To answer this need, SemBioSys is producing human insulin from genetically engineered safflower. We believe our plant-made insulin will offer dramatic reductions in capital and operating costs and provide an accessible source of insulin to meet this exploding demand. In fact, SemBioSys could meet this increased demand with just three commercial farms.
What We Have Accomplished
We have filed an Investigational New Drug (IND) application with the FDA and have submitted a Clinical Trial Application (CTA) to the appropriate European authorities. Discussions with the US Food and Drug Administration (FDA) have confirmed that safflower-produced insulin is eligible to follow a shortened drug approval process.
In December 2008, we initiated our Phase I/II clinical trial of safflower-produced insulin, now referred to as SBS-1000, in the UK. The trial demonstrated that SBS- 1000 was bioequivalent to a recombinant human insulin with the expected safety profile. Highlights from the analysis were:
- SBS-1000 was bioequivalent to Eli Lilly's Humulin® R, a widely-used human insulin in North America
- SBS-1000 in humans showed pharmacokinetics and pharmacodynamics indistinguishable from Eli Lilly's Humulin® R
- SBS-1000 was well tolerated at pharmacologically active dosages.
What We Are Working On
In addition to traditional insulin, we are working on insulin analogues that provide faster-acting or slow-release options for improved disease control.
We are seeking well-positioned manufacturing and commercialization partners to co-develop plant-derived insulin across the developed and developing world.