Spero Therapeutics in Special Protocol Assessment Agreement for Phase 3 Trial of Tebipenem HBr
31 Julho 2023 - 9:51AM
Dow Jones News
By Chris Wack
Spero Therapeutics 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 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 also is 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.
Spero shares were up 8% to $1.53 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 31, 2023 08:36 ET (12:36 GMT)
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