Spero Therapeutics Shares Rise 14% After Special Protocol Assessment Agreement With FDA
01 August 2023 - 2:59AM
Dow Jones News
By Chris Wack
Spero Therapeutics shares were up 14% at $1.62 after the company
received written agreement from the U.S. Food and Drug
Administration, under a Special Protocol Assessment, on the design
and size of its pivotal Phase 3 clinical trial of tebipenem HBr in
patients with complicated urinary tract infection, including acute
pyelonephritis.
The stock has more than doubled in the past 12 months.
The biopharmaceutical company designed tebipenem in
collaboration with GSK to provide a clinical path to becoming the
first oral carbapenem antibiotic for treatment of cUTI, if
approved.
The primary efficacy endpoint of the trial will be overall
response at the test-of-cure visit. The FDA has indicated that
positive and persuasive results from the trial, along with
previously completed studies, could be sufficient to support
approval of tebipenem HBr as a treatment for cUTI, including
pyelonephritis, for a limited use indication.
Spero is also eligible to receive milestone/royalty payments
under the terms of its license agreement with GSK, conditional upon
achievement of certain progression of milestones.
Spero could get up to an additional $120 million in development
milestones as the Phase 3 clinical 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 product sales of tebipenem HBr in all territories,
except Japan and certain other Asian countries.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 31, 2023 12:44 ET (16:44 GMT)
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