Pravastatin Sodium

- 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

SANTA MONICA, Calif.--( BUSINESS WIRE )-- GoodRx , the leading destination for prescription savings in the U.S., today announced it is offering 30 of the most common heart health medications for under $30 at more than 70,000 pharmacies nationwide. 1 Cardiovascular disease is one of the most prominent conditions facing Americans, affecting nearly half of all U.S. adults. That’s why GoodRx is making it easier for all individuals, regardless of insurance status, to access savings on both generic and brand-name medications that mitigate the risk and impact of cardiovascular conditions such as coronary artery disease, high cholesterol, hypertension, and more. By helping people afford their prescriptions, GoodRx is improving health outcomes and reducing the overall strain on the healthcare system. GoodRx’s recent report - The GoodRx Effect - estimates that GoodRx has directly contributed to the prevention of at least 140,000 emergency room visits and 110,000 hospitalizations for major adverse cardiovascular events like heart attack and stroke. Save an average of 84% on common generic medications 2 The following is a sample list of common generic medications used to treat cardiovascular disease that are available for under $30 on GoodRx. MEDICATION LOWEST PRICE 3 AVG % SAVINGS 4 ACE Inhibitors Lisinopril (generic Prinivil and Zestril) $9.29 67% Enalapril (generic Epaned and Vasotec) $15.54 75% Beta Blockers Carvedilol (generic Coreg) $10.68 75% Metoprolol ER (generic Toprol XL) $11.15 74% Propranolol (generic Inderal) $10.96 71% Calcium Channel Blockers Amlodipine (generic Amvaz, Katerzia, and Norvasc) $9.15 80% Diltiazem ER (generic Cardizem CD) $13.43 74% Statins Atorvastatin (generic Lipitor) $10.10 83% Pravastatin (generic Pravachol) $14.53 74% Rosuvastatin (generic Crestor) $10.57 91% Access exclusive discounts and savings on brand-name drugs GoodRx offers incredible savings on brand-name medications that are often more costly and harder to obtain: MEDICATION SAVINGS* Entresto Pay as little as $10 for up to a 90-day supply Jardiance Pay as little as $10 per month Lodoco Pay as little as $30 for up to a 90-day supply Ozempic Pay as little as $25 per month Repatha Pay as little as $5 per month Soaanz Exclusive discount to save over 70% Toprol XL Exclusive discount to save up to 51% Xarelto Pay as little as $10 per fill *May require private or commercial insurance Learn more about cardiovascular disease from trusted doctors, pharmacists and health experts GoodRx Health is a go-to resource for understanding common heart conditions, risk factors, treatment options and associated savings. The GoodRx Heart Health Center provides credible, timely and actionable information to help people better manage their health. Each article is researched and written by a team of editorial experts, and clinical content is reviewed by a team of medical experts that includes physicians, pharmacists, and more. “Improving access to affordable medications is the most important thing we can do to improve Americans’ heart health. The second most important is ensuring access to helpful, accurate information,” said Karla Robinson, MD , Medical Editor at GoodRx. “Knowledge is power, so we create easy-to-understand content that people can actually use so they are better equipped to minimize the risk of disease, find affordable medications, stick to their treatment plans, and ultimately improve their overall health and wellbeing.” To find savings and trusted health information, download the GoodRx app or go to www.goodrx.com/hearthealth . About GoodRx GoodRx is the leading destination for prescription savings in the U.S. We offer consumers free access to transparent and lower prices for generic and brand medications, as well as comprehensive healthcare research and information. We also equip healthcare professionals with efficient ways to find and prescribe affordable medications. Since 2011, GoodRx has helped consumers save more than $65 billion and is one of the most downloaded medical apps over the past decade. GoodRx periodically posts information that may be important to investors on its investor relations website at https://investors.goodrx.com . We intend to use our website as a means of disclosing material nonpublic information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors and potential investors are encouraged to consult GoodRx’s website regularly for important information, in addition to following GoodRx’s press releases, filings with the Securities and Exchange Commission (the “SEC”) and public conference calls and webcasts. The information contained on, or that may be accessed through, GoodRx’s website is not incorporated by reference into, and is not a part of, this press release. 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 consumer savings; the benefits of our offerings to consumers, the U.S. healthcare system and GoodRx; and GoodRx’s plans, expectations and objectives. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, risks relating to our ability to achieve broad market education and change consumer purchasing habits, changes in medication pricing and pricing structures, our reliance on a limited number of industry participants, the competitive nature of our industry, risks related to government regulation of the internet, e-commerce, consumer data and privacy, information technology and cyber-security and the important factors discussed in the section entitled “Risk Factors” in GoodRx’s Annual Report on Form 10-K for the year ended December 31, 2022, as updated by our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, and our other filings with the Securities and Exchange Commission. These factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. 1 Prices are subject to change at any time without notice. Prices may vary at different pharmacies, and for different forms, dosages, and quantities. 2 Calculated based on the difference between the average list price at a particular pharmacy and the average price paid by GoodRx consumers utilizing a GoodRx code at that same pharmacy in December 2023. 3 As of February 1, 2024. 4 Calculated based on the difference between the average list price at a particular pharmacy and the average price paid by GoodRx consumers utilizing a GoodRx code at that same pharmacy in December 2023.