Gilbert Disease

News builds on previously announced primary endpoint, which showed up to 83.0% of adults achieved statistically significant improvement in metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%). New data on the secondary endpoint shows up to 52.3% of adults with fibrosis stages F1, F2 and F3 had improvement in fibrosis due to MASH.1 Additional sub-analysis shows up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved an improvement in fibrosis without worsening of MASH.1 Survodutide to advance into Phase III MASH study; results reinforce its potential as a best-in-class MASH treatment and, with ongoing trials in obesity,2 could lead to clinically meaningful benefits across the cardiovascular, renal, and metabolic spectrum. Boehringer Ingelheim today announced breakthrough results from a survodutide Phase II trial sub-analysis that demonstrate up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved an improvement in fibrosis without worsening of metabolic dysfunction-associated steatohepatitis (MASH), versus 25.9% with placebo after 48 weeks of treatment [response difference: 38.6% (95% CI 18.1% - 59.1%), p=0.0005].1 F2 and F3 patient populations are at increased risk of developing liver-related complications.3 The full data results were presented today at the European Association for the Study of the Liver Congress (EASL) 2024 and published simultaneously in TheNew England Journal of Medicine1,4 The secondary endpoint shows that up to 52.3% of adults treated with survodutide (BI 456906) achieved a significant improvement in liver scarring (fibrosis) stages F1, F2 and F3 (mild to moderate or advanced scarring), versus 25.8% with placebo after 48 weeks of treatment [response difference: 26.5% (95% CI 8.37% – 44.66%), p<0.01].1 Today’s news follows data announced earlier this year when the trial met its primary endpoint.5 These results demonstrated that up to 83.0% of adults achieved a statistically significant improvement of MASH versus placebo (18.2%), reinforcing the potential of survodutide as a best-in-class treatment [response difference: 64.8% (95% CI 51.1% – 78.6%), p<0.0001].5 Survodutide is a glucagon/GLP-1 receptor dual agonist with a novel mechanism of action, and the first to show this level of fibrosis benefit in a Phase II MASH trial after 48 weeks of treatment.5,6 The glucagon agonist component in survodutide has the potential to increase energy expenditure7,8 and has a direct impact in the liver, which could contribute to the improvement of fibrosis.5 The GLP-1 agonist component decreases appetite while increasing fullness and satiety.6,9 “I am particularly excited about the findings of the Phase II trial in survodutide, which demonstrate the potential for glucagon agonism, in addition to GLP-1, to both improve MASH and shift the needle on fibrosis,” said Dr. Arun Sanyal, M.D., Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University School of Medicine, and Principal Investigator of the trial. “These data position survodutide as a leading glucagon/GLP-1 receptor dual agonist that could be a game-changer for people living with MASH and clinically significant fibrosis.” An improvement was measured as a decrease of at least one stage in fibrosis after 48 weeks of treatment in this trial.10 Fibrosis is a measurement of the progression of MASH,11 a progressive disease impacting more than 115 million people worldwide.12 MASH is caused by inflammation of the liver that can lead to fibrosis,13 and severe tissue scarring (cirrhosis) can substantially increase the risk of end-stage liver disease and liver cancer.14,15 A liver transplant may be the only treatment option at this stage,16 which can place significant financial strain on healthcare systems.17 Liver fibrosis typically worsens slowly,18 and it is easy to go undetected if the fibrosis is not extensive.19 The reversal of liver fibrosis is often challenging for advanced stages of scarring and may not be possible for cirrhosis.20 In this Phase II trial, survodutide also demonstrated significance versus placebo for all other secondary endpoints after 48 weeks of treatment.1 Actual treatment results showed that up to 87.0% of adults achieved at least a 30% relative reduction in liver fat versus 19.7% with placebo, as well as a relative reduction in liver fat content