Iterum Therapeutics plc (NASDAQ: ITRM) shares fell back on Monday after the company reported the completion of enrollment in Phase 3 trial of oral sulopenem in uncomplicated urinary tract infection (UTI).
The company, with headquarters in Chicago and in Dublin, reported last Thursday that the multi-center, double-blind clinical trial is measuring efficacy, tolerability, and safety of oral sulopenem/probenecid for the treatment of uUTI in adult women. Patients are randomized to receive either oral sulopenem/probenecid twice daily for five days of treatment, or oral ciprofloxacin twice daily for three days of treatment.
Said CEO Corey Fishman, "We are pleased to announce the completion of enrollment in our final phase 3 trial for uncomplicated urinary tract infections (uUTI) with over 1,670 patients treated. Topline results from this trial are expected in the first quarter of 2020.
"It has been over 20 years since a new, oral treatment has been developed for urinary tract infections and the existing orals are no longer effective. If approved, oral sulopenem will provide an option to those patients with an elevated risk for treatment failure that currently have no other alternatives."
There are approximately 13.5 million emergency room and office visits for symptoms of UTIs and approximately 21 million UTIs in the United States annually. Based on market research, physicians estimated that approximately 35% of these patients are at elevated risk for treatment failure.
Proper antibiotic treatment of drug-resistant infections in this group is particularly important due to the consequences associated with treatment failure.
Shares lost 81 cents, or 17.1%, to $3.94
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