Tebipenem HBr is being developed as the first oral carbapenem antibiotic for complicated urinary tract infections (cUTI).
Spero expects to start a new phase 3 trial in 2023, following encouraging FDA regulatory feedback on the proposed trial design.
Spero received an FDA Complete Response Letter in June 2022, citing data from Spero’s initial Phase 3 cUTI trial, ADAPT-PO, which were insufficient to support approval.
GSK will receive exclusive rights to the antibiotic in all territories except Japan and certain other Asian countries, which Spero partner, Meiji Seika, will retain.
Spero will be responsible for the execution and costs of the follow-up Phase 3 trial of tebipenem HBr. GSK will be responsible for the execution and costs of additional development, including Phase 3 regulatory filing and commercialization activities.
Spero will receive an upfront payment of $66 million and milestone payments of $225 million.
GSK has also agreed to take an equity stake in Spero, purchasing 7.45 million shares at approximately $1.20805 per share, not to exceed 19.99% ownership of Spero by GSK.
As of June 30, Spero had a cash balance of $45.4 million. The company believes its current cash runway will be sufficient to fund it beyond 2024.
Price Action: SPRO shares are up 154.30% at $2.09 during the premarket session on the last check Thursday.
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