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Newly appointed advisors are world-renowned experts in obesity, diabetes, and cardiometabolic diseases, spanning basic biology to late-stage development RICHMOND, Calif.--(BUSINESS WIRE)-- BioAge Labs, Inc. ("BioAge"), a clinical-stage biotechnology company developing therapeutic candidates for metabolic diseases, such as obesity, by targeting the biology of aging, today announced the formation of its Scientific Advisory Board (SAB). The SAB is composed of world-renowned leaders with expertise spanning metabolic disease biology, obesity medicine, and clinical development of blockbuster therapeutics. The SAB will work closely with BioAge's leadership team to advance the company's pipeline of novel treatments for age-related chronic metabolic diseases into mid- and late-stage clinical development. "We are thrilled to be working with this esteemed group of expert scientists and drug developers as we pioneer new approaches to treating age-related metabolic diseases," said Kristen Fortney, Ph.D., co-founder and Chief Executive Officer of BioAge. "Our advisors' wealth of experience across all phases of drug development, from scientific discovery through approval and commercialization, will be instrumental as we advance our lead product candidate into Phase 2 clinical trials for obesity." BioAge's lead product candidate azelaprag is an orally administered agonist of the apelin receptor APJ that has the potential to mimic the effects of exercise. In preclinical studies, azelaprag has demonstrated the ability to significantly increase weight loss while improving body composition and metabolic parameters when administered in combination with GLP-1 receptor agonists. The company plans to initiate a Phase 2 trial in mid-2024 evaluating azelaprag in combination with tirzepatide (Zepbound®) for the treatment of obesity in older adults (link). The members of the BioAge SAB are: Caroline M. Apovian, MD, FACP, FTOS, DABOM, Professor of Medicine at Harvard Medical School and Co-Director of the Center for Weight Management and Wellness (CWMW) at Brigham and Women’s Hospital. A leading expert in clinical management of obesity, Dr. Apovian has co-authored multiple U.S. and international obesity treatment guidelines. She co-founded the American Board of Obesity Medicine and served as President of the Obesity Society from 2017–2018. Cedric Dray, Ph.D., Associate Professor at INSERM and faculty member at the RESTORE Geroscience Center at Université de Toulouse III-Paul Sabatier. Prof. Dray has published multiple papers describing his pioneering work on apelin and is a world expert on the biology of the apelin pathway in aging, muscle physiology, and metabolic disease. The apelin pathway is the target of BioAge’s lead product candidate, azelaprag, expected to enter a Phase 2 trial for obesity starting in mid-2024. William Evans, Ph.D., Adjunct Professor of Human Nutrition at UC Berkeley and Adjunct Professor of Medicine (Geriatrics) at Duke University. As a former VP at GSK, he led the company's Muscle Metabolism Discovery Performance Unit, and has served as an investigator in multiple clinical trials of muscle aging. Dr. Evans was the first to describe sarcopenia, the age-related loss of muscle mass and strength. His research on muscle metabolism, aging, and functional capacity has resulted in more than 350 publications with more than 80,000 citations. Alexander Fleming, M.D., Founder and Executive Chairman of Kinexum, which provides strategic and operational guidance throughout the process of clinical development and drug commercialization. As a supervisory physician at the US FDA from 1986-98, Dr. Fleming led landmark regulatory reviews for first-in-class drugs for diabetes and other metabolic diseases including metformin, statins and insulin analogs. He also heads the not-for-profit Kitalys Institute, founded to catalyze progress in developing drugs and other ways to increase healthy longevity. Narimon Honarpour, M.D., Ph.D., Senior VP and Head of Global Development at Amgen, where he leads a team responsible for shaping program clinical development strategies through deep disease state knowledge and generating clinical trial evidence to enable pipeline progression. Since joining Amgen in 2011, Dr. Honarpour has held diverse roles across both cardiovascular and inflammation therapeutic areas. In 2019, he became head of Translational Medicine, and in his most recent prior role served as VP-Global Development for the General Medicine Therapeutic Area Head and JAPAC Development Head. Tim Rolph, D.Phil., Chief Scientific Officer and Co-Founder of Akero Therapeutics, a company devoted to developing novel therapies for patients with serious metabolic diseases, including efruxifermin, an FGF21 analog, for metabolic dysfunction–associated steatohepatitis (MASH). Previously, as Chief Scientific Officer of Pfizer's Cardiovascular & Metabolic Disease unit, Dr. Rolph oversaw the development of Steglatro (ertugliflozin) for type 2 diabetes and discovery of oral small-molecule GLP1R agonists and inhibitors of PCSK9 and DGAT2. "We are looking forward to working closely with the renowned experts on our SAB to harness the biology of apelin, an exercise mimetic, to improve the lives of patients living with obesity and other metabolic conditions,” said Eric Morgen, MD, co-founder and Chief Operating Officer of BioAge. “We will also leverage their broad expertise in drug development for metabolic diseases to guide the continued advancement of the other programs in our metabolic disease pipeline.” About BioAge Labs, Inc. BioAge is a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. The company’s lead product candidate, azelaprag, is an orally available small molecule agonist of APJ that promoted metabolism and prevented muscle atrophy on bed rest in a Phase 1b trial. In mid-2024, BioAge plans to initiate a Phase 2 trial of azelaprag in combination with tirzepatide for the treatment of obesity in older adults. Azelaprag has the potential as an oral regimen to amplify weight loss and improve body composition in patients on obesity therapy with incretin drugs. BioAge is also developing BGE-100, a structurally novel NLRP3 inhibitor, with plans to IND by the end of 2024. BioAge’s preclinical programs, based on novel insights from the company’s discovery platform built on human longevity data, also address key pathways in metabolic aging.

