Post-Lyme Disease Syndrome

- New Company to support New Drug Application- HAYWARD, Calif., Feb. 15, 2024 /PRNewswire/ -- HealthBioAI, 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, HealthBioAI. 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 HealthBioAI. "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. HealthBioAI, 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 HealthBioAI. "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 HealthBioAI. 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 HealthBioAI HealthBioAI, a recently launched company has identified a common thread in chronic inflammatory diseases through the use of machine learning and AI-based precision diagnostics. HealthBioAI 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 . Media Contact: Julie Ferguson [email protected] [email protected] (312) 385-0098 Investor Relations: Chris Wheeler Chief Financial Officer [email protected] [email protected] (415) 595-4911 SOURCE HealthBioAI

New Company to support New Drug Application HAYWARD, Calif., Feb. 15, 2024 /PRNewswire/ -- HealthBioAI, 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, HealthBioAI. 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 HealthBioAI. "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. HealthBioAI, 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 HealthBioAI. "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 pro 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 HealthBioAI. 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 HealthBioAI HealthBioAI, a recently launched company has identified a common thread in chronic inflammatory diseases through the use of machine learning and AI-based precision diagnostics. HealthBioAI 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 . Media Contact: Julie Ferguson media@healthbioai.com Julie@jfprmedia.com (312) 385-0098 Investor Relations: Chris Wheeler Chief Financial Officer investments@healthbioai.com ChrisWheeler@HealthBioAI.com (415) 595-4911 View original content: SOURCE HealthBioAI

Study identifies persistent Lyme bacteria in tissue samples and points to need for clinical studies of combination antibiotics in persistent LymePORTOLA VALLEY, Calif., Nov. 21, 2023 (GLOBE NEWSWIRE) -- Bay Area Lyme Foundation, a leading public foundation sponsor of Lyme disease research in the US, today announced results of a laboratory study published in the peer-reviewed journal Frontiers in Microbiology that identifies seven combination therapies that are superior to courses of single antibiotics for treating persistent Lyme disease in an investigational model. These combination therapies were able to eradicate the bacteria from tissue samples, and the study was conducted by Bay Area Lyme Foundation Scientific Advisory Board member Monica Embers Ph.D., along with other researchers from Tulane University. “Our results support the experience of Lyme disease patients whose symptoms have not resolved after a standard course of antibiotics, and these new data suggest that combination therapy should be investigated in clinical studies for treating persistent human Lyme disease,” said Embers, an associate professor of microbiology and immunology and director of Vector-borne Disease Research at Tulane National Primate Research Center. While none of the single courses of antibiotics eliminated persistent infection in this investigational study, some combinations of already FDA-approved antimicrobial treatments were able to eradicate the bacteria. Specifically, four different dual combinations of antibiotics (doxycycline and ceftriaxone; dapsone and rifampicin; dapsone and clofazimine; doxycycline and cefotaxime) and three triple combinations of antibiotics and antimicrobials (doxycycline, ceftriaxone and carbomycin; doxycycline, cefotaxime and loratadine; dapsone, rifampicin and clofazimine) eradicated persistent infections of Borrelia burgdorferi, the bacteria that causes Lyme disease. “With no FDA-approved treatment for persistent Lyme, these data will bring much-needed hope to the approximately 2 million Americans who live with symptoms such as chronic pain, fatigue, and cognitive dysfunction due to this terrible disease,” said Linda Giampa, executive director of the Bay Area Lyme Foundation. “Importantly, this is yet another study demonstrating the existence of persistent infection following a standard course of antibiotics.” In this study, Borrelia burgdorferi was found in tissue cultures taken after a 28-day course of a single antibiotic treatment, supporting previous data showing that the bacteria can persist following standard treatment. Conversely, viable Borrelia burgdorferi was not detected in cultured tissues following administration of the seven treatment combinations. Previous studies funded by Bay Area Lyme Foundation also found other compounds, including natural botanicals, to show promise in killing Borrelia burgdorferi and superiority over commonly prescribed antibiotics in laboratory research. This study was made possible by Bay Area Lyme Foundation’s science research grant program, which includes support from Project Lyme. About Lyme disease The most common vector-borne infectious disease in the US, Lyme disease is a potentially disabling infection caused by bacteria transmitted through the bite of an infected tick to people and pets, and can be potentially passed from a pregnant mother to her unborn baby. If caught early, most cases of Lyme disease can be effectively treated, but it is commonly misdiagnosed due to lack of awareness and inaccurate diagnostic tests. There are almost 500,000 new cases of Lyme disease each year, according to statistics released in 2018 by the CDC. As a result of the difficulty in diagnosing and treating Lyme disease, up to two million Americans may be suffering from the impact of its debilitating long-term symptoms and complications, according to Bay Area Lyme Foundation estimates. About Bay Area Lyme Foundation Bay Area Lyme Foundation, a national organization committed to making Lyme disease easy to diagnose and simple to cure, is the leading public not-for-profit sponsor of innovative Lyme disease research in the US. A 501c3 organization based in Silicon Valley, Bay Area Lyme Foundation collaborates with world-class scientists and institutions to accelerate medical breakthroughs for Lyme disease. It is also dedicated to providing reliable, fact-based information so that prevention and the importance of early treatment are common knowledge. A pivotal donation from The LaureL STEM FUND covers overhead costs and allows for 100% of all donor contributions to the Bay Area Lyme Foundation to go directly to research and prevention programs. For more information about Lyme disease or to get involved, visit www.bayarealyme.org or call us at 650-530-2439. Media contact: Tara DiMilia Phone: 908-369-7168 Tara.DiMilia@tmstrat.com