Spero Therapeutics shares soared after the clinical-stage biopharmaceutical company announced that it has received special protocol approval from the United States Food and Drug Administration (FDA) for the design and size of its Phase 3 study of its investigational therapeutic tebipenem HBr in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP).
Shares of the Cambridge, Massachusetts-based company, which is focused on developing and commercializing treatments for rare diseases and multi-drug resistant bacterial infections, had added 14.1% at US$1.62 on Monday afternoon.
Spero’s tebipenem HBr is an oral formulation of tebipenem pivoxil, a carbapenem antibiotic of the β-lactam class.
In the PIVOT-PO trial, which was designed in collaboration with GSK, tebipenem HBr will be evaluated against imipenem cilastatin in hospitalized adult patients with cUTI/AP.
The trial is expected to begin in the fourth quarter of 2023.
Spero said that the FDA has indicated that positive and persuasive results from PIVOT-PO, along with previously completed studies, could support the approval of tebipenem HBr as a treatment for cUTI, including AP, for a limited-use indication.
If approved, this would make tebipenem HBr the first oral carbapenem antibiotic for the treatment of cUTI, the company noted.
“With the increasing prevalence of antibiotic-resistant bacteria, cUTI patients often have no choice but to receive an intravenous carbapenem antibiotic in a hospital setting,” Spero’s chief medical officer Dr Kamal Hamed said.
“The goal of our tebipenem HBr program is to provide appropriate patients with an efficacious oral option for the treatment of cUTI. We believe that tebipenem HBr has the potential to deliver strong value to the healthcare system.”
Spero will receive a $30 million development milestone payment from GSK under its licensing agreement. The company noted that it is also eligible to receive further milestone and royalty payments under the terms of the agreement.
This includes up to an additional $120 million in development milestones as the Phase 3 trial progresses; up to $150 million in potential commercial milestones based on first commercial sales; up to $225 million in potential sales-based milestones; and low-single-digit to low-double-digit tiered royalties on net product sales of tebipenem HBr in all territories, except Japan and certain other Asian countries, should sales exceed $1 billion.
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