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Iterum Therapeutics Shares Double After Completing Enrollment in Phase 3 Antibiotic Trial

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Iterum Therapeutics shares traded more than 100% higher after the company reported that it has completed enrollment in its Phase 3 SURE 1 clinical study of oral sulopenem for treatment of uncomplicated urinary tract infections. The firm expects to receive topline data results in Q1/20.

An Ireland-based 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, Iterum Therapeutics Plc (ITRM:NASDAQ), yesterday announced "the completion of patient enrollment in its Sulopenem for Resistant Enterobacteriaceae (SURE) 1 clinical trial in uncomplicated urinary tract infections (uUTI)."

The firm describes sulopenem as "a novel penem anti-infective compound with oral and IV formulations that has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics."

The company indicated that the SURE 1 study is a multi-center, double-blind clinical trial instituted to measure the efficacy, tolerability and safety of oral sulopenem/probenecid for the treatment of uUTI in adult women. Patients in the study are randomized to receive either oral sulopenem/probenecid or oral ciprofloxacin, the current standard of treatment.

Iterum Therapeutics' CEO Corey Fishman commented, "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."

The firm noted that there are about 13.5 million emergency room and office visits for UTI symptoms and around 21 million uUTIs annually in the U.S. The company stated that "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."

Iterum Therapeutics is headquartered in Dublin, Ireland, and is a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives aimed at combating the global crisis of multi-drug resistant pathogens. The company stated that it has received Qualified Infectious Disease Product and Fast Track designations for its oral and IV formulations of sulopenem in seven indications from the FDA.

Iterum Therapeutics began the morning with a market capitalization of about $36.1 million with approximately 14.87 million outstanding shares and a short interest of around 1.90%. ITRM shares opened nearly 12% higher today at $2.72 (+$0.29, +11.93%) over yesterday's $2.43 closing price. Since the open, the firm's stock has risen substantially, trading between $2.72 and $6.47 per share. At present, the shares are trading at $5.53 (+$3.08, +125.71%).

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