The “Smart Science” Behind AB101

Why hasn’t anyone been able to successfully create a once-weekly basal insulin? Existing basal insulin replacement therapies use synthetic insulin analogs. An insulin analog is a genetically engineered form of insulin whose structure has been modified by deleting and replacing amino acids. The current standard of care for long-acting insulin analogs are Sanofi’s Lantus (insulin glargine) and Novo Nordisk’s Levemir (insulin detemir). Though there are several therapies in development, it has proved difficult for pharmaceutical companies to create insulin analogs that maintain a basal level of insulin for up to seven days. AntriaBio’s AB101 is not an insulin analog. It is formulated from human recombinant insulin.

There have also been questions around whether insulin analogs have altered binding affinities and activities to the insulin-like growth factor 1 receptor (IGF-1R), which is implicated in several cancers. More data is required to determine the precise mechanisms of how insulin analogs activate IGF-1R. However initial studies show that AB101 functions similarly to human insulin at the insulin receptor and IGF-1R.

What makes AB101 unique? We like to say it’s the “smart science” behind our drug’s formulation, which I briefly mentioned in my previous blog post. In our formulation, we couple a very small molecular weight polyethylene glycol (PEG) molecule, which is roughly 5 kDa in size, to the N-terminus of the B chain of human recombinant insulin. What this does is modify the solubility of insulin, and allows us to encapsulate it in biodegradable microspheres made from PLGA – poly(lactic-co-glycolic acid) – through a novel emulsification process. Microspheres prepared this way have a uniform distribution of insulin inside.

As background, PLGA is commonly used to formulate polymeric nanoparticles as drug delivery systems. Regulatory authorities, including the FDA and European Medicine Agency, have approved several therapies that utilize PLGA for vaccinations, cancer, inflammatory diseases and many other indications. The clinical value of PEGylation of drug therapies is also well established as demonstrated by sales of Roche/Genentech’s Pegasys for chronic Hepatitis C and Amgen’s Neulasta for patients undergoing chemotherapy among others.

Upon injection of AB101, the polymer microspheres are broken down by simple hydrolysis allowing the PEGylated insulin to be released slowly and uniformly over a period of one week. Most importantly, insulin is released without a burst that could cause hypoglycemia in patients. Human insulin’s duration of action is thereby extended without the use of any new excipients.

These are some of my thoughts around what sets AB101 apart from the rest. 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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Mr. Elam currently serves as AntriaBio's Chairman and CEO.

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