PS1 Update: US FDA IND Submitted for Phase 2 Type 1 Diabetes Trial

Full announcement: [https://mops.twse.com.tw/mops/#/web/t146sb05?companyId=7878 ]

PHARMASAGA Limited Company (Taiwan Emerging Stock Market: 7878) announced on October 9 that it has completed the submission of an IND application to the US FDA for PS1-I-201, a Phase 2 clinical trial of PS1 in type 1 diabetes. The company has completed its Phase 1 trial.

PS1 is a first-in-class, small-molecule PDIA4 inhibitor, with a mechanism centered on preserving pancreatic islet cells.

For teams working in metabolic and autoimmune disease: what do you see as the most important considerations when moving a program from Phase 1 to Phase 2?