Biodel Receives NIH Grant to Continue Development of Concentrated Ultra-Rapid-Acting Insulin for Use in the Artificial Pancreas
In the quest to develop an artificial pancreas, the development of faster-acting insulin is a crucial component – current rapid-acting insulins do not work nearly as quickly as the insulin secreted by a pancreas in someone without diabetes. Encouragingly, Biodel recently announced that the National Institutes of Health (NIH) awarded it a Small Business Innovation Research grant totaling nearly $600,000 to do further research on developing a highly concentrated ultra-rapid-acting insulin. This would not only work much faster than current insulin, but it would also allow for a smaller insulin reservoir, potentially enabling a smaller pump or making room for a separate pump reservoir for glucagon or another hormone (like Symlin or GLP-1). In addition to its potential use in the artificial pancreas, concentrated ultra-rapid-acting insulin would also greatly improve the treatment options for extremely insulin-resistant patients, who must currently take large doses of insulin. We view the NIH funding as an important endorsement of the company’s research and development efforts.
As a reminder, Biodel previously hit a major setback in its development of an ultra-rapid-acting insulin when the FDA declined to approve its original candidate Linjeta in 2010 due to efficacy and tolerability concerns (see new now next in diaTribe #27). Biodel went back to the drawing board to develop revised formulations of Linjeta that leveraged the ultra-rapid-acting technology, but also improved upon the previous limitations. The company now has a new ultra-rapid-acting insulin candidate, and a 130-patient phase 2 trial is slated to begin in the near future and run until the fall of 2013. Assuming all goes well, the company would then progress to a larger phase 3 trial and be able to submit the drug for FDA approval.
Biodel is also working to develop an improved formulation of glucagon that would not require manually mixing glucagon powder with liquid (known as “reconstitution” – an unfortunate reality of current glucagon kits sold by Eli Lilly and Novo Nordisk). The new glucagon could be used in a simple auto-injector device for severe hypoglycemia (similar to an EpiPen for allergic reactions) or put into a two-hormone pump as part of the artificial pancreas. The company hopes to submit the improved glucagon formulation for FDA approval in early 2014. Several other companies are also working on stabilized glucagon formulations, including Xeris (plans to file for FDA approval of an auto-injector device in late 2013), Latitude (seeking a partner), and others. –AW/AB
