In a significant development for Long COVID treatment, HealthBio (formerly IncellDx) has announced the initiation of patient pre-registration for a Phase III clinical trial investigating a novel combination therapy of Selzentry (maraviroc) and Lipitor (atorvastatin). The FDA-approved fast-track study will evaluate this innovative treatment approach for patients suffering from Long COVID/Post-Acute Sequelae of COVID (PASC).
Trial Design and Scope
The 32-week study will involve 252 patients in a randomized, double-blind, placebo-controlled, multicenter format. The trial, scheduled to begin in March 2025, will assess both safety and efficacy of the drug combination. Patient eligibility will be determined through symptom questionnaires and FSS fatigue scores.
Scientific Rationale and Preliminary Evidence
Bruce Patterson MD, co-founder and CEO of HealthBio and former Director of Virology at Stanford University School of Medicine, explains the mechanism: "The molecular root cause of Long COVID is activation of pro-inflammatory white blood cells." The treatment targets CCR5 and fractalkine receptors on cell surfaces, addressing vascular inflammation and immune dysregulation through the monocytic-endothelial-platelet axis.
Supporting this approach, a recent study by Harvard Medical School, Stanford Medical School, and Massachusetts General Hospital researchers found that among over 150 treatments evaluated, maraviroc showed the highest percentage of patients reporting significant improvement, with minimal side effects. The study included responses from 3,925 patients, with maraviroc demonstrating particularly positive outcomes in Long COVID cases.
Economic Impact and Market Need
The Centers for Disease Control and Prevention (CDC) estimates that Long COVID affects between 7.7 and 23 million Americans, with an economic impact of approximately $3.7 trillion due to diminished quality of life, lost earnings, and medical expenses. The National Institutes of Health has committed $1.6 billion to the RECOVER initiative to investigate Long COVID causes and treatments.
Funding and Future Prospects
HealthBio has secured $10 million in initial funding, led by Michigan-based Boomerang Catapult. Warner Queeny, Principal of Boomerang Catapult, expressed confidence in the pre-trial clinical data, noting its statistical significance exceeds FDA requirements. The company holds a patent (USPTO #11,180,491b2) for using CCR5 antagonists, including maraviroc, in Long COVID treatment.
Broader Implications
The trial's implications extend beyond Long COVID. HealthBio anticipates that successful outcomes could lead to applications in other chronic inflammatory conditions, including ME-CFS, chronic Lyme disease, and Fibromyalgia. The company's approach, combining data analytics, machine learning, and AI, aims to revolutionize immunology and autoimmune disease treatment.
