HealthBioAI Announces the Acceptance by the Food and Drug Administration (FDA) to Proceed with a Randomized Clinical Trial for the Treatment of Long COVID/Post Acute Sequelae of COVID (PASC) with Selzentry® (maraviroc) in Combination with Lipitor (atorvastatin)

- New Company to support New Drug Application-

HAYWARD, Calif., Feb. 15, 2024 /PRNewswire/ -- HealthBio^AI, a recently launched precision immunology company advancing new science for neglected immune-mediated diseases, today announced that the company's clinical trial design to investigate the treatment of patients with Long COVID/Post-Acute Sequelae of COVID (PASC) with Selzentry (maraviroc) tablets and Lipitor (atorvastatin) tablets is accepted to proceed with a randomized clinical trial. The clinical trial will support a New Drug Application (NDA) filing through the 505(B)(2) pathway of the Federal Food, Drug, and Cosmetic Act (FDCA).

The Clinical Trial is 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/Post-Acute Sequelae of Covid (PASC).

"We are excited to come out of extensive integration to launch our new enterprise, HealthBio^AI. We have combined Machine Learning driven precision diagnostics of IncellDx, a diagnostics company, with our proprietary data analytics AI portal to fuel new drug discovery.  This work has culminated in our first successful filing and acceptance from the FDA for our long COVID clinical trial," said Bruce Patterson, M.D., founder and CEO at HealthBio^AI. 

 "Some people who have been infected with the virus that causes COVID-19 can experience long-term effects from their infection, known as Long COVID or Post-COVID Conditions (PCC). Long COVID is a debilitating condition in which patients often go undiagnosed and without treatment. Symptoms of the disease can last weeks, months or even years and often impact work, daily household tasks, and even getting out of bed. HealthBio^AI, is pleased about the potential therapeutic value of our combination regimen for treatment of Long COVID," said Stefan Glück, M.D, Ph.D.; senior vice president, Medical Affairs at HealthBio^AI. "While the two existing therapies have been individually approved as stand-alone treatments in use for more than a decade for cholesterol and infectious diseases with well documented safety profiles, our research has found that when the therapies are combined, they may hold the key to suppressing the blood vessel inflammation believed to be at the root of Long COVID."

The protocol of maraviroc and atorvastatin addresses the CCR5 pathway, reducing vascular inflammation with the potential to improve patient outcomes.  A study was published earlier this year in a peer reviewed journal where Long COVID patients were given maraviroc (300 mg per oral twice a day) and pravastatin (10 mg per oral daily) showed improvements in both subjective symptoms and the objective measure of the biomarkers that characterize Long COVID.  In 2021, a patent was awarded for the use of maraviroc to treat COVID-19 and Long COVID, which is now held by HealthBio^AI.

About Long Covid
Long COVID is referred to by many names, including Post-COVID Conditions, long-haul COVID, post-acute COVID-19, long-term effects of COVID, and chronic COVID. The term post-acute sequelae of SARS CoV-2 infection (PASC) is also used to refer to a subset of Long COVID. Long COVID may not affect everyone the same way. People with Long COVID may experience health problems from different types and combinations of symptoms that may emerge, persist, resolve, and reemerge over different lengths of time.

Long COVID is estimated to affect nearly 20 million people across the United States and more than 65 million worldwide. Long COVID is broadly defined as signs, symptoms, and conditions that continue or develop after acute COVID-19 infection. This definition of Long COVID was developed by the Department of Health and Human Services (HHS) in collaboration with CDC and other partners.

About HealthBio^AI
HealthBio^AI, a recently launched company has identified a common thread in chronic inflammatory diseases through the use of machine learning and AI-based precision diagnostics.

HealthBio^AI is initially focused on precision immune modulation of neglected diseases, including Long COVID, Chronic Fatigue Syndrome (ME-CFS) and Chronic Lyme Disease. The company aims to improve diagnosis, advance new science, and innovate new medicines for these historically minimally characterized diseases.

For more information or investment inquiries, please contact us at www.healthbioai.com.

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SOURCE HealthBioAI