RALEIGH, N.C., Jan. 10, 2024 /PRNewswire/ -- A new study, "1,5-Anhydroglucitol: A Novel Biomarker of Adherence in Sodium -Glucose Cotransporter 2 Inhibitors," was published online on December 13, 2023, in Diabetes Care, a journal from the American Diabetes Association. The study was conducted by Elizabeith Selvin, PhD, MPH, at the Johns Hopkins Bloomberg School of Public Health. The objective of the study was to evaluate 1,5-anydroglucitol (as measured by the GlycoMark blood test) as a biomarker of Sodium -Glucose Cotransporter 2 Inhibitors (SGLT2i) drug adherence by analyzing users and non-users of SGLT2i in adults with diabetes from the Atherosclerosis Risk in Communities (ARIC) Study. In the study, very low 1,5-anhydroglucitol values were reported in SGLT2i users compared to non-users. The authors of the study conclude, "The very low blood concentrations of 1,5-anhydroglucitol in this community-based cohort support that 1,5-anhydroglucitol may be a useful biomarker of SGLT2i use. Our findings suggest that 1,5-anhydroglucitol may be useful in clinical research and trials as a marker of adherence." This new study data is consistent with previously reported studies which indicate that 1,5-anhydroglucitol may be useful for evaluating short-term effectiveness and assessing patient compliance of SGLT-2i drugs. One such study, "GlycoMark 1,5-Anhydroglucitol Values in Patients Taking SGLT-2 Inhibitors," was recently presented at the American Diabetes Association (ADA) Scientific Sessions. In this study, clinical investigators from Aveon Health (Scottsdale, AZ) conducted a review of their patients treated with an SGLT-2 inhibitor and their corresponding GlycoMark test results. Consistent with the data from Johns Hopkins, very low 1,5-anhydroglucitol values were reported in SGLT2i users relative to non-users. In another study, "1,5-anhydroglucitol is a good predictor for the treatment effect of the Sodium-Glucose cotransporter 2 (SGLT-2) inhibitor in Japanese patients with type 2 diabetes mellitus (Journal of Clinical and Translational Endocrinology)," 1,5-anhydroglucitol was the most reliable indicator of SGLT2i drug effectiveness – with the study authors stating that "1,5-anhydroglucitol has detective ability more useful for patients than HbA1c value or eGFR value." SGLT-2 inhibitors are a relatively new and popular class of drugs for patients with type 2 diabetes. Medicines in the SGLT-2 inhibitor class include canagliflozin, dapagliflozin, emagliflozin, and ertugliflozin. About GlycoMark® Test GlycoMark is an FDA-cleared and CE-marked non-fasting blood test. Since its discovery, the GlycoMark test, a quantitative test for 1,5-Anhydroglucitol (1,5-AG), has been described in more than 1,300 scientific and medical publications. GlycoMark is available at major reference laboratories in the United States and worldwide. About Precision Diabetes, Inc. (PDI) Precision Diabetes, Inc. (Raleigh, North Carolina) is the exclusive supplier of the GlycoMark test in the U.S., Europe, Australia, the Asia-Pacific Region, the Middle East, and Mexico. Precision Diabetes is an emerging leader in enabling precision medicine for diabetes using novel diabetes biomarkers and algorithms. The company's mission is to revolutionize the diagnostic assessment of diabetes by providing a spectrum of unique diabetes tests, spanning the risk of developing diabetes to developing diabetes complications. More information is available at . MEDIA CONTACT Juliana Button 919-390-1391 jbutton@precisiondiabetesinc.com SOURCE Precision Diabetes, Inc.