of up to 64.3% versus 7.3% with placebo.1 The absolute change from baseline in Non-alcoholic Fatty Liver Disease Activity Score (NAS, which is used to measure improvement in MASH) in actual treatment results was up to -3.3 with survodutide versus -0.4 with placebo.1 “Today’s breakthrough fibrosis results further reinforce survodutide’s potential as a best-in-class treatment for people living with MASH. We will advance quickly into Phase III trials,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. “New treatments are urgently needed for MASH, a disease connected with cardiovascular, renal and metabolic conditions like obesity, and we are excited to continue these important discussions with healthcare authorities.” Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally. Zealand has a co-promotion right in the Nordic countries. In this trial, survodutide demonstrated safety data consistent with GLP-1 based molecules, with no new safety data concerns.1 Survodutide was granted U.S. Food and Drug Administration (FDA) Fast Track Designation in 2021,21 and the European Medicines Agency (EMA) granted access to the Priority Medicine (PRIME) Scheme for MASH with fibrosis in November last year.22 Survodutide is also being explored in five Phase III studies for people living with overweight and obesity,2,23,24 both of which are associated with MASH.25 An additional Phase III trial is evaluating if survodutide helps people living with overweight or obesity, with a confirmed or presumed diagnosis of MASH, reduce liver fat and lose weight.26 Notes to Editors About the data Boehringer Ingelheim’s Phase II study in MASH and fibrosis stages F1, F2 and F3 included two analyses: planned (assigned dose at randomization) and actual (dose at the end of treatment).1This press release reports on actual data results for participants (295 patients were randomized, and 293 received at least one dose of treatment and were analyzed) across both the primary and secondary endpoints. The additional sub-analysis among people with fibrosis F2 and F3 was conducted among patients with paired biopsies (223 of 293 patients had fibrosis F2 and F3 at baseline (76.2%) of which 170 had paired biopsies).1 Use of MASH terminology Boehringer Ingelheim’s Phase II trial is registered on clinicaltrials.gov as ‘A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)’. This trial was registered prior to a 2023 update in nomenclature made by a number of multinational liver societies including EASL, AASLD and ALEH.27 Their recommendation was to update non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD), and to update non-alcoholic steatohepatitis (NASH) with metabolic dysfunction-associated steatohepatitis (MASH).27 To reflect these recommendations, Boehringer Ingelheim has adopted the use of MASH to describe this Phase II trial. About metabolic dysfunction-associated steatohepatitis (MASH) MASH is a chronic and progressive liver disease caused by a build-up of fat in the liver,13,28 and is a more severe form of metabolic dysfunction-associated steatotic liver disease (MASLD).29 In the US, cases of MASH are predicted to rise by 63% between 2015 and 2030, from 16.5 million to 27.0 million cases.16 MASH is a disease closely associated with connected cardiovascular, renal, and metabolic diseases,30,31 and it is estimated that 34% of people living with obesity also have MASH.25 MASH severity is assessed using a scale that ranges from F0 to F4, which measures the level of fibrosis (scarring):32 F0-F1: indicates no or mild fibrosis F2-F3: indicates moderate or advanced fibrosis F4: indicates cirrhosis About the trial (NCT04771273) This is a Phase II, randomized double-blind placebo-controlled dose-finding trial of 295 participants that evaluates weekly subcutaneous injections of survodutide in people living with MASH and fibrosis (F1, F2 and F3) among adults both with and without type 2 diabetes.10 The primary endpoint of trial is the percentage of participants achieving histological improvement of MASH without worsening of fibrosis after 48 weeks of treatment.10 A histological improvement of MASH is defined as a decrease of ≥2 points on the Non-alcoholic Fatty Liver Disease Activity Score (NAS – total score ranges from 0-8), including ≥1 point decrease in NASH sub-score for lobular inflammation or