First-in-Class Therapies for Gastrointestinal Disease and Metabolic Disorders
The Bilayer Approach
Our novel therapeutic approach and innovative delivery system aim to bring long-lasting benefits to the tens of millions of people who suffer from gastrointestinal conditions and metabolic disorders. Bile acids function as unique modulators of metabolism and motility, and delivery with our proprietary bilayer technology can unlock their full therapeutic potential.
Patients deserve better options. That is why we developed the Bilayer approach.
Bilayer Therapeutics is a development-stage company founded in 2020 by a team of world-renowned drug development and delivery experts and gastroenterologists to stimulate the body’s innate mechanisms for regulating metabolism and motility. With a naturally occurring bile acid (chenodeoxycholate or CDC) delivered via proprietary bilayer tablet technology, the company is developing innovative first-in-class treatments for a range of metabolic and motility disorders.
Metabolic syndrome comprises several indications, including obesity, Type 2 diabetes, stroke and heart disease. Bilayer Therapeutics is using CDC to increase glucagon-like peptide 1 (GLP-1), the key hormone whose receptor is targeted by multiple approved drugs and other incretins such as peptide YY, to treat these conditions and to provide them in an easy-to-take oral format. CDC also activates both established mechanisms of action for treating motility disorders (fluid influx and peristalsis of the colon).
By using CDC, Bilayer Therapeutics aims to offer more effective treatments that will cause fewer side effects for patients.
Produced from cholesterol in the liver and stored in the gallbladder, chenodeoxycholic functions as a unique modulator of human metabolism and motility. And while this bile acid has been approved for use as a therapeutic agent in the upper gastrointestinal tract, its use in the lower GI tract—where many metabolic and motility disorders occur—has not been fully explored.
Since most bile acids are reabsorbed in the small intestine, immediate-release treatments are ineffective and cause unwanted side effects when used in the lower GI tract. That’s why we teamed up with experts at the Langer and Traverso Labs at the Massachusetts Institute of Technology and Dr. Joshua Korzenik, gastroenterologist and Director of the Crohn’s and Colitis Center at Brigham and Women’s Hospital, to develop our proprietary bilayer tablet delivery system.
Rather than relying on single-layer, high-dose rapid-release drugs, Bilayer tablets feature a dual mode of action: A thinner immediate release layer and a thicker, extended-release therapeutic layer. This approach targets the TGR5 receptor on L-cells in the colon (especially in the distal parts) and is the first to activate the body’s natural functions of fluid flow and motility, which are critical in treating metabolic and gastrointestinal disorders.
With the ability to use bile acids in the lower GI tract for the first time, we have built a pipeline with investigational treatments for metabolic and motility disorders, hepatic encephalopathy, ulcerative colitis and Crohn’s disease.
Mechanism of action:
- First-in-class treatment for a range of disorders mediated by the colon
- Naturally occurring bile acid formulation with oral delivery and the potential for a benign side effect profile, proven in humans
- Biphasic slow-release delivery system with unique pharmacokinetic profile for treatment of the entire colon, including distal regions close to the rectum
- Dual mode of action for sustained delivery
- Polymethacrylate-based coating for targeting the cecum, the early part of the colon
Bilayer is led by a team of world-renowned academic, medical and industry professionals with deep drug development, drug delivery and gastrointestinal expertise.
Thomas Collet is a serial life sciences entrepreneur with deep drug development expertise. He serves as President, CEO and Director of Bilayer Therapeutics.
Dr. Collet has founded and led several life sciences companies including ProNAi Therapeutics (subsequently went public, now Sierra Oncology); Neural Intervention Technologies (subsequently acquired by W.L. Gore); and Rubicon Genomics (subsequently acquired by Takara Bio). He also served as Vice President of Business Development at Integrated Protein Technologies, a unit of Monsanto Company that Dr. Collet helped start.
Prior to entering the start-up space, Dr. Collet served as Vice President at Tullis-Dickerson & Company, a healthcare focused venture fund, and as an Engagement Manager at McKinsey & Company.
He earned a PhD in Biological Chemistry from the Massachusetts Institute of Technology and completed post-doctoral studies in Dr. Richard Lerner’s laboratory at The Scripps Research Institute.
Michael Camilleri is a consultant in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester, Minnesota, and is Professor of Medicine, Pharmacology, and Physiology at Mayo Clinic College of Medicine and Science. His research interests include clinical enteric neurosciences, gut neurohormonal control, obesity, irritable bowel syndrome (IBS), and pharmacology and pharmacogenomics; his work is funded by National Institutes of Health.
He has received numerous awards and honors, including the 2012 Ismar Boas Medal from the German Society of Digestive and Metabolic Disease, the 2012 American Gastroenterological Association (AGA) Distinguished Mentor Award, the Janssen Research Award, the AGA Joseph B. Kirsner Award, the AGA Julius Friedenwald Medal in 2021, as well as honorary doctorates from the University of Antwerp (Belgium) and the University of Malta, and he was elected to the membership of the prestigious Association of American Physicians. Dr. Camilleri participates in educational and mentorship activities at Mayo Clinic and has mentored more than 80 national and international postdoctoral fellows and scientists. He maintains an active clinical practice in gastroenterology at Mayo Clinic, specializing in gastrointestinal motility disorders, gastroparesis, and functional GI disorders. He is past-president of the American Neurogastroenterology and Motility Society and the American Gastroenterological Association, former editor of Clinical Gastroenterology and Hepatology and Neurogastroenterology and Motility, and a former associate editor of American Journal of Physiology.
