Posted on Dec 15, 2020, 3 p.m.
Toraglen, Inc has announced that it’s insulin delivering nanopill technology has been accepted into the FDA’s Emerging Technology Program. The biotechnology company is a preclinical stage company focused on developing proprietary bile acid platforms with the potential to significantly improve drug delivery.
"We are encouraged that our technology was well received by the Emerging Technology Team," said Gerald Rea, CEO "We appreciate the opportunity to gain valuable guidance as we develop a drug delivery platform that has so many potential applications across a wide variety of therapeutic areas.”
The biotech currently has 2 candidates in preclinical testing for the oral delivery of diabetes agents, developing PUDCA for use in diabetes is their lead program. The poly-bile nanoparticle platform is unique in that it eliminates the challenges of oral drug delivery in one simple to fabricate nanopill, according to the company. Additionally, these nanopills localize the delivery of drug agents to potentially improve the efficacy and safety of a range of therapies.
This nanoparticle technology is made up of naturally occurring bile acid polymerized ursodeoxycholic acid; ursodiol is the soluble form of the bile acid that is FDA approved. The company believes that using PUDCA can help to protect large molecules from degrading in the intestines, these vehicles are expected to be taken up by macrophages and moved to sites of inflammation after entering the intestines. Therapeutic doses are significantly lower than required with systemic delivery according to the company.
In addition to benefiting from a closer relationship with the FDA, Toralgen has recently closed an $8.3 million seed funding round, the company plans to use the funds to further develop its novel nanoparticle drug delivery platform and advance industry partnerships. All of the company’s original investors participated in this second seed round. CEO Gerald Rea said, “This is a clear sign of confidence in our drug delivery platform technology and the commercial potential. Our strong preclinical data, growing world-class team, and industry interest give our company and investors great confidence going forward.”
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