Sustained Release Exenatide PT302 for T2D Treatment

• SphereDiabetes/Renal/Hepatic

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Summary

Peptron has been developing biweekly (2 weeks) injectable SR formulation product of exenatide since 2006 using proprietary SmartDepot technology. Exenatide is a GLP-1 agonist and has become the major drug for the treatment of type 2 diabetes. Phase 1 study was completed in 2011, and phase 2 study is currently being conducted in Korea in collaboration with Yuhan corporation. NDA to KFDA for the product will be filed in 2016.

Remarkable

SR Exenatide PT302 has been developed using SmartDepot technology, a proprietary technology of Peptron. The SmartDepot technology to make sustained release formulation features a spray-drying process for the efficient encapsulation of drug into bio-degradable carrier, and an ultrasonic nozzle for the homogeneity and size-control of the particle. Microsphere injections of versatile release profiles from days to months can be generated. Long-acting exenatide manufactured by SmartDepot shows ideal PK profile with no lag phase via elaborate control of the initial release. It also has high bioavailability and good injectability with narrow needle size, raising an expectation of more effectiveness and convenience for patients.

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