#USA #New York #Cirius Therapeutics #T1D #CIR-0602K

Cirius Therapeutics and Breakthrough T1D Join Forces for Phase 2 Trial

In a significant stride towards better treatment options for Type 1 Diabetes (T1D), Cirius Therapeutics has partnered with Breakthrough T1D and the University of Virginia School of Medicine to initiate a Phase 2 clinical trial of CIR-0602K. This innovative therapy aims to enhance glycemic control and reduce insulin dependency in individuals living with T1D.

Background of the Collaboration

Cirius Therapeutics, renowned for its focus on therapies for insulin resistance-related diseases, has introduced its lead candidate, CIR-0602K, which targets the mitochondrial pyruvate carrier (MPC). This next-generation insulin sensitizer is specially formulated to assist adults using automated insulin delivery systems. Breakthrough T1D, formerly known as JDRF, has provided essential funding for this endeavor, underscoring their commitment to advancing T1D treatments and enhancing the quality of life for patients.

According to Dr. Courtney Ackeifi, a senior scientist at Breakthrough T1D, traditional insulin therapies do not fully address the myriad health challenges faced by T1D patients. "New treatments like CIR-0602K are vital to improve glycemic control and tackle insulin resistance that many individuals experience due to their condition," she remarked.

Study Design and Goals

The study is a randomized, placebo-controlled, double-blind trial set to evaluate the effects of daily 250 mg doses of CIR-0602K over three months. As it stands, this trial will focus on measuring the amount of time participants can maintain stable glucose levels within a healthy range, known as time-in-range. Additionally, it aims to reduce overall insulin consumption while tracking secondary endpoints such as hemoglobin A1c (HbA1c) levels and various cardiovascular health biomarkers. Approximately 34 patients are projected to enroll at UVA Health, marking an important step in understanding how CIR-0602K can benefit people with T1D.

Clinical Significance

Dr. William B. Horton, an Associate Professor of Medicine at UVA and the study's principal investigator, highlighted ongoing challenges for T1D patients, such as heightened cardiovascular risks. He explained how CIR-0602K has previously shown efficacy in improving insulin sensitivity among other populations, and hopes it can provide similar benefits for those with T1D. "The potential to enhance glycemic control while simultaneously mitigating the risk of cardiovascular complications is a crucial outcome we hope to achieve in this trial,” Dr. Horton emphasized.

CIR-0602K has already shown promise in previous studies, with over 300 participants having completed trials with positive results, particularly in terms of glycemic control in type 2 diabetes (T2D) and obesity. Its ability to lower fasting insulin levels and improve metabolic health—without severe side effects commonly associated with prior insulin sensitizers—gives it a unique position in the current landscape of diabetes treatments.

Future Implications

The collaboration between Cirius Therapeutics, Breakthrough T1D, and UVA Health is expected to pave the way for groundbreaking developments in T1D management. Dr. Robert A. Beardsley, President and CEO of Cirius, conveyed his enthusiasm, stating, "This partnership not only explores the efficacy of CIR-0602K for T1D but also provides insights that may enhance treatments for associated conditions such as T2D and other metabolic disorders."

With the trial's enrollment slated to begin in the fourth quarter of 2025, the medical community and patients alike are hopeful that CIR-0602K could represent a significant advancement in managing Type 1 Diabetes and improving patients' overall health outcomes. As the research progresses, it will undoubtedly shine a spotlight on the ongoing efforts to tackle the complex challenges posed by diabetes treatment and management.