DENVER–(BUSINESS WIRE)–Indication BioScience, a clinical-stage biopharmaceutical company developing next-generation combination therapies for cardiometabolic disease, today announced encouraging early findings from its ongoing Phase I study of Atorvo+™. The investigational therapy combines atorvastatin — the world’s most prescribed cholesterol-lowering statin — with a proprietary orally active solid form of cannabidiol.
Atorvo+™ is being developed as a first-line statin therapy, designed to improve not only cholesterol lowering but also the tolerability and long-term adherence that remain significant barriers to patient outcomes.
Proteomic results suggest that Atorvo+™ may address biological pathways linked to the muscle and metabolic side effects that often lead patients to stop taking statins long term, or never begin in the first place. Proteomics is the large-scale study of proteins — the molecules that carry out most functions in the body. While still an emerging research tool and not yet a validated clinical endpoint, proteomics can provide valuable insight into biological pathways that may be relevant to drug tolerability and response.
A Major Public Health and Cost Challenge
According to CDC data, cardiovascular disease is the leading cause of death in the United States, responsible for one in five deaths and costing the healthcare system more than $410 billion annually. Statins remain the foundation of preventive therapy, with more than 40 million Americans prescribed each year. Yet adherence remains a major challenge: the NIH All of Us Research Program found that fewer than two-thirds of patients achieve adequate adherence, and side effects such as muscle pain, fatigue, or changes in blood sugar are a key driver of discontinuation.
“Statins save lives, but they don’t work if people can’t stay on them, or won’t begin taking them,” said Dr. James Cappola, Chief Medical Officer of Indication BioScience. “For the first time, we’re seeing evidence in humans that combining a statin with an orally active solid form of cannabidiol may influence pathways relevant to tolerability. Our goal is to close the gap between efficacy and tolerability — making it easier for patients to remain on life-saving therapy.”
Early Data: Protective Pathways Engaged
The 28-day Phase I study enrolled healthy adults aged 40–75 and assessed safety, cholesterol levels, and exploratory biomarkers measuring mitochondrial stress and advanced proteomic profiling. Preliminary results suggest that Atorvo+™ may influence biological pathways associated with muscle health, inflammation, and metabolism — areas strongly linked to the side effects that cause statin discontinuation.
While the full clinical study report is expected later this year, the early proteomic data provide a strong mechanistic rationale for Atorvo+™ and support its continued development in patients at risk for statin intolerance.
Proprietary Formulation, New Potential
Cannabidiol has been studied for its effects on inflammation, oxidative stress, and neuromuscular signaling. Atorvo+™ is the first fixed-dose combination to pair it with a statin in a proprietary orally active solid form designed to improve absorption and consistency, overcoming limitations that have historically challenged clinical use.
What’s Next
The company expects to release its full Clinical Study Report in Q4 2025, including validated data on pharmacokinetics, safety labs, lipid panels, metabolic markers, and exploratory endpoints. These results will guide the design of a Phase IIb trial in patients with cardiometabolic risk.
About Indication BioScience
Indication BioScience is a clinical-stage biopharmaceutical company pioneering the Statin+™ platform, a pipeline of fixed-dose combination therapies designed to improve the safety, tolerability, and long-term adherence of statins. By pairing proven statins with complementary agents such as an orally active solid form of cannabidiol, the company aims to unlock better patient outcomes, reduce healthcare costs, and expand preventive therapy to millions of people worldwide.
https://clinicaltrials.gov/study/NCT06615284
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