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Iterum Therapeutics plc (Nasdaq: ITRM) is an Ireland-based clinical-stage pharmaceutical company committed to developing unique anti-infectives to address the global crisis of multi-drug resistant (MDR) pathogens. The company's flagship product, sulopenem, is a novel penem anti-infective available in both oral and intravenous formulations. Sulopenem has shown potent in-vitro activity against a wide range of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics.
Currently, Iterum is focused on advancing sulopenem through Phase 3 clinical development. The company recently completed its REASSURE trial—a critical study comparing oral sulopenem to oral Augmentin® in adult women with uncomplicated urinary tract infections (uUTIs). The trial demonstrated that oral sulopenem was non-inferior to Augmentin® for the primary efficacy endpoint, with statistically significant superiority in overall success rates.
Iterum has also received Qualified Infectious Disease Product (QIDP) and Fast Track designations for sulopenem in seven indications from the U.S. Food and Drug Administration (FDA). The company recently resubmitted its New Drug Application (NDA) for oral sulopenem, which has been accepted by the FDA with a Prescription Drug User Fee Act (PDUFA) action date set for October 25, 2024.
Financially, Iterum reported robust research and development (R&D) expenditures, primarily driven by the REASSURE trial. The company’s net loss decreased in 2023 compared to the previous year, reflecting its focused investment in key clinical trials and strategic projects.
Iterum is actively seeking partnerships and strategic options to maximize the value of sulopenem, including potential sales or licensing agreements. The firm's dedicated efforts in combating MDR pathogens aim to significantly improve the lives of people affected by serious and life-threatening diseases.
Dublin, Ireland and Chicago, April 20, 2023 – Iterum Therapeutics (Nasdaq: ITRM) announced the presentation of two posters at the 33rd Annual European Congress of Clinical Microbiology and Infectious Disease (ECCMID) in Copenhagen on April 17, 2023. The presentations focused on a novel analysis method called Desirability of Outcome Ranking (DOOR) applied to Phase 3 trials of their antibiotic sulopenem for uncomplicated (uUTI) and complicated urinary tract infections (cUTI). Key findings demonstrated that oral sulopenem was more effective than ciprofloxacin for uUTI and comparable to ertapenem for cUTI. This approach, though not yet a primary endpoint for regulatory approval, reflects a commitment to evaluating patient outcomes comprehensively. Iterum is advancing sulopenem, an innovative treatment for multi-drug resistant infections, with QIDP and Fast Track designations for multiple indications.
Iterum Therapeutics (Nasdaq: ITRM) reported its financial results for Q4 and full year 2022, showing a net loss of $5.1 million for Q4 and $44.4 million for the entire year, improving from a net loss of $4.2 million and $91.6 million in 2021. The company focuses on developing oral and IV antibiotics to combat multi-drug resistant infections. Enrollment in the REASSURE clinical trial for uUTI treatment is ongoing, with an interim analysis expected later in 2023. Cash reserves as of December 31, 2022, stand at $60.8 million, projected to sustain operations until mid-2024. The company also received two new patents extending its portfolio until at least 2039.
Iterum Therapeutics, a clinical-stage pharmaceutical company, will announce its Q4 and full-year 2022 financial results before the U.S. markets open on March 16, 2023. Management will host a conference call at 8:30 a.m. ET to discuss the results and provide a business update. Sulopenem, Iterum's lead compound, is in Phase 3 clinical development and has received QIDP and Fast Track designations for multiple indications. Investors can access the call via dial-in or audio webcast through the company's website.
Iterum Therapeutics plc (Nasdaq: ITRM) announced a Notice of Allowance from the USPTO for its patent on the combination of sulopenem etzadroxil and probenecid, aimed at treating uncomplicated urinary tract infections.
This new patent, set to expire in April 2039, strengthens Iterum's position in the market for oral antibiotics, following a recently issued patent covering the bilayer tablet formulation. The company is currently enrolling patients in a Phase 3 clinical trial for oral sulopenem and anticipates updates after reaching 50% enrollment.
Iterum Therapeutics plc (Nasdaq: ITRM) announced its third-quarter financial results for 2022, reporting a net loss of $29.1 million compared to a net income of $3.7 million in 2021. The company initiated the REASSURE clinical trial for oral sulopenem, targeting uncomplicated urinary tract infections, with enrollment expected to conclude by mid-2024. Iterum's cash position stands at $64.3 million, projected to sustain operations into 2024. A new patent for oral sulopenem was issued, extending protection until 2039. The company also regained compliance with NASDAQ's minimum bid price requirement following a reverse stock split.
Iterum Therapeutics plc (Nasdaq: ITRM) announced that it will release its third quarter 2022 financial results on November 10, 2022, before U.S. market opening. A conference call will follow at 8:30 a.m. ET for discussing these results and business updates. The Company is progressing its lead product, sulopenem, a novel anti-infective in Phase 3 clinical development, demonstrating effectiveness against multi-drug resistant pathogens. Iterum has secured QIDP and Fast Track designations for sulopenem across seven indications.
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