Long COVID continues to affect millions of people, causing ongoing symptoms that impact their daily lives and health. While researchers have been working hard to find effective treatments, there are still no widely accepted solutions. HealthBio™ Therapeutics (formerly IncellDx) is making progress in this area, having received FDA fast-track approval for a phase 3 clinical trial. This trial will test a new treatment using a combination of two existing drugs to reduce inflammation and help the immune system recover. If successful, this approach could also help treat other chronic illnesses.*

Focusing on the Cause of Long COVID

HealthBio’s research suggests that Long COVID is caused by an overactive immune system. Dr. Bruce Patterson, CEO and co-founder of HealthBio, explains that the disease is linked to specific white blood cells that cause inflammation in blood vessels. 

The company’s treatment uses maraviroc (Selzentry), a drug that blocks certain immune receptors, and atorvastatin (Lipitor), a cholesterol-lowering drug that also fights inflammation. By targeting these immune responses, the treatment aims to relieve symptoms which many Long COVID patients experience, such as:

• Fatigue,  
• Brain fog, and 
• Dizziness.

Clinical Trial and FDA Approval

HealthBio’s upcoming phase 3 clinical trial is a major step toward making this treatment widely available. The study will include 252 patients and last 32 weeks. It will be conducted in a controlled setting where neither the patients nor the researchers know who is receiving the real treatment or a placebo. 

Previous studies, including one from Harvard, Stanford, and Massachusetts General Hospital, showed that maraviroc was one of the most effective treatments for Long COVID symptoms. Other research, published in Frontiers in Immunology, supports the idea that lingering COVID-19 proteins in immune cells may be causing the disease.

In February 2024, the FDA approved HealthBio’s request to move forward with the trial under an accelerated approval process called Fast-Track 505(B)(2). This will help bring the treatment to patients more quickly if the trial results are positive.

Funding and Future Uses

To help fund this important trial, HealthBio raised $10 million from Boomerang Catapult, a Michigan-based investment firm. Investor confidence is based on encouraging early trial data. If successful, this therapy could also be used to treat other chronic conditions like:

• Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), 
• Lyme disease, and 
• Fibromyalgia.

The trial is set to begin in March 2025, and patients who meet the criteria can sign up. This study is a major step toward finding a real solution for Long COVID, bringing hope to millions of people dealing with long-term symptoms.

*Business Wire. (2025, February 12). HealthBio™ Therapeutics Begins FDA-Approved Fast-Track Clinical Trial for Treatment of Long COVID with a Patented Combination of Maraviroc and Atorvastatin. https://www.morningstar.com/news/business-wire/20250212177719/healthbio-therapeutics-begins-fda-approved-fast-track-clinical-trial-for-treatment-of-long-covid-with-a-patented-combination-of-maraviroc-and-atorvastatin 

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