ballooning, and no increase in fibrosis stage.10 The NAS represents the sum of scores for steatosis (a build-up of fat in the liver33), lobular inflammation (inflammatory cells34) and ballooning (a type of liver cell degeneration35). Secondary outcome measures include:10 At least 30% relative reduction in liver fat content after 48 weeks of treatment compared to baseline Absolute and relative change of liver fat content from baseline after 48 weeks of treatment Improvement of fibrosis, defined as at least one stage decrease in fibrosis stage after 48 weeks of treatment Absolute change from baseline in total score for NAS after 48 weeks of treatment The trial consisted of dose escalation to either 2.4mg, 4.8mg and 6.0mg treatment groups for up to 24 weeks, and dose maintenance for 24 weeks.10 About survodutide (BI 456906) Survodutide is a glucagon/GLP-1 receptor dual agonist that activates both the glucagon and GLP-1 receptors, which are critical to controlling metabolic functions.6 Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally. Zealand has a co-promotion right in the Nordic countries. Survodutide is part of Boehringer Ingelheim’s research and development portfolio in the cardiovascular, renal, and metabolic disease areas. Survodutide was granted U.S. FDA Fast Track Designation in May 2021 for the treatment of MASH and fibrosis,21 and it was accepted to the EMA PRIME scheme in November 2023.22 Boehringer also studied survodutide in a 2-part Phase I trial among people with cirrhosis (F4) and varying degrees of liver dysfunction.36 The purpose of Part 1 was to find out whether cirrhosis (F4) and varying degrees of liver dysfunction influences how survodutide is taken up in the body, and the purpose of Part 2 was to find out whether having cirrhosis (F4) and varying degrees of liver dysfunction influences how people with overweight and obesity tolerate survodutide treatment for 28 weeks.36 Survodutide is also being evaluated in five Phase III studies for people living with overweight and obesity.2,23,24 SYNCHRONIZE-1 and SYNCHRONIZE-2 include sub-populations of patients with comorbidities, without and with type 2 diabetes, respectively.2 SYNCHRONIZE-CVOT includes a sub-population of patients with cardiovascular disease, chronic kidney disease, or with risk factors for cardiovascular disease.2 SYNCHRONIZE-JP in Japan and SYNCHRONIZE-CN in China are exploring survodutide for sub-populations of people living with obesity.23,24 SYNCHRONIZE-JP explores the relative change in liver fat from baseline to week 76 when treated with survodutide versus placebo, as a key secondary endpoint.24 An additional Phase III trial called SYNCHRONIZE-MASLD is evaluating if survodutide helps people living with overweight or obesity, with a confirmed or presumed diagnosis of MASH, reduce liver fat and lose weight.26 The double-blind 48-week, placebo-controlled trial initiated enrollment in March this year.26 About Boehringer Ingelheim Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at (UK and Ireland) or (rest of world). Boehringer Ingelheim’s Intended Audiences Notice This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business. References: 1 Sanyal, Arun J. "Glucagon and GLP-1 receptor dual agonist survodutide improved liver histology in people with MASH and fibrosis: Results from a randomized, double-blind, placebo-controlled phase 2 trial”. Oral presentation at European Association for the Study of the Liver Congress, Milan, Italy. 7June 2024. Abstract #LB117, presentation #GS-006. 2 “Phase III studies to investigate survodutide for people living with obesity and overweight, with and without diabetes, cardiovascular disease and chronic kidney disease.” Boehringer Ingelheim. Accessed June 2024 3 Sanyal, Arun J., et al. “Prospective Study of Outcomes in Adults with Nonalcoholic Fatty Liver Disease.” The New England Journal of Medicine. Vol. 385, no. 17, 2021, pp. 1559-1569. doi: 10.1056/NEJMoa2029349 4 Sanyal, Arun J., et al. “A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis.” The New England Journal of Medicine. June 2024. doi: 10.1056/NEJMoa2401755 5 Top-line Results From A Study to Test Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3).” Boehringer Ingelheim. Data on > 6 Zimmerman, Tina, et al. “BI 456906: Discovery and preclinical pharmacology of a novel GCGR/GLP-1R dual agonist with robust anti-obesity efficacy.” Molecular Metabolism. Vol. 66, Dec. 2022, p. 101633. doi: 10.1016/j.molmet.2022.101633. 