SAN DIEGO and STOCKHOLM, Aug. 21, 2025 /PRNewswire/ -- CVCO Therapeutics, Inc., a clinical-stage pharmaceutical company focused on microvascular disease, and Karolinska University Hospital, one of the world's leading university hospitals in partnership with Karolinska Institutet, today announced the execution of a research agreement aimed at advancing the understanding and treatment of microvascular dysfunction—in patients at high risk for cardiovascular disease.
Under the agreement, the organizations will initiate a Phase 2 clinical study evaluating a once-daily oral soluble guanylyl cyclase (sGC) stimulator, in patients with type 2 diabetes (T2D)—many of whom will be overweight or obese-- and established microvascular complications. The study will assess the potential to improve myocardial microvascular blood flow using magnetic resonance imaging (MRI) perfusion imaging, supporting cardiac health in this high-risk population. Additionally, the collaboration will investigate whether sGC stimulation enhances red blood cell (RBC) function and provides cardiac protection during myocardial ischemia-reperfusion.
"This collaboration represents an exciting opportunity to explore a novel therapeutic approach for patients with type 2 diabetes who are at high risk for cardiovascular complications," said John Pernow, MD, PhD, Senior Consultant in Cardiology at Karolinska University Hospital and Head of the Cardiology Unit at Karolinska Institutet. "By targeting microvascular dysfunction and red blood cell signaling, we hope to address a major unmet need and improve outcomes for this vulnerable population."
Patients with T2D face a markedly increased risk of cardiovascular disease, including myocardial infarction, and stroke. Clinical outcomes following myocardial infarction are often worse for these patients, who experience greater myocardial injury, a higher risk of recurrent events, and diminished ability to tolerate physical activity. While modern glucose-lowering therapies such as SGLT-2 inhibitors and GLP-1 agonists have shown cardiovascular benefits, there remains a significant unmet need for therapies that target the underlying mechanisms driving cardiovascular complications such as microvascular dysfunction.
Recent research has identified dysfunction in the vascular endothelium—characterized by impaired nitric oxide (NO) bioavailability and increased oxidative stress—as a key contributor to disease progression and potential loss of functional capacity. Notably, new evidence points to a previously unrecognized role for RBCs in mediating cardiovascular injury. Therapeutic interventions that restore NO bioactivity in RBCs have demonstrated the ability to prevent cardiovascular injury and may help improve exercise tolerance, highlighting a novel and promising therapeutic target.
"We are thrilled to partner with the Karolinska University Hospital, a global leader in cardiovascular research, to advance the science of microvascular dysfunction," said Tony Colasin, CEO of CVCO Therapeutics. "We are developing medicines that offer first-in-class potential to restore vascular health, protect the heart and other target organs in patients—many of whom are obese and currently have limited options. This study is a significant step forward in our mission to transform care for people living with microvascular disease."
"This agreement underscores CVCO's commitment to innovative partnerships that drive scientific discovery and clinical progress," said John Rudey, Chairman of the Board at CVCO Therapeutics. "We believe that combining our expertise with the world-class research capabilities of Karolinska University Hospital will accelerate the development of therapies that can make a meaningful difference in patients' lives."
About CVCO Therapeutics
CVCO Therapeutics, Inc. is a clinical-stage pharmaceutical company specializing in microvascular disease. Its subsidiary, Epizon Pharma, has developed CVCO-701 to address accelerated cardiovascular calcification, a major unmet need affecting nearly all kidney disease, diabetic, and pre-diabetic patients—about 100 million in the US. In a Phase 2 trial in dialysis patients, CVCO-701 restored calcification inhibitor protein levels to those seen in healthy individuals, with no reported side effects. Epizon is partnering with Harvard Medical School and Massachusetts General Hospital to study CVCO-701 in calciphylaxis, a life-threatening complication. CVCO-701 enhances nitric oxide mobilization, demonstrated strong activation of cancer cell death in multiple cell lines, and shows potential benefits in COPD by inhibiting lung elastin degradation.
About Karolinska University Hospital
Karolinska University Hospital which dates back to 1932 is ranked one of the top 5 hospitals in the world and is in close partnership for research and education with Karolinska Institutet, one of the world's leading medical universities. Karolinska University Hospital is one of Europe's largest university hospitals and, together with Karolinska Institutet, has a leading role within the field of medical breakthroughs. Through innovation and active collaboration with industry and academia, Karolinska University Hospital is committed to being internationally prominent in medicine, research and education.
Media Contact:
Anthony Colasin
CVCO Therapeutics, Inc.
acolasin@cvco-tx.com
View original content:SOURCE CVCO Therapeutics, Inc.
