On January 23, 2025, Cyclarity Therapeutics made headlines with the announcement of a groundbreaking clinical trial aimed at curing atherosclerosis, a leading cause of cardiovascular disease globally. This drug, primarily focused on 7-ketocholesterol, which is an oxidized form of cholesterol, aims to significantly reduce arterial plaque accumulation.

Tackling the Leading Cause of Death Worldwide

Cardiovascular disease is the most prominent cause of mortality worldwide, and Cyclarity's innovative small molecule drug seeks to address this pressing health issue effectively and affordably. Atherosclerosis, a condition characterized by the buildup of plaques within the arteries, is particularly exacerbated by the presence of oxidized cholesterol.

Clinical Trial Details

The clinical trials will be executed at CMAX, a renowned clinical research facility in Australia, in collaboration with Monash University. These trials mark a pivotal moment not only for Cyclarity but also for the potential treatment of millions at risk for heart attacks and strokes.

Dr. Matthew O’Connor, the CEO of Scientific Affairs at Cyclarity, elaborated on the significance of this trial, expressing, "It’s really a dream come true... to have something that you worked on from the beginning coming all the way to people, and you get to find out if it can actually help people, it’s an amazing feeling."

Mechanism of Action of UDP-003

The key mechanism behind the drug, UDP-003, is to reactivate macrophages, a type of immune cell, to consume arterial plaques. Normally, macrophages struggle to metabolize oxidized cholesterol, leading them to transform into foam cells, which contribute to plaque stability instead of resolution. UDP-003 aims to:

  • Bind 7-ketocholesterol: The drug specifically targets and extracts oxidized cholesterol from macrophages and plaques.
  • Reinstate macrophage function: By removing this oxidized cholesterol, foam cells can revert to their natural state and resume their role in plaque degradation.
  • Support arterial health: This process allows the plaques to diminish and enables healing of the arterial walls over a few months.

Research and Funding

To support the clinical phase of Trials, Cyclarity recently closed a first tranche of Series A funding, amounting to approximately $6.4 million. This funding will facilitate a safety trial involving 72 healthy volunteers, half of whom will receive the drug.

As highlighted by Dr. O'Connor, "We still need to raise at least another $2.6 million to be able to pay for" the second phase of the clinical trial, underlining the ongoing challenge of securing adequate funding in the medical research domain.

Collaboration with Experts

Cyclarity has chosen to work with esteemed professionals such as Dr. Stephen Nicholls, Director of the Monash Victorian Heart Institute. Dr. Nicholls's extensive background in cardiology and collaborative spirit has been pivotal for ensuring the trial’s success. "He’s really just an amazing guy to work with... To have somebody like him be excited about our drug and the potential that it has is just amazing," remarked Dr. O’Connor.

Challenges and Future Prospects

Despite the excitement surrounding UDP-003, the clinical pathway is arduous and requires rigorous scrutiny from regulatory bodies. Dr. O’Connor explained that working with a decentralized healthcare system in Australia is beneficial, allowing for efficient trial progress and communication with relevant committees.

Cyclarity's efforts do not solely rest on atherosclerosis. The company is exploring other potentials linked with oxidized cholesterol, including:

  • Brain aging
  • Alzheimer’s disease
  • Liver disease (particularly non-alcoholic fatty liver)

Realizing the expansive applications for their technology, Cyclarity also contemplates paying attention to environmental issues, specifically nanoplastics and other pollutants.

Conclusion

In conclusion, the innovation of Cyclarity Therapeutics marks a potentially transformative step in tackling atherosclerosis and broader cardiovascular health concerns. The scientific community is hopeful that the advancements showcased in this trial will not only provide tangible health benefits but also validate the damage repair approach in aging biology.

References

[1] Lifespan.io