7 Tan, Tricia M., et al. “Coadministration of glucagon-like peptide-1 during glucagon infusion in humans results in increased energy expenditure and amelioration of hyperglycemia.” Diabetes. Vol. 62, no. 4, Mar. 2013, pp. 1131-36. doi: 10.2337/db12-0797 8 Salem, V., et al. “Glucagon increases energy expenditure independently of brown adipose tissue activation in humans.” Diabetes, Obesity and Metabolism. Vol. 18, no. 1, Nov. 2015, pp. 72-81. doi: 10.1111/dom.12585. 9 Shah, Meera, and Adrian Vella. “Effects of GLP-1 on appetite and weight.” Reviews in Endocrine and Metabolic Disorders. Vol. 15, no. 3, May 2014, pp. 181 – 87. doi: 10.1007/s11154-014-9289-5. 10 “A Study to Test Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3).” ClinicalTrials.gov. classic.clinicaltrials.gov/ct2/show/NCT04771273. Accessed June 2024 11 Stål. Per. “Liver fibrosis in non-alcoholic fatty liver disease - diagnostic challenge with prognostic significance.” World Journal of Gastroenterology. Vol. 21, no. 39, Jan. 2015, p. 11077. doi: 10.3748/wjg.v21.i39.11077 12 “International NASH Day June 10, 2021.” Global Liver Institute. June 2021. Accessed June 2024 13 Ramai, Daryl, et al. “Progressive Liver Fibrosis in Non-Alcoholic Fatty Liver Disease.” Cells. Vol. 10, no. 12, Dec. 2021, p. 3401. doi: 10.3390/cells10123401. 14 Dyson, Jessica, et al. “Hepatocellular cancer: The impact of obesity, type 2 diabetes and a multidisciplinary team.” Journal of Hepatology. Vol. 60, no. 1, Jan. 2014, pp. 110–17. doi: 10.1016/j.jhep.2013.08.011. 15 Adams, Leon A., et al. “Non-alcoholic fatty liver disease and its relationship with cardiovascular disease and other extrahepatic diseases.” Gut. Vol. 66, no. 6, Mar. 2017, pp.1138-53. doi: 10.1136/gutjnl-2017-313884 16 Estes. Chris, et al. “Modelling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease.” Hepatology. Vol 67, no. 1, Dec. 2017, pp. 123-33. doi: 10.1002/hep.29466. 17 Khalil, Amjad, et al. “New Developments and Challenges in Liver Transplantation.” Journal of Clinical Medicine. Vol 12, no. 17, Aug. 2023, pp 5586. doi: 10.3390/jcm12175586. 18 Kumar, Rahul, et al. “A practical clinical approach to liver fibrosis.” Singapore Medical Journal. Vol. 59, no. 12, Dec. 2018, pp 628-633. doi: 10.11622/smedj.2018145. PMID: 30631885; PMCID: PMC6301869. 19 Pinzani, Massimo, et al. “Fibrosis in chronic liver diseases: diagnosis and management.” Journal of Hepatology. Vol. 42, no. 1, April 2005, S22-36. doi: 10.1016/j.jhep.2004.12.008 20 Zhang, Chun-Ye, et al. “Treatment of liver fibrosis: Past, current, and future.” World Journal of Hepatology. Vol. 15, no. 6, June 2023, pp. 755-74. doi: 10.4254/wjh.v15.i6.755. 21 “Boehringer Ingelheim and Zealand Pharma Received FDA Fast Track Designation for Investigational Treatment for NASH.” Boehringer Ingelheim. Accessed June 2024 22 “List of medicines currently in PRIME scheme.” European Medicines Agency. December 2023. Accessed June 2024 23 “A Study to Test Whether BI 456906 Helps Chinese People Living With Overweight or Obesity to Lose Weight.” Clinicaltrials.gov. clinicaltrials.gov/study/NCT06214741. Accessed June 2024 24 “A Study to Test Whether BI 456906 Helps Japanese People Living With Obesity Disease (SYNCHRONIZE™JP).” Clinicaltrials.gov.clinicaltrials.gov/study/NCT06176365. Accessed June 2024 25 Quek, Jingxuan, et al. ”Global prevalence of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in the overweight and obese population: a systematic review and meta-analysis.” The Lancet Gastroenterology & Hepatology. Vol. 8, no. 1, Jan. 2023, pp. 20-30. (22)00317-X 26 “A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight”. Clinicaltrials.gov. Accessed June 2024. 27 Multinational liver societies announce new “Fatty” liver disease nomenclature that is affirmative and non-stigmatizing.” EASL.easl.eu/news/new_fatty_liver_disease_nomenclature-2. Accessed June 2024 28 “Nonalcoholic Fatty Liver Disease (NALFD) and NASH.” National Institute of Diabetes and Digestive and Kidney Diseases. . Accessed June 2024 29 “Nonalcoholic steatohepatitis (NASH): Symptoms & complications (2023).” American Liver Foundation. liverfoundation.org/liver-diseases/fatty-liver-disease/nonalcoholic-steatohepatitis-nash/. Accessed June 2024 30 Musso, Giovanni, et al. “Association of non-alcoholic fatty liver disease with chronic kidney disease: a systematic review and meta-analysis.” PLoS Medicine. Vol. 11, no. 7, July 2014, p. E1001680. doi: 10.1371/journal.pmed.1001680. 