Iterum Therapeutics PLC (NASDAQ: ITRM) shares more than doubled on Friday after the firm announced that it had completed the enrollment of its late-stage clinical trial in uncomplicated urinary tract infections (uUTIs).
Specifically, this is the company’s SURE 1 Phase 3 clinical trial of sulopenem for the treatment of uUTIs. This multi-center, double-blind clinical trial is measuring efficacy, tolerability and safety of oral sulopenem/probenecid for the treatment of uUTI in adult women.
Some quick background: there are roughly 13.5 million emergency room and office visits for symptoms of UTIs and about 21 million uUTIs in the United States annually. Based on market research, physicians estimated that 35% of these patients are at elevated risk for treatment failure.
If approved, sulopenem will help address the significant clinical and economic need for new oral antibiotics that enable the avoidance of hospitalization or facilitate early hospital discharge by providing continuity-of-care step-down therapy.
The safety profile for sulopenem had already been documented in the Phase 2 trial of this treatment. So many investors seem to view this Phase 3 trial as smooth sailing, barring any adverse events.
Corey Fishman, CEO of Iterum Therapeutics, said:
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.
Shares of Iterum Therapeutics were last seen up 112% at $5.21, in a 52-week range of $1.68 to $9.30. The consensus price target is $12.00.
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