What if there were a cure for type 2 diabetes, but most patients couldn’t benefit from it? This is the question that motivated Johns Hopkins University gastroenterologist Ashish Nimgaonkar and his colleagues at the Center for Bioengineering Innovation and Design to found Glyscend, a biotechnology startup that is trying to develop an alternative to a costly and complicated therapeutic approach for the disease. Armed with funding from Johnson & Johnson Innovation’s World Without Disease QuickFire Challenge, Glyscend is now rapidly accelerating toward clinical testing of its novel diabetes treatment.
Nimgaonkar was intrigued by reports that the bariatric surgical procedures used for morbidly obese patients also appeared to confer dramatic improvement in diabetic patients. “Patients who get surgery can go off their insulin and other diabetic medicines without having even lost an ounce of weight,” he says. As evidence has mounted to support the curative effects of this procedure, some medical societies have moved to recommend it to diabetic patients. Over the past year, a growing number of insurers have extended their coverage to bariatric surgery for the treatment of diabetes, but many patients are either ineligible or reluctant to undergo this still-costly and highly-invasive procedure — assuming they even know about it. “Many doctors are not even aware that these endoscopic procedures and bariatric surgery are an option, so many patients don’t even get referred,” says Nimgaonkar.
Current research suggests that the benefits of this procedure arise from reducing the interaction between digesting food and the intestinal wall. The details of this mechanism remain unclear, but could entail direct reduction of caloric intake, as well as altering the production of intestinal hormones that regulate insulin production and glucose regulation. Glyscend aims to replicate this surgical intestinal bypass with a pill which releases a polymer that forms a barrier within the intestine. Other companies have explored similar synthetic barrier-based approaches, including devices such as EndoBarrier — a flexible ‘liner’ manufactured by gi Dynamics that is delivered to the intestine via a non-surgical, endoscopic procedure. But a pill that can deliver equal or superior protection would be far more appealing to many patients.
Selecting the right material has been a crucial challenge, requiring extensive testing to identify patient-friendly materials that can reliably self-assemble into a robust barrier in the environment of the gut. “We made a long list of ‘must-have’ and ‘nice-to-have’ criteria that needed to be met,” says Nimgaonkar. Initially, his group focused exclusively on materials that had an established track record of human testing or clinical use, identifying dozens of candidates that are then subjected to rigorous testing. At present, Glyscend has identified a handful of polymers that appear to be safe and perform as intended in animal models. “We have shown significant reductions in blood glucose after administration of the polymers,” says Nimgaonkar.
Firing up the funds
Initially, the company was scraping by with relatively modest funding from state and federal agencies, but 2016, Glyscend received a big boost. As one of the three winners of the World Without Disease challenge, the company netted $500,000 in funding — beating more than 470 rivals in a competition designed to reward innovative approaches to preventing and treating chronic disease.
“We were seeking cross-sector, technology-based solutions to a ‘big’ unmet medical need, with a focus on lung cancer and diabetes,” says Barry Springer, vice-president of strategy, innovation and research, Janssen BioTherapeutics. “We prioritized innovative, potentially transformative approaches.” The overall QuickFire Challenge awarded $1.5 million to the best applicants with projects in consumer products, medical devices and pharmaceuticals. This award also establishes an open line of collaboration between the two companies, allowing Glyscend scientists to routinely connect with Johnson & Johnson’s internal expertise in the metabolic disease space.
Still, much research lies ahead before Glyscend can even speculate on how well this will work or whether it will work at all. Glyscend is actively focused on developing new formulations with even better safety and efficacy characteristics, with a plan for testing in patients in the near future. “The next six months will be critical,” says Nimgaonkar. “We are planning to see how well this polymer does in a relatively short clinical study early next year.”
Springer has high hopes for Glyscend’s future prospects. “I’m most excited about the potential to cure type 2 diabetes in a safe and noninvasive manner,” says Springer.