regulatory
confidence high
sentiment positive
materiality 0.85
FDA agrees to SPA for Spero's Phase 3 tebipenem HBr trial; $30M milestone due from GSK
Spero Therapeutics, Inc.
- FDA granted Special Protocol Assessment (SPA) for pivotal Phase 3 PIVOT-PO trial of oral tebipenem HBr vs IV imipenem in cUTI/acute pyelonephritis.
- Positive results from PIVOT-PO plus prior studies could support FDA approval for a limited use indication.
- Spero to receive $30M development milestone from GSK upon invoicing; additional milestones up to $495M plus tiered royalties.
- PIVOT-PO first patient first visit expected in Q4 2023; trial uses 10% non-inferiority margin per FDA guidance.
- SPR720 Phase 2 enrollment continues; top-line data now expected in H2 2024 (slower than prior guidance).