other material
confidence high
sentiment positive
materiality 0.70
Xeris reports positive Phase 1 data for SC levothyroxine (XP-8121); weekly dosing matches daily oral
Xeris Biopharma Holdings, Inc.
- Phase 1 study (n=60) shows proof-of-concept for once-weekly SC XP-8121 with steady-state exposure similar to daily oral Synthroid.
- Population PK model implies dose conversion factor of 4X: weekly 1200 μg SC equivalent to daily 300 μg PO levothyroxine.
- XP-8121 well tolerated at all doses (600, 1200, 1500 μg); safety profile comparable to Synthroid 600 μg PO.
- Company expects FDA End-of-Phase 1 meeting feedback by end of 2022.