Posted on June 25th, 2014
by Nevan Elam
The American Diabetes Association (ADA) recently wrapped up its 74th Scientific Sessions in San Francisco. Since we are headquartered in Menlo Park, we were fortunate to have the conference on our home turf! While AntriaBio did not present at this year’s conference, our team was eager to learn about the therapies and devices that can potentially improve the clinical burden on patients with diabetes. We look forward to participating in future ADA Scientific Sessions.
This year’s Scientific Sessions brought many significant updates. The ADA released a position statement providing guidance for the management of type 1 diabetes in all age groups, including a new HbA1C target of <7.5% for children. A research team at Boston University/Massachusetts General Hospital unveiled results of a study published in the New England Journal of Medicine in adults and teens that tested for five straight days a wearable, fully automated, “bionic pancreas” consisting of an iPhone 4S, DexCom’s G4 Platinum continuous glucose monitor and Tandem’s t:slim infusion pumps, which subcutaneously delivered insulin and glucagon and were wirelessly controlled by the iPhone. Dr. Kasia Lipska, an endocrinologist from the Yale School of Medicine presented research findings that were published in the Journal of the American Medical Association on the cost vs. clinical value of insulin analogs based on private health insurance claims data from 2000 – 2010. It is gratifying to see developments like these as the diabetes epidemic continues to surge globally.
What I personally found interesting were the updates on basal insulin therapies in development. It is exciting to see other companies trying to improve the current basal insulin standard of care. It validates the work we are doing on AB101, our unique formulation of a once-weekly basal insulin.
Sanofi provided positive phase 3 results for Toujeo (U300 insulin glargine), a basal insulin that is being positioned to succeed Lantus, which will lose patent protection next year. Compared to Lantus, patients with type 2 diabetes on Toujeo were 31% less likely to have low blood sugar events at night. All three of Sanofi’s phase 3 EDITION studies in type 1 and type 2 diabetes met their primary endpoints by demonstrating overall blood sugar control similar to Lantus. Toujeo is currently under review by the EMA and the formal acceptance of Toujeo’s NDA submission to the FDA is pending. Despite Lantus soon losing patent protection, I think Sanofi has positioned themselves well to maintain a stronghold on the basal insulin market.
Eli Lilly is aggressively trying to capture a piece of the $10 billion basal insulin market. Lilly, along with their partner Boehringer Ingelheim, presented promising results from studies on LY2963016, an investigational new insulin glargine product that has the same molecular formula as Lantus. Their phase 3 and phase 1 study results showed that LY2963016 is just as safe and efficacious as Lantus in patients with type 1 and type 2 diabetes.
Interestingly, Sanofi is suing Lilly because LY2963016 infringes on four of their patents. The lawsuit triggers an automatic 30-month stay of approval by the FDA, which means Lilly’s product would be kept off the US market until mid-2016. This will allow Sanofi to push Toujeo in the interim.
Lilly is also developing Basal Insulin Peglispro (BIL), a once-daily basal insulin for type 1 and type 2 diabetes. Studies released earlier this year showed BIL demonstrated a statistically superior reduction in HbA1C and lower rates of nocturnal hypoglycemia compared with Lantus for patients with type 2 diabetes. However, there may be potential safety concerns related to observations of elevated triglycerides, decreased HDL-cholesterol (good cholesterol) and elevated liver enzymes suggestive of hepatic inflammation. These findings may be consistent with hepatic lipogenesis (increased production of fat by the liver).
Hanmi Pharmaceuticals, based in South Korea, presented data on their potential once-weekly basal insulin therapy, LAPSInsulin (HM12460A) in type 1 and type 2 diabetes. The peak effect and duration of effect were modeled from a single dose followed by a euglycemic clamp. The results showed that the predicted profile was not conducive to once-weekly dosing. As a result, Hanmi has elected to halt development of LAPSInsulin. They instead plan to pursue a follow-on insulin analog compound, LAPSInsulin 115 (HM12470), which is currently in pre-clinical development. Many have attempted once-weekly basal insulin analogs and none have succeeded. We will continue to keep our eye on Hanmi’s efforts as we believe AB101, our once-weekly basal insulin that utilizes human recombinant insulin, is a far superior product with a more favorable profile.
Thanks for reading my thoughts on what’s going on in the basal insulin market. We strongly believe AntriaBio’s AB101 has incredible potential to alter the treatment paradigm as a novel once-weekly basal insulin therapy. We are excited to continue our work and I look forward to sharing more thoughts with you as we progress. Please feel free to share your comments and questions below. Onward and upward…
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