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FDA Grants Approval for HealthBioAI's Clinical Trial Testing Selzentry® (Maraviroc) and Lipitor (Atorvastatin) Combination in Treating Long COVID/PASC

Friday, February 16, 2024

HealthBioAI, a newly established precision immunology company focused on advancing innovative solutions for neglected immune-mediated diseases, has announced the acceptance of its clinical trial design aimed at investigating the treatment of patients suffering from Long COVID/Post-Acute Sequelae of COVID (PASC) with Selzentry (maraviroc) tablets and Lipitor (atorvastatin) tablets. The clinical trial, designed to support a New Drug Application (NDA) filing through the 505(B)(2) pathway of the Federal Food, Drug, and Cosmetic Act (FDCA), has been approved to proceed as a randomized clinical trial.

The clinical trial, spanning 32 weeks and involving 252 patients, will be a double-blind, placebo-controlled, multicenter study assessing the safety and efficacy of maraviroc and atorvastatin for treating patients afflicted with Long COVID/Post-Acute Sequelae of COVID (PASC).

HealthBioAI, expressed enthusiasm about the company's inaugural venture, stating, "We are thrilled to unveil HealthBioAI after meticulous preparation. By integrating precision diagnostics from IncellDx with our proprietary data analytics AI portal, we are pioneering new avenues in drug discovery. This milestone of FDA acceptance for our long COVID clinical trial marks a significant achievement."

HealthBioAI, highlighted the debilitating nature of Long COVID and the potential of the combination regimen for treatment, stating, "Long COVID poses significant challenges, often leaving patients undiagnosed and untreated, with symptoms persisting over extended periods. Our research suggests that the combination of maraviroc and atorvastatin, each individually approved for other indications, could offer therapeutic benefits by targeting blood vessel inflammation, a suspected underlying factor in Long COVID."

The protocol involving maraviroc and atorvastatin aims to mitigate vascular inflammation through the CCR5 pathway, potentially leading to improved patient outcomes. Recent findings published in a peer-reviewed journal demonstrated favorable outcomes in Long COVID patients treated with maraviroc and pravastatin, indicating improvements in both subjective symptoms and objective biomarkers associated with Long COVID. HealthBioAI holds a patent for the use of maraviroc in treating COVID-19 and Long COVID, further underlining the company's commitment to addressing this pressing medical challenge.

Long COVID, encompassing various names such as Post-COVID Conditions and long-haul COVID, affects a significant portion of the population worldwide. With an estimated 20 million cases in the United States and over 65 million globally, Long COVID manifests in diverse symptoms and conditions persisting beyond acute COVID-19 infection. This broad definition, developed collaboratively by the Department of Health and Human Services (HHS), CDC, and other partners, underscores the complex and evolving nature of Long COVID.



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