Today, we will discuss an interview with one of the founders of Cyclarity Therapeutics, shedding light on the challenges biotech companies face when entering the clinical stage. Formerly known as Underdog Pharmaceuticals, Cyclarity is a spin-off from the SENS Research Foundation, focusing on rejuvenation therapies. The company’s main goal is to clear 7-ketocholesterol, a harmful byproduct of oxidative stress, from the body. This substance is linked to age-related inflammation and atherosclerosis development. The groundbreaking approach developed by Cyclarity targets 7-ketocholesterol specifically, aiming to improve outcomes compared to standard treatment with statins. Their innovative drug is now ready for human trials, marking a significant milestone in the company’s journey towards combating atherosclerosis.
During a recent interview, Cyclarity’s founder provided insight into the progress made regarding safety testing and drug manufacturing. The company has successfully completed manufacturing human-grade drug material and is finalizing safety testing before moving forward with human trials. Despite the challenges associated with regulatory approval, Cyclarity’s drug manufacturing process is scalable and cost-effective, ensuring accessibility for those in need. Plans for human clinical trials in the UK have been altered due to regulatory delays post-Brexit, prompting the company to seek faster approval processes in Australia. With the support of key advisors and collaborators, Cyclarity remains committed to advancing their innovative treatment for atherosclerosis.
The upcoming Phase 1 trial will focus on assessing the safety and efficacy of Cyclarity’s drug in patients with arterial disease. This trial will lay the foundation for a more extensive Phase 2 study, aimed at evaluating long-term benefits. Despite the challenges of securing funding and navigating regulatory hurdles, there is optimism in the longevity biotechnology industry. By addressing specific aspects of aging-related diseases, companies like Cyclarity are pioneering new approaches to drug development. The field of aging research continues to evolve, with a growing emphasis on shifting traditional paradigms and embracing innovative strategies to combat age-related illnesses.
