Investors
Despite the inadequacy of the current standard of care, the lipid management market is growing very strongly, and analyses suggest the market will reach nearly $70 billion per year by 2030.
Even with the introduction of generic disease management drugs over the last several years, we believe the opportunity for a true preventative drug is significant as global costs associated with CVD are projected to exceed $1 trillion by 2035.
To date, all of the drugs on the market are either protective or preventative, but none are both protective and preventative, and none are disease modifying.
Cholesterol and Triglyceride Mediation Market (current non-disease modifying drugs)
Drug Class
Indication
- Hypercholesterolemia
- Coronary Artery Disease
- Higher Triglycerides
A recent Swedish study suggested that as many as 42% of adults over 40 years old who have no history or diagnosis of any cardiovascular disease are still carrying a significant and measurable atherosclerosis load. The opportunity to prevent future pathologies is significant, as is the possibility of reducing and preventing numerous co-morbidities associated with atherosclerosis.
42%
Adults without heart disease that have measurable plaque load
Beyond CVD, the oxidized cholesterol that is our prime target for atherosclerosis, 7-ketocholesterol (7KC), is also heavily implicated in Alzheimer’s disease and forms of kidney and liver disease. This will offer a host of repurposing for 7KC removal even before introducing new molecular targets. It also allows us to maintain an overall longevity focus.
Furthermore, we are also exploring an interest in the role of oxidized cholesterol in impeding stroke recovery and causing inflammation that impedes stroke recovery. Stroke is currently responsible for one in ten deaths world-wide.
The Growing Cost of CVD
| CVD annual costs (US) | Current | 2035 |
|---|---|---|
| Medical costs up 135% | $318 billion | $749 billion |
| Indirect costs up 55% (Lost productivity) | $237billion | $368 billion |
| TOTAL COSTS | $555 billion | $1.1 trillion |
“By 2035, across all conditions, total CVD costs will more than triple among those age 80+ and more than double among those age 65-79.”
Current treatments are not only ineffective in reversing cardiovascular disease, but the current irreversibility of accumulated morbidities combined with an ever-aging population has the US population on a trajectory to exceed $1 trillion per year in direct and indirect costs related to CVD.
Our Lead Product: UDP-003
UDP-003 is a first-in-class drug; a specially engineered and physically synthesized cyclodextrin which will target and remove toxic oxidized cholesterol, a key driver of atherosclerosis, neurodegenerative diseases, and other chronic diseases. UDP-003 is designed to restore the cardiovascular self-repair function and reduce arterial plaque.
Advantages of UDP-003
- Highly conforms to our mechanism of action
- It's working very successfully and is very safe
- On a remarkably accelerated clinical path
- The first true disease modifying drug in the CVD space
- Uniquely disruptive market potential
“A transformational and revolutionary approach”
- Lajos Szente, Leading World Expert on Cyclodextrins
Traditional drugs & animal models typically apply interventions far “upstream” (e.g., reduce the number of harmless circulating LDL particles, most of which will never be oxidized and contribute to atherosclerosis).
Hydroxypropyl Beta Cyclodextrin (HPβCD )
Cyclarity cyclodextrin derivatives have been designed to target only 7-ketocholesterol (7KC), the damaged cholesterol that actually drives atherosclerotic disease, however, we can also engineer them to target a wide variety of hydrophobic molecules.
Cyclodextrins have countless industrial and pharmaceutical applications. Hydroxypropyl Beta Cyclodextrin is currently in clinical trials.
Our Groundbreaking Platform Creates Enormous Opportunities
Because of the hydrophilic / hydrophobic nature of our engineered cyclodextrins, they have the potential to be used for countless health, environmental, and industrial purposes to achieve molecular transport mechanisms previously unavailable.
Platform and Pipeline
We have demonstrated that we are able to remove oxidized cholesterol from diseased cells and cellular membranes in a way that is reducing the overall oxidized cholesterol concentration in the cells.
In fact, we have demonstrated that when we treat even severely diseased foam cells with UDP-003, we can recover their phagocytosis function. Instead of signaling healthy macrophages to join them in an expanding cycle of disease, they appear as recovered and functional macrophages, once again able to protect the body.
Development Status: Cyclarity was awarded one of the first ‘Innovation Passports’ under the United Kingdom’s Innovative Licensing and Access Pathway (ILAP) in 2021. The program provides enhanced early development input, accelerated assessment, rolling clinical reviews, and adaptive authorization.
| Product | Target | Indication | Stage | |
|---|---|---|---|---|
| UDP-003 | 7-Ketocholesterol | CAD, PAD, Carotid Stenosis | Late Preclinical | Lead |
| UDP-003 UDP-003 UDP-003 | 7-Ketocholesterol 7-Ketocholesterol 7-Ketocholesterol | Stroke Recovery Alzheimer’s Niemann Pick Type C | Early Preclinical Early Preclinical Early Preclinical | New Indications |
| UDP-200 UDP-300 | Undisclosed Undisclosed | Macular Degeneration Reversal of Drug Overdoses | Discovery Discovery | New Targets in Discovery |
| Oral UDP-003 | 7-Ketocholesterol | Discovery | Formulation |
We expect phase 1 trials to begin in 2024. Phase 2 readout should be complete in 2026. All our early stage trials will include imaging components to measure plaque impact.
Our diligence data package includes strong safety and efficacy data, and demonstrates our ability to rehabilitate sick foam cells into healthy, functional macrophages. We have commenced cGMP drug product manufacture and GLP toxicity testing; both will complete in early 2023. We have successfully completed our MHRA Scientific Advice Meeting and FDA pre-IND (as well as our ILAP Application and Kick-Off Meetings).
Rounds to Date
- with a launch of $4M
- to carry development through candidate selection and lead testing
- Raise of additional $10M
- to carry development through to initial filings with regulatory agency for human clinical trials
- Underdog Pharmaceuticals rebrands to Cyclarity Therapeutics
About Cyclarity Therapeutics
Corporate Status: Launched from a research program begun in 2016, since founding in 2019 we have raised $14 million in two private equity seed rounds. Our IP assets include strong patent groups with composition coverage. Our proprietary computational modeling platform will allow the design of synthetic molecules targeting a variety of age-related diseases.
Team: Cyclarity’s principals, Michael Kope and Dr. Matthew O’Connor, are leaders in the development of rejuvenation technologies. Our Board includes the principals and Frank Schüler of Kizoo Technology Capital GmbH, our current lead, a part of the Forever Healthy Group in Germany with a $360 million commitment to accelerating rejuvenation biotechnology therapies. We have a team of biology, synthetic chemistry, CMC, and computational experts; and we are supported by critical external partnerships with the premier engineers of custom cyclodextrins, CarboHyde Zrt, in Hungary; and the world’s leading specialists in the development of cyclodextrin-specific simulations, MD.USE, SA, in Spain. Cyclarity owns all intellectual property from these collaborations.
