Iterum Therapeutics is focused on addressing the urgent global crisis of multi-drug resistant (MDR) bacterial infections through the development of innovative anti-infective therapies. The company's primary product, sulopenem, is a novel antibiotic that is available in both oral and intravenous (IV) formulations. This penem-class antibiotic is designed to effectively combat infections caused by resistant gram-negative pathogens, particularly those responsible for urinary tract infections (UTIs) and intra-abdominal infections (IAIs). By providing a treatment option that can be administered outside of hospital settings, Iterum aims to reduce healthcare costs and minimize the risk of hospital-acquired infections.

The development of sulopenem is notable for its ability to address the limitations of existing antibiotics, particularly in the context of increasing antibiotic resistance. Iterum has successfully revived this previously shelved compound, overcoming various scientific and technical challenges to bring it back into clinical development. The company has conducted extensive pre-clinical and human studies, demonstrating promising safety and efficacy profiles. With Qualified Infectious Disease Product (QIDP) designation from the U.S. FDA for both formulations, Iterum is poised to advance sulopenem through Phase 3 clinical trials, targeting critical indications that reflect the pressing need for effective treatments against MDR infections.

Ireland

Iterum Therapeutics plc, a clinical-stage pharmaceutical company, engages in developing anti-infectives for multi-drug resistant pathogens in Ireland and the United States. It is developing sulopenem, a novel anti-infective compound with oral and IV formulations that is in Phase III clinical trials for the treatment of uncomplicated urinary tract infections, complicated urinary tract infections, and complicated intra-abdominal infections. The company was founded in 2015 and is headquartered in Dublin, Ireland.

Infectious Diseases

Iterum Therapeutics

Urinary tract infection

<p class="font_7">Sulopenem, a novel penem anti-infective compound with oral and IV formulations, has demonstrated potent <em>in vitro</em> activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. 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 of IV sulopenem has been documented in a Phase 2 program. Oral and IV sulopenem are being evaluated in pivotal Phase 3 clinical trials for uncomplicated urinary tract infections, complicated urinary tract infections and complicated intra-abdominal infections.</p>

Iterum Therapeutics

Company Details