Glyscend is a startup out of Johns Hopkins University developing the first orally ingestible medical device that mimics the effects of bariatric surgery on type 2 diabetes (T2DM). Over the past decade, surgeons have found that patients who undergo bariatric surgery, a procedure intended for chronic weight loss, have acute and long lasting remission of T2DM within days of the procedure. Prompting randomized controlled studies in hundreds of patients, the scientific community believes the duodenum plays a key role in diabetes. That is, the duodenum in a diabetic state is overstimulated and releases an abundance of anti-diabetic hormones. In the hopes of leveraging these insights, various startups are pursuing crude approaches such as intestinal sleeves and thermal ablation to disrupt the release of these hormones. While these approaches show early efficacy, these technologies have safety concerns and require adoption by gastroenterologists, specialists who are not part of the current treatment pathway. Glyscend offers an alternative that patients can take in the comfort of their home and can be prescribed by primary care physicians and endocrinologist. The team believes after conversations with the FDA and regulatory counsel that the technology will be classified as a medical device. Thus, Glyscend is strategically positioned to follow the regulatory pathway of a medical device while benefiting from the business opportunity of a pharmaceutical drug. The team has shown efficacy in small diabetic animal models and has optimized the technology for large animal testing in late 2016 and human studies in 2017.
Johns Hopkins University