Spero Therapeutics, Inc. (NASDAQ:SPRO) saw its stock surge by 240% on May 28 following the company's announcement of the successful completion of the pivotal Phase 3 PIVOT-PO trial for tebipenem HBr, an investigational oral antibiotic intended for use in treating complicated urinary tract infections.
The Phase 3 study, conducted in collaboration with development partner GSK plc, effectively achieved its primary goal, proving that tebipenem HBr is not inferior to the intravenous antibiotic imipenem-cilastatin in treating adult hospitalized patients with cUTI. According to a press statement issued by Spero on May 28, tebipenem HBr may be the first oral carbapenem antibiotic that patients in the U.S. can get, potentially addressing an estimated 2.9 million annual cases of cUTIs.
The full trial results will be submitted to a peer-reviewed journal for publication and presentation at a later scientific convention, with Spero and GSK intending to submit the findings to the FDA in the second half of 2025.
https://finviz.com/news/69438/spero-therapeutics-jumps-as-oral-carbapenem-hits-phase-3-milestone
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