Spero starts Phase 3 PIVOT-PO trial of tebipenem HBr; $95M milestone payable over two years from GSK

Spero Therapeutics, Inc.

First patient first visit for Phase 3 PIVOT-PO trial (cUTI/AP) targeting ~2,648 patients.
Primary endpoint: overall response (composite of clinical cure + microbiological eradication) at test-of-cure.
Non-inferiority vs IV imipenem cilastatin with 10% NI margin in microbiological ITT population.
GSK license: $95M development milestone payable in 4 equal semiannual installments over 2 years.
Additional milestones: $25M on FDA submission, up to $150M commercial, up to $225M sales, plus tiered royalties.

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