31 Schnell. Oliver, et al. “CVOT Summit Report 2023: new cardiovascular, kidney, and metabolic outcomes.” Cardiovascular Diabetology. Vol. 23, no. 1, Mar. 2024. doi: 10.1186/s12933-024-02180-8. 32 Kleiner, David E., et al. “Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease.” Hepatology. Vol. 41, no. 6, June 2005, pp. 1313-21. doi: 10.1002/hep.20701. 33 “Non-alcoholic fatty liver disease (NAFLD).” NHS. . Accessed June 2024 34 Vanderbeck, Scott, et al. “Automatic quantification of lobular inflammation and hepatocyte ballooning in nonalcoholic fatty liver disease liver biopsies.” Human Pathology. Vol. 46, no. 5, May 2015, pp. 767-75. doi: 10.1016/j.humpath.2015.01.019. 35 Caldwell, Stephan, et al. “Hepatocellular ballooning in NASH.” Journal of Hepatology. Vol. 53, no. 4, Oct. 2010, pp 719-23. doi: 10.1016/j.jhep.2010.04.031. 36 “A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906.” Clinicaltrials.gov. clinicaltrials.gov/study/NCT05296733. Accessed June 2024

BUFFALO, N.Y., Sept. 27, 2023 /PRNewswire/ -- Graves Gilbert, a multispecialty clinic comprised of more than 200 providers representing over 30 medical specialties in Bowling Green, Kentucky, and surrounding counties, is proud to announce a collaboration with Circuit Clinical , an integrated research organization, to bring clinical trials to patients in South Central Kentucky. The partnership supports broader efforts to bring clinical research to community settings, advance medical treatments, and improve equitable healthcare for diverse and medically underserved rural communities. Continue Reading Graves Gilbert Clinic logo Graves Gilbert and Circuit Clinical will partner to reduce the burden on patients who opt in for research participation. Localizing research participant care within Graves Gilbert's physician offices, Circuit Clinical supports the care provider team with embedded staff who have clinical trial experience and work side-by-side with the physicians in practice. "We look forward to continuing to serve our diverse communities by offering patients access to clinical trials and cutting-edge treatments all from the comfort of our offices, with the physicians they know and trust," said Chris Thorn, CEO of Graves Gilbert. "Simply put, we are honored to be chosen by Graves Gilbert to help them bring clinical trials to their patients," said Dr. Irfan Khan, CEO of Circuit Clinical. "Graves Gilbert's commitment to serving communities of every background and focus on patient safety are a perfect match to Circuit's belief in working together to improve clinical trial access for all." The partnership is possible through Labcorp, a global innovative and comprehensive laboratory services leader. Labcorp, the primary reference laboratory for Graves Gilbert, will help identify clinical trials for which Graves Gilbert patients may be eligible, and the parties will work together to enroll patients into the trials quickly. "Our partnership with Circuit Clinical aims to improve patient outcomes by bringing clinical trials to Labcorp's diagnostic customers," said Amy Rhine-Pallas, Senior Vice President of Labcorp's North Central Division. "This collaboration demonstrates the commitment of Labcorp, Graves Gilbert and Circuit Clinical to improving the health and lives of patients in Southern Kentucky by providing them a greater opportunity to participate in innovative medical research that will advance medicine and lead to better health outcomes." Patients enrolled in a clinical trial might also participate in hybrid care options through Circuit Clinical's telemedicine and fully decentralized trial solutions. These alternative options can help reduce traditional clinical research obstacles preventing patient participation. Furthermore, patient involvement in research provides several benefits to both individuals and communities, including: Offering extra care visits without co-pays Strengthening the patient-provider relationship Improving health outcomes through a better and more personal care experience Click here