TC-Based Company Enters FDA Trials For Long COVID Treatment

TC-Based Company Enters FDA Trials For Long COVID Treatment

Traverse City’s Dr. Bruce Patterson has been working for years to develop what he claims is the best treatment option available for patients suffering from long-haul COVID. Now, that medication is one step closer to a gamechanging approval from the United States Food and Drug Administration (FDA).

Last week, Patterson’s company, called HealthBio AI, announced that it has officially received acceptance from the FDA to proceed with a randomized clinical trial for the treatment of long COVID.” If the trial is successful, Traverse City will become the epicenter for a major milestone in the COVID-19 pandemic.

The Ticker first shared Patterson’s story more than a year ago. At the time, the noted physician and researcher had just relocated to northern Michigan from his former home in the Silicon Valley area. He brought his work with him – specifically, an ongoing effort to bring both diagnostic tools and therapeutics to the market to help the medical field deal with the debilitating effects of long COVID.

HealthBioAI’s treatment for long COVID isn’t a totally new drug. Rather, the company is proposing the use of two existing medications: maraviroc, an FDA-approved prescription medicine for the treatment of HIV infection; and atorvastatin, FDA-approved for the treatment of high cholesterol levels.

As Patterson explains it, this particular drug combination can essentially shut off a series of cellular responses to COVID that cause inflammation. By cutting off the creation of inflammatory proteins and minimizing the mobility of those proteins throughout the body, the drug can address many symptoms that patients with long COVID often experience, including fatigue, chronic headaches, migraines, post-exertional malaise, brain fog, ringing in the ears, hot-cold sensitivity, and more. “Essentially, we’re removing the blood vessel inflammation, which is leading to the majority of the symptoms,” Patterson explains.

Patterson says some doctors have already been prescribing this therapeutic option to long COVID patients, with strong results. An FDA approval would take things to the next level.

“It’s been very effective, at least in our hands,” Patterson says of the drug combo. “But there are a lot of advantages, obviously, to getting approved for this particular use.”

Without FDA approval, long COVID treatment is an “off label” use for maraviroc and atorvastatin, a status that can affect everything from how well-known the treatment is, to how willing doctors are to prescribe it, to treatment cost. “Once we’re approved, we’ll get our own drug combination pill, our own label, and our own drug name,” Patterson continues. “But the most important thing is that it’ll be reimbursed by insurers for long COVID treatment. The out-of-pocket is pretty huge right now, and FDA approval will help with that.”

The clinical trial is described in a press release as a “32-week randomized, 252 patient, double-blind, placebo-controlled, multicenter study that is evaluating the safety and efficacy of maraviroc and atorvastatin for the treatment of patients living with long COVID.”

Because the drugs in question treat inflammation, Patterson says there is potential for this same combination to be used for addressing other conditions, including Lyme disease, fibromyalgia, and even Alzheimer’s. He expects HealthBioAI will pursue approvals for those types of uses in the future.

Lowell Gruman of Boomerang Catapult, which has been assisting HealthBioAI in funding the FDA trials, says this milestone isn’t just an exciting one for the millions of Americans living with the debilitating symptoms of long COVID, but also for the Traverse City business community as a whole.

“What we’re trying to do at Boomerang Catapult is grow high-value jobs that support strong families and support our community,” Gruman says. “We’ve got two real strong initiatives right now that we’re starting to see come to fruition: one is the freshwater research and innovation center, and the other is a life sciences/biotech business cluster that includes not just HealthBioAI, but also companies like Atterx and Medicool. If we’re able to pull this off, I think we’re going to materially changed the conversation and the demographics of Traverse City, in a positive way.”

Pictured: Gruman (left) and Patterson (right)

This article was written by Craig Manning and Originally appeared at: