Maraviroc

MALVERN, Pa.--(BUSINESS WIRE)-- Venatorx Pharmaceuticals, a private, pre-commercial pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections, announced today several changes to its executive leadership team. Manos Perros, PhD, has been appointed to the Board of Directors as Executive Chairman. Dr. Perros is a distinguished pharmaceutical and biotech executive with an impressive track record that includes more than 25 years in life sciences research and development. He was previously Chief Executive Officer and co-founder of Entasis Therapeutics, where he successfully positioned the company as a leader in the antimicrobial space, resulting in its acquisition by Innoviva in 2022. While at Entasis, Dr. Perros oversaw the development of Xacduro, which recently earned U.S. Food and Drug Administration approval as the first targeted treatment for Acinetobacter baumannii pneumonia. Prior to founding Entasis, Dr. Perros held the positions of Vice President and Head of AstraZeneca’s Infection Research and Early Development organization and Site Head for AstraZeneca’s Boston R&D research center. Dr. Perros also served as Director of the Novartis Institute for Tropical Diseases in Singapore, and Vice-President and Chief Scientific Officer, Antivirals, at Pfizer, where he led an R&D program that culminated in the approval of Selzentry, a first-in-class treatment for HIV. Dr. Perros’ appointment follows the resignation of Christopher J. Burns, Ph.D., who has stepped down as Chief Executive Officer and Director of Venatorx Pharmaceuticals. Additionally, Tomas J. Heyman has stepped down as Non-Executive Chairman of the Board. “On behalf of the entire Company, I would like to personally thank Chris for his dedication and tireless perseverance to lead Venatorx for over 14 years as an innovative pioneer in the fight against anti-microbial resistance. The Board of Directors sincerely appreciates his contributions along with the endless support and leadership that have guided the Company toward achieving its mission. I am delighted to join Venatorx Pharmaceuticals and to have an opportunity to help advance cefepime-taniborbactam through regulatory review and toward FDA approval to address the growing unmet need for novel treatments for patients suffering from multi-drug resistant gram-negative bacterial infections,” Dr. Perros said. “As recent Phase III data in The New England Journal of Medicine established, cefepime-taniborbactam met the primary noninferiority efficacy endpoint and demonstrated statistical superiority to meropenem for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis, while having a similar safety pro meropenem. This therapy has enormous potential and may represent a significant improvement over the standard of care that could support global health efforts to combat antibiotic-resistant infections for patients around the world.” About Venatorx Pharmaceuticals, Inc. Venatorx is a private, late-stage clinical pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections. Venatorx’s lead program, cefepime-taniborbactam, is a clinical-stage antibiotic that successfully completed a Phase 3 study in adults with complicated urinary tract infections (cUTI), including pyelonephritis. In October 2022, BARDA awarded a contract of up to $318M for development and procurement of cefepime-taniborbactam for the treatment of melioidosis and multi-drug resistant infections. Venatorx is also developing an oral antibacterial, ceftibuten-ledaborbactam (formerly known as VNRX-7145), for the treatment of cUTI, including pyelonephritis, caused by certain bacteria in adult patients with limited treatment options; this product is completing Phase 1 and will advance directly to a global Phase 3 cUTI clinical trial. For more information about Venatorx and its anti-infectives portfolio, please visit . Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical development of Venatorx Pharmaceuticals’ product candidates.

- 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