HealthBio™ Therapeutics Begins FDA-Approved Fast-Track Clinical Trial for Treatment of Long COVID with a Patented Combination of Maraviroc and Atorvastatin

Novel treatment protocol addresses endotheliitis and immune activation and has potential to address additional chronic inflammatory diseases affecting millions of patients globally

HAYWARD, Calif. & TRAVERSE CITY, Mich.--(BUSINESS WIRE)--HealthBio (formerly IncellDx), an inflammatory disease diagnostic and therapeutic company, today announced it is pre-registering patients for its Phase III clinical trial to investigate the treatment of Long COVID/Post-Acute Sequelae of COVID (PASC) with Selzentry (maraviroc) and Lipitor (atorvastatin) tablets. The 32-week randomized, 252 patient, double-blind, placebo-controlled, multicenter study will evaluate the safety and efficacy of the drug combination for the treatment of patients living with these chronic inflammatory conditions.

The National Institutes of Health (NIH) launched an estimated $1.6 billion initiative, RECOVER, to find the root causes and potential treatments for Long COVID and PASC. Global drug companies began to study the effects of the condition, supported awareness campaigns, and continue to experiment with the extended use of therapeutics originally developed to treat the COVID-19 infection, which show mixed results.

Additionally, the Centers for Disease Control and Prevention (CDC) estimates between 7.7 and 23 million Americans are affected by Long COVID; a condition that is estimated to cost the U.S. economy upward of $3.7 trillion in worsening quality of life, lost earnings and medical expenses. Despite being a significant public health priority, the medical community and patients remain waiting for a better understanding of Long COVID symptoms to emerge and the science to develop to identify effective, safe treatment.

“We recently published research in Nature about the use of machine learning and AI-based precision diagnostics to identify a common thread in chronic inflammatory diseases and believe the molecular root cause of Long COVID is activation of pro-inflammatory white blood cells,” said Bruce Patterson MD, co-founder and CEO of HealthBio. “These white blood cells have many CCR5 and fractalkine receptors on their cell surface, which promote vascular inflammation and immune dysregulation through the monocytic-endothelial-platelet axis. Treatment of this persistent immune response can lead to addressing patients’ fatigue, dysautonomia, and brain fog among other symptoms.”

Former Director of Virology at Stanford University School of Medicine, Dr. Patterson received his M.D. from Northwestern University and is a leading researcher on the effects of viral pathogens on the human immune system. He has contributed to the detection, prognosis and treatment of patients with conditions spanning HIV, HPV and other diseases for more than four decades. Since 2020, his team has focused on Long COVID and PASC, treating more than 12,000 patients with a protocol of maraviroc and atorvastatin to address the CCR5 pathway, reducing vascular inflammation to improve patient outcomes. HealthBio holds a patent (USPTO #11,180,491b2) for the use of all CCR5 antagonists including maraviroc to treat Long COVID.

A recent study, MedRxiv pre-print, “Patient-Reported Treatment Outcomes in ME/CFS and Long COVID,” authored by Harvard Medical School, Stanford Medical School and Massachusetts General Hospital physicians, presents results of a treatment survey with responses from more than 3,925 patients. Of the more than 150 treatments explored, Maraviroc had the highest percentage of patients feeling "much better" of all of the therapies, with almost no negative side effects. According to the study: “Maraviroc, a CCR5 co-receptor antagonist, also had a high percentage of positive responses (from a limited group of 58 patients, mostly with Long COVID).” Earlier research published in Frontiers on Immunology (Persistence of SARS CoV-2 S1 Protein in CD16+ Monocytes in Post-Acute Sequelae of COVID-19 (PASC) up to 15 Months Post-Infection), supports the effectiveness of maraviroc for Long COVID treatment.

In February 2024, HealthBio announced acceptance by the Food and Drug Administration (FDA) to proceed with the clinical trial to support a New Drug Application (NDA) filing through the Fast-Track 505(B)(2) pathway of the Federal Food, Drug, and Cosmetic Act (FDCA).

“The rapid approval fast tracked our efforts to raise capital to fund the trial as well as scale our operations and begin future FDA trials for other indications such as Chronic Lyme. This is positive momentum for physicians and patients alike that are on a quest for managing chronic symptoms and improving lives,” continued Patterson.

HealthBio closed an initial $10M round of funding led by Michigan-based investor Boomerang Catapult. “The HealthBio pre-trial clinical data matches well with the endpoints of the trial. When early data is this strong, with statistical significance far above what the FDA requires, we have confidence in our long-term investment,” said Warner Queeny, Principal of Boomerang Catapult. “We believe HealthBio will demonstrate treatment efficacy and believe there is extraordinary potential for the trial outcome to address a number of other chronic inflammatory diseases such as ME-CFS, chronic Lyme and Fibromyalgia.”

Patients can pre-enroll in the clinical trial, which is set to begin in March 2025, with the HealthBio registration form. Inclusion criteria for the study is collected via symptom questionnaire and based on FSS fatigue score.

About HealthBio

HealthBio is a commercial stage company that has developed proprietary diagnostics and a therapeutic solution to cure vascular inflammation through the use of data analytics, machine learning and AI. The company discovered biomarkers that correlate with specific inflammatory symptoms such as chronic fatigue and other debilitating symptoms. The therapeutic solution treats the root cause of inflammation and offers a cost-effective, short treatment cycle. HealthBio’s mission is to fundamentally change the field of immunology and autoimmune disease and deliver the gateway to cancer prevention and longevity. For more information or investment inquiries, please contact us at https://www.healthbioai.com/.