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Spero Therapeutics Announces Issuance of Allowance for a U.S. Patent Covering Lead Candidate Tebipenem HBr
CAMBRIDGE, Mass., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today 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. \"This patent issuance by the USPTO is an important milestone in protecting the commercial potential of tebipenem HBr and is a sign of Spero’s innovation while developing the drug as the first oral carbapenem, if approved,\" said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “We remain focused on advancing oral tebipenem HBr towards a potential approval and look forward to submitting the New Drug Application for tebipenem HBr to the FDA in the second half of 2021.” 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. About Tebipenem HBrTebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is Spero’s novel investigational oral formulation of tebipenem pivoxil, a carbapenem antibiotic of the β-lactam class marketed by Meiji Seika Pharma Co. Ltd. (Meiji) in Japan as Orapenem® since 2009 for pediatric infections limited to pneumonia, otitis media and sinusitis. Orapenem® is not approved in the U.S. Carbapenems are an important subclass of antibiotics because they have been observed to be safe and effective in the treatment of drug-resistant Gram-negative bacterial infections. Tebipenem HBr is being developed for the treatment of cUT...