Cyclarity Begins Phase 1 Trial for Heart Disease

On January 13, 2025, Cyclarity Therapeutics, a biotechnology company headquartered at the Buck Institute in California, announced the launch of its first human clinical trial focusing on the treatment of atherosclerosis. This trial represents a significant milestone in the pursuit of innovative therapies aimed at combating this widespread vascular disease.

The Focus on 7-Ketocholesterol

Cyclarity's primary candidate, designated UDP-003, targets 7-ketocholesterol, a harmful oxidized cholesterol variant that accumulates in cells as a function of aging. Atherosclerosis is characterized by the buildup of plaque in the arteries, predominantly caused by this oxidized form of cholesterol. Given that heart disease remains the leading cause of death globally, a successful treatment could potentially benefit the 70 to 80 percent of individuals affected by heart disease, significantly reducing the risk of heart attacks.

Current Treatment Landscape

The existing management strategies for heart disease include a combination of lifestyle and dietary modifications, the use of statins, and surgical interventions. Despite these measures, current treatment modalities are often insufficient and fail to effectively reverse the condition. Hence, if UDP-003 proves successful, it will undoubtedly revolutionize heart disease treatment by addressing the underlying causes of aging-related pathologies.

Trials and Tribulations

Initially, the clinical trials were scheduled to take place in Cambridge, UK, under the oversight of the MHRA—analogous to the US FDA. However, unforeseen delays arose due to bureaucratic backlogs following Brexit:

"The bad thing is that post Brexit, it seems that the MHRA has gotten a bit backlogged and isn’t able to keep up with our current demands on their time. It takes too long to get meetings and responses to applications currently." – Dr. Matthew O'Connor

This led the team to relocate the trials to Australia, where processes are reportedly faster and more efficient. This change, while delaying the start of what is considered a potentially life-changing therapy, signifies progress toward clinical validation.

Leadership and Research Partners

The clinical trials will be conducted at CMAX, a leading clinical research facility in Australia, in collaboration with Monash University. The initiative will be guided by Dr. Nicholls, the Director of the Monash Victorian Heart Institute in Melbourne:

“We are excited to be working with Dr. Nicholls on a groundbreaking advancement in cardiovascular care. As we advance into being a clinical stage company, Cyclarity is focused on bringing truly disease-modifying treatments for the world’s deadliest disease into reality.” – Dr. Matthew O’Connor

The Phase 1 clinical study will explore both single and multiple ascending doses of UDP-003, in addition to a unique segment involving twelve patients suffering from acute coronary syndrome. The primary objectives are to assess the safety of UDP-003 in individuals with pre-existing plaque and to gather preliminary efficacy insights.

Manufacturing and Regulatory Approval

Cyclarity has completed the manufacturing of human-grade drug materials in compliance with Current Good Manufacturing Practices (CGMP). All essential documentation for the trial has been submitted and accepted, paving the way for imminent trial commencement.

Table 1: Overview of Cyclarity's Clinical Trial

Conclusion and Future Prospects

This pivotal trial is not only a momentous occasion for Cyclarity and its partners but also suggests a broader shift in the approach to treating heart disease. By targeting the root causes of aging, this endeavor may lead to novel solutions for age-related diseases. Furthermore, industry stakeholders anticipate that advancements in this field will encourage acceptance of innovative therapies grounded in aging research.

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About the Author

Steve serves as the Editor in Chief, diligently coordinating daily news and educational content related to aging and biotechnology. His experience spans over 600 articles and numerous interviews with leading researchers in the field. Steve's commitment to elevating the discourse on aging research reflects his deeper understanding of biology and statistical analysis, ensuring that disseminated information is both accurate and impactful.

Source: Lifespan.io