Iterum’s patent portfolio also contains pending patent applications outside the U.S., including Europe and China, submitted following receipt of the Written Opinion of the International Search Authority indicating that several claims directed to the composition of the bilayer tablet of oral sulopenem are novel and inventive. Existing patent protection for sulopenem etzadroxil is scheduled to expire in 2029, subject to potential extension. patents are scheduled to expire no earlier than 2039, excluding any additional term for patent adjustments or patent term extensions. 11,554,112 directed to the method of use of oral sulopenem in treating multiple diseases, including uncomplicated urinary tract infections. 11,478,428, directed to the composition of the bilayer tablet of sulopenem etzadroxil and probenecid (“oral sulopenem”) and its related uses, and 2) US Patent No.
Patents Issued: The United States Patent and Trademark Office has issued Iterum two new patents: 1) US Patent No. The SPA agreement provides that the design and planned analysis of the trial, as set out in the protocol submitted to the FDA, adequately addresses the objectives necessary to support the potential resubmission of Iterum’s NDA for oral sulopenem. This trial is being conducted under a SPA agreement with the FDA. An interim analysis at 50% patient enrollment is expected to occur in the second half of 2023. Enrollment is ongoing and expected to be completed in the first half of 2024. Enrollment in REASSURE Clinical Trial Ongoing: Iterum began enrollment in its pivotal Phase 3 clinical trial, REASSURE ( REnewed ASsessment of Sulopenem in u UTI caused by Resistant Enterobacterales), for the treatment of uncomplicated urinary tract infections (“uUTI”) in adult women in October 2022.Food and Drug Administration (“FDA”), is expected to be completed in the first half of 2024.” “Enrollment in our REASSURE trial, which is being conducted under a Special Protocol Assessment (“SPA”) agreement with the U.S. “We made significant progress in 2022 to move the clinical development of oral sulopenem forward leading to a potential resubmission of our new drug application (“NDA”) next year,” said Corey Fishman, Iterum’s Chief Executive Officer. Company to host conference call today at 8:30amET-ĭUBLIN, Ireland and CHICAGO, Ma(GLOBE NEWSWIRE) - Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the fourth quarter and year ended December 31, 2022. Registration Trial for uUTI Ongoing and On Track.
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