Spero Therapeutics Announces Issuance of Allowance for A U.S. Patent Covering Lead Candidate Tebipenem HBr
January 21, 2021 at 06:30 pm IST
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Spero Therapeutics, Inc. announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,889,587, which is directed to a crystalline formulation of tebipenem HBr, Spero’s oral carbapenem in development for the treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis (AP). In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in cUTI and AP. The U.S. Patent No. 10,889,587 covers a crystalline form and pharmaceutical compositions of tebipenem HBr, including the methods of manufacturing and methods of use. The patent expires in February 2038. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP) status by the U.S. Food and Drug Administration (FDA), which provides for an additional five-year extension of Hatch-Waxman Act exclusivity. Tebipenem HBr has also been granted fast track status by the FDA.
Spero Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections with unmet need. Its lead product candidate, SPR720, is an oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Its partnership-directed programs consist of tebipenem HBr and SPR206. The tebipenem HBr is designed to be the oral carbapenem-class antibiotic for use to treat certain bacterial infections that cause complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options. SPR206 is a direct acting intravenous (IV)-administered product candidate being developed as an option to treat MDR Gram-negative bacterial infections in the hospital setting.
SPERO THERAPEUTICS, INC. 
