Iterum Therapeutics (NASDAQ: ITRM) stock plummeted almost 12% on Tuesday following the disclosure of positive topline outcomes from the Phase 3 REASSURE Clinical trial, evaluating oral sulopenem for uncomplicated urinary tract infections.
Iterum Therapeutics (ITRM) has just unveiled promising results from its latest clinical trial, REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) Phase 3. The study focused on comparing the effectiveness of oral sulopenem (a combination of sulopenem etzadroxil with probenecid in a bilayer tablet) against the commonly used oral Augmentin® (amoxicillin/clavulanate) in adult women dealing with uncomplicated urinary tract infections.
Key Findings
The trial’s key finding revealed that oral sulopenem matched Augmentin® in effectiveness, achieving non-inferiority in the primary endpoint, which assessed the overall response (combining clinical cure and microbiologic eradication). This assessment was conducted during the test-of-cure (TOC) visit in the microbiological-modified-intent-to-treat susceptible (m-MITTS) population. Notably, oral sulopenem demonstrated success in 61.7% of patients, surpassing Augmentin® at 55.0%, indicating a statistically significant superiority of oral sulopenem.
Moreover, the study reported high tolerance levels for oral sulopenem and Augmentin®. Adverse events leading to discontinuation were rare, accounting for less than 1% of patients on both treatments. Notably, no serious adverse events (SAE) were linked to oral sulopenem, contrasting with five SAEs in patients receiving Augmentin®—none of which were related to the drug. The safety profile of oral sulopenem mirrored findings from earlier Phase 3 trials, with no new safety concerns emerging beyond those associated with β-lactams.
Iterum expects to share comprehensive findings from the REASSURE trial during an upcoming scientific meeting.
Iterum plans to resubmit the New Drug Application (NDA) for oral sulopenem to the FDA in the second quarter of 2024. Assuming the resubmitted New Drug Application (NDA) effectively rectifies all deficiencies highlighted in the Complete Response Letter (CRL) issued by the FDA in July 2021, Iterum expects that the FDA will conclude its review and make a decision within six months of receiving the resubmitted NDA (or during the fourth quarter of 2024).
Iterum (NASDAQ: ITRM) Stock Price Action
ITRM stock plunged 11.73% on Tuesday. The traders had exchanged hands with 24,416,465 (24.41 million) shares compared to the average daily trading volume of 168.36K.
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