to learn more about the clinical trial program at Graves Gilbert in partnership with Circuit. About Graves Gilbert In 1937, G.Y. Graves and J.T. Gilbert forged an unlikely partnership and embarked on a journey the outcome of which no one could have predicted. Today, Graves Gilbert Clinic houses more than 200 providers representing 30 medical specialties, who continue to lead the way in medical innovation and technology and serve South Central Kentucky with the same level of care and dedication that their founding fathers promised over 85 years ago when Dr. Graves and Dr. Gilbert shook hands and made a commitment to the future: A commitment to a Lifetime of Care. About Circuit Clinical Circuit Clinical, one of the fastest-growing integrated research organizations in the USA, is dedicated to empowering patients to choose clinical research as a care option. Circuit is committed to transforming the experience of finding, choosing, and participating in clinical research for physicians and their patients. The company delivers clinical research services and an award-winning patient engagement platform, trialjourney.com. Learn more at circuitclinical.com and follow along for updates and announcements on LinkedIn. About Labcorp Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's more than 60,000 employees serve clients in over 100 countries, worked on over 80% of the new drugs approved by the FDA in 2022 and performed more than 600 million tests for patients around the world. Learn more about us at . For additional questions or inquiries, please contact the following: Graves Gilbert Chris Thorn CEO, Graves Gilbert [email protected] Circuit Clinical Candice Kent VP of Marketing and Communications [email protected] Labcorp Kimbrel Arcuelo [email protected] SOURCE Circuit Clinical

NASA announced that four astronauts will launch to the International Space Station (ISS) by August 25 on a six-month science expedition to perform research to improve healthcare options on Earth. Launched from the Kennedy Space Center, NASA's SpaceX Crew-7 astronauts will bring multiple research investigations sponsored by the ISS National Lab. Among the various studies, researchers from the University of California San Francisco will perform tissue chip investigations to better understand the correlation between liver regeneration and immune aging to find new ways of improving the liver healing process. Tissue chips are small devices that can model the ways human tissue functions. The chips will allow researchers to study age-related liver dysfunction and regeneration commonly seen in elderly individuals using liver tissue mimics in a microgravity setting. The month-long investigation from UC San Francisco will help researchers understand the correlation between immune aging and healing outcomes at a faster pace they can on Earth, since many space-related physiological changes resemble ones that happen during the aging process. After exposure to microgravity, such changes are more or less reversed after reentry, which allows for a bidirectional investigation of the aging process. Through the investigation researchers hope to determine how the immune aging process can be reversed here on Earth. "Sending these immune chips into space will enable us to simulate the aging process of the immune system and understand how it affects our body’s ability to repair itself as we grow older," Sonja Schrepfer, professor of surgery at UCSF and lead of the investigation, said in a statement. THE LARGER TREND In October, SpaceX's 5th Commercial Crew mission began a six-month venture into space-based research, including an investigation to create a protein-based artificial retina and evaluate how gut microbes change in space. As space exploration increases, health and safety concerns are prevalent. Companies such as the Translational Research Institute for Space Health (TRISH) at Baylor College of Medicine are studying space health and partnering with companies to evaluate how those findings can, in turn, be used to improve human health on Earth. In 2021, TRISH launched EXPAND (Enhancing eXploration Platforms and Analog Definition). This research platform collects data from flights and keeps it in a centralized database to study and improve the health of astronauts and find innovations for use on Earth.