Yen Chen Huang has over a decade of experience as a senior manager in the life sciences sector. He currently serves as Vice President of Diamond BioFund, the largest venture fund dedicated to biotechnology and the first evergreen fund in Taiwan. Prior to joining Diamond BioFund, Mr. Huang worked at Industrial Technology Research Institute (ITRI) in R&D roles as well as an industrial consultant focused on the medical devices sector. He currently serves on the boards of IOPtima Ltd, 3D Global Biotech Inc, EyeYon Medical Ltd and Iridium Medical Technology Co., Ltd. He earned an MSc from National Yang Ming University and a MS in supply chain management from the Massachusetts Institute of Technology.
Dr. Joshua R. Korzenik, one of the leading IBD researchers and key opinion leaders in the country, is director of the Brigham and Women’s Hospital Crohn’s and Colitis Center and assistant professor at Harvard Medical School. Dr. Korzenik has been involved in IBD research and care of patients for almost 25 years, with his research focusing on 1) translational research in IBD and 2) investigating environmental influences in IBD, with a focus on their common nexus of the intestinal microbiome. Dr. Korzenik is the author of almost 60 peer-reviewed articles and research papers. He speaks frequently at professional meetings and is an active member of many professional committees. Dr. Korzenik has been the principal investigator of over a dozen research projects, ranging from studies of diet and probiotics to international comparisons of IBD. Dr. Korzenik earned his bachelor’s degree from Harvard College in 1980 and his medical degree from Albert Einstein College of Medicine in the Bronx, New York, in 1987. He was a resident at Harvard-affiliated Beth Israel Deaconess Hospital in Boston from 1987 to 1990 and fellow in gastroenterology and clinical epidemiology at Yale University School of Medicine Hospital from 1991 to 1994. He is a longstanding member of the medical advisory committee for the New England chapter of Crohn’s and Colitis Foundation of America.
Robert S. Langer is one of 12 Institute Professors at MIT; being an Institute Professor is the highest honor that can be awarded to a faculty member. Dr. Langer has written more than 1,500 articles. He also has over 1,400 issued and pending patents worldwide. Dr. Langer’s patents have been licensed or sublicensed to over 400 pharmaceutical, chemical, biotechnology and medical device companies. Dr. Langer has founded more than 40 companies, including Moderna, that are valued at more than $200 billion. He is the most cited engineer in history (h-index 300 with over 363,000 citations according to Google Scholar).
He served as a member of the United States Food and Drug Administration’s SCIENCE Board, the FDA’s highest advisory board, from 1995 — 2002 and as its Chairman from 1999-2002.
Dr. Langer has received over 220 major awards. He is one of 3 living individuals to have received both the United States National Medal of Science (2006) and the United States National Medal of Technology and Innovation (2011). He also received the 1996 Gairdner Foundation International Award, the 2002 Charles Stark Draper Prize, considered the equivalent of the Nobel Prize for engineers, the 2008 Millennium Prize, the world’s largest technology prize, the 2012 Priestley Medal, the highest award of the American Chemical Society, the 2013 Wolf Prize in Chemistry, the 2014 Breakthrough Prize in Life Sciences and the 2014 Kyoto Prize and the 2022 BBVA Foundation of Frontiers of Knowledge Award. In 2015, Dr. Langer received the Queen Elizabeth Prize for Engineering.
Dr. Langer has received 37 honorary doctorates including honorary degrees from both Harvard and Yale. He received his Bachelor’s Degree from Cornell University in 1970 and his Sc.D. from the Massachusetts Institute of Technology in 1974, both in Chemical Engineering.
Dr. Christoph Steiger is a pharmaceutical researcher, project manager and entrepreneur with experience in academia and industry. He holds a Dr. rer. nat. from the University of Wuerzburg and performed postdoctoral training with Professor Robert Langer and Professor Giovanni Traverso at the Massachusetts Institute of Technology. Dr. Steiger also completed postdoctoral research as a Feodor Lynen Fellow at the Alexander von Humboldt Foundation. He has published multiple manuscripts in high impact journals and holds numerous granted or pending patents.
Giovanni Traverso is an Assistant Professor in the Department of Mechanical Engineering at the Massachusetts Institute of Technology (MIT) and also a gastroenterologist in the Division of Gastroenterology, Brigham and Women’s Hospital (BWH), Harvard Medical School. Dr. Traverso grew up in Peru, Canada and the United Kingdom. He received his BA from Trinity College, University of Cambridge, UK, and his PhD from Johns Hopkins University. He subsequently completed medical school at the University of Cambridge, internal medicine residency at the Brigham and Women’s Hospital and his gastroenterology fellowship training at Massachusetts General Hospital, both at Harvard Medical School. Dr. Traverso’s previous work focused on the development of novel molecular tests for the early detection of colon cancer. For his post-doctoral research, he transitioned to the fields of chemical and biomedical engineering at MIT where he developed a series of novel technologies for drug delivery as well as physiological sensing via the gastrointestinal tract.
His current research program is focused on developing the next generation of drug delivery systems to enable safe and efficient delivery of therapeutics, biomedical device to support new modes of drug administration and sensing a broad array of physiologic and pathophysiologic signals. Additionally, Dr. Traverso continues his efforts towards the development of novel diagnostic tests that enable the early detection of cancer.
David Zhu is the Founding Partner of Kendall Capital Partners based in Boston, MA. Kendall Capital Partners invests in early-stage companies that are incubated by scientific labs from top universities. The firm led a venture investment in Bilayer.
Bilayer Therapeutics, Inc.
One Broadway, 14th Floor
Cambridge, MA 02142
Bilayer Tablet Technology Advantages:
Naturally occurring bile acid formulation
Biphasic slow-release delivery system with unique pharmacokinetic profile
Dual mode of action for sustained delivery in the colon
Polymethacrylate-based coating for colonic targeting