospholipase and the rate limiting step for HDL catabolism
  • EL disrupts normal lipid homeostasis
  • Elevated EL in macrophages leads to formation of foam cells and activation of inflammatory macrophages
EL LIPG Regio Biosciences Image

EL is elevated under inflammatory states and following CV events, such as myocardial infarction

Neutralization of EL by REG-101 promotes HDL functionality and enhances cholesterol efflux from plaques

Plaque regression and stabilization in vulnerable vascular beds (coronary, carotid, cerebral) and reduction of cardiovascular events

REG-101 is a humanized and affinity matured mAb IgG4P Kappa originally generated by mouse hybridoma technology and displays high specificity for EL.

Whole Process Support

REG-101 Supports the Whole Process of Reverse Cholesterol Transport

By Blocking EL, REG101 Stimulates Multiple Steps in Cholesterol (CHL) Removal

  • Promotes delivery of CHL substrate to the liver for further clearance through bile, enhancing the actions of statins and PCSK9 inhibitors
  • Prevents HDL loss via kidney filtration
  • Increases plasma HDL particle numbers and improves HDL functionality
  • Enhances efflux of cholesterol from macrophages
REG-101 Supports the whole Process Image

Summary

Highly Targeted EL Antagonistic Antibody, REG-001 Enhances LDL Efflux From Plaques to Reduce Atherosclerosis

REG-101 Enhances RCT

Regio Pipeline

Committed to Developing Targeting Medicines For Addressing Atherosclerosis

Regio Bio REG-101 Pipeline
  • REG-101 has proof of mechanism clinical data in coronary artery disease (CAD)
  • Regio is also pursuing REG-101 for peripheral vascular disease (PAD) based on differentiated MOA through RCT and a faster pathway to market