Spero Therapeutics has obtained written agreement from the U.S. Food and Drug Administration (FDA) for a Special Protocol Assessment, which outlines the design and size of its pivotal Phase 3 clinical trial. This trial will evaluate the efficacy of tebipenem HBr in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis.
In collaboration with GSK, Spero Therapeutics has developed tebipenem, aiming to introduce the first oral carbapenem antibiotic for the treatment of cUTI, subject to FDA approval.
The primary efficacy endpoint of this trial will be the overall response observed during the test-of-cure visit. The FDA has indicated that positive and compelling results from this trial, combined with previously conducted studies, may be sufficient to support the approval of tebipenem HBr as a treatment for cUTI, including pyelonephritis, with a limited use indication.
As part of its license agreement with GSK, Spero Therapeutics is eligible to receive milestone and royalty payments upon achieving certain development milestones. During the progression of the Phase 3 clinical trial, Spero Therapeutics could potentially receive up to $120 million in development milestones. Additional potential milestone payments include up to $150 million based on first commercial sales and up to $225 million based on sales performance. Furthermore, Spero Therapeutics will receive tiered royalties in the low-single digit to low-double digit range on tebipenem HBr sales worldwide, excluding Japan and certain Asian countries.
In premarket trading, Spero shares experienced an 8% increase, reaching $1.53.