This week, we’re focusing on the 50th company to join the Breakout Labs portfolio, Glyscend. Glyscend came to us as part of our East Coast Accelerate competition in 2019 thanks to our Johns Hopkins University ambassador, Seema Kacker. We were intrigued by the company’s differentiated approach to treating the twin epidemics of obesity and type 2 diabetes. The team, led by Ashish Nimgaonkar, MD, proposed to build on the successes of gastric bypass surgery in improving blood glucose while reducing body weight… but, without the surgery! They quickly built on the momentum of our funding to close a $20.5 million Series A financing round this year, led by healthcare investors Brandon Capital Partners and Santé Ventures. Glyscend is on track to begin human trials next year.
Gastric bypass, the hard way
With approximately 500 million people living with type 2 diabetes (T2D) worldwide, including 34 million in the United States, many patients fail to achieve and maintain target glucose levels with current standard-of-care escalation therapies which include surgery, pills, and injectables. These traditional therapies can cause side effects, uncontrolled glycemic levels and increased risk for developing retinopathy and cardiovascular disease.
Gastric bypass (bariatric) surgery is exactly what it sounds like: surgeons literally redirect the connection between the stomach and the intestines, in order to avoid the upper gastrointestinal tract. Originally developed to treat extreme obesity, the surgery has been shown to have immediate and profound effects on improving blood glucose while reducing body weight and reducing long-term micro- and macro-vascular complications related to T2D.
It turns out that blocking access to the upper intestine, i.e. the duodenum, can induce a dramatic change in signaling between the gut, liver and brain. Endoscopic interventions that create a barrier in the duodenum are designed to act on this same principle. While very effective, surgical and endoscopic procedures may not be viable options for many T2D patients due to invasiveness, complications and cost.
Gastric bypass, the polymer way
Enter Glyscend. The company is developing a patient-friendly therapy to mimic the beneficial effects of bariatric surgery to improve blood glucose and reduce body weight, while building upon the standard of care for T2D. Glyscend has developed proprietary polymers that interact with the mucus membrane to form a dynamic barrier which prevents interaction between the food and the mucosal surface of the duodenum.
The novel synthetic polymers can be delivered in pill form and are designed to be inert, non-absorbed, and naturally eliminated through the gastrointestinal tract within 24 hours. That means that the overall duration of the treatment could be controlled with proper oral dosing. They are also designed to interact with the mucosal membrane specifically in the targeted parts of the intestine.
Glyscend has conducted extensive preclinical studies in relevant animal models of T2D, which support the safety and efficacy of their compounds. The company is currently completing GLP safety studies and GMP manufacturing scale up with an eye towards human trials in 2021.
Paving the way
Glyscend’s polymer technology platform evolved from research at Johns Hopkins University, where scientists were trying to understand the exact mechanisms behind improved glucose and metabolic regulation following certain types of bariatric surgery. The approach was made possible by the unique multidisciplinary nature of Glyscend’s team, which includes material scientists, gastroenterologists, and biomedical engineers. Glyscend’s CEO, Ashish Nimgaonkar, MD is an engineer-turned-gastroenterologist and the CSO, Thomas Jozefiak, Ph.D., has 30 years of leadership experience in polymer chemistry and materials science with practical experience in med device and drug development, including VP-level roles at GelTex Pharmaceuticals, Genzyme, and Living Proof.
The company has received grants and recognition from the Maryland Innovation Initiative, the National Science Foundation, Johnson & Johnson Innovation, and Janssen Research & Development 2016 World Without Disease QuickFire Challenge. Breakout Labs funding enabled Glyscend to complete preclinical experiments and set up clinical ready manufacturing. With their recent Series A financing, Glyscend will focus on the development of the company’s novel oral polymer therapy for patients with T2D and other metabolic diseases.