Successfully completed Phase 1 and 2 - PT302 (SR-exenatide for T2D Diabetes)
Peptron has developed formulation of PT302 which has several advantages compared to marketed products such as improvement of patient compliance with longer duration of releasing, less toxic due to use of glacial acetic acid, non-toxic class 3 solvent rather than other toxic solvent, improvement of syringeability which can reduce the pain of Injection with smaller gauged needles. Its exclusive rights will be protected by 2028 (or 2027 for S. Korea) with patents.
Phase 1 study of PT302 was successfully completed in 2011 and Phase 2 study was done with diabetes patients at 15 hospitals in Korea under collaboration of Yuhan Corporation who has sales exclusivity for Korean market. During the studies, PT302 shows ideal PK profile, outstanding injectability and high bioavailability. Peptron is also developing a once monthly formulation (PT304) and currently, preparing Phase 3 to get approval of PT302.
All PT302 dose groups had a significantly greater HbA1c reduction than the placebo group
IND Approval - PT320 (SR-Exenatide for Parkinson¡¯s Disease)
As researchers at NIH (NIA) have discovered the use of exenatide for the treatment of neurodegenerative diseases and showed with extensive in vitro and in vivo studies in models of Parkinson's disease, Exenatide can be a potential disease modifying treatment option for Parkinson¡¯s disease. .
Peptron has received the IND approval for Phase 2 clinical trial in Parkinson¡¯s disease in Korea (PT320) and is also preparing Phase 2 clinical study in abroad.
Peptron assumes its study outcomes are very promising because UCL group shows the efficacy of exenatide for Parkinson¡¯s disease in human trials so we would show it again with regulatory applicable data and select appropriate dosing of SR-Exenatide during official clinical study.
SR formulation Development with New API
Peptron has a platform technology, SmartDepot¢â to make sustained release formulation in different therapeutic area and collaboration experiences with multi-national Pharma. Now, Peptron¡¯s proprietary technology is available to collaborate or license with all potential partners. Peptron¡¯s preferred research area will be;
¨ç Neurodegenerative Disease including Parkinson¡¯s Disease, MSA, and Alzheimer¡¯s Disease
¨è Type 2 Diabetes and NASH
However, Peptron is looking for any collaboration partners who have proprietary compounds or research programs in all therapeutic fields that may have benefits from Peptron¡¯s SmartDepot¢â technology. Peptron can work together depends on partner¡¯s demands such as formulation development, process development, clinical development process, and even for contract manufacturing when it is commercialized.
Contact us
If you are interested in contacting Peptron regarding partnering opportunities, please email the Business Development Team at biz@peptron.com