Iterum Therapeutics Limited Unveils Sulopenem in Development for Treatment of Gram-Negative, Multi-drug Resistant Infections
January 17, 2017 at 08:24 pm
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Iterum Therapeutics Limited reported that its first product candidate, sulopenem, a novel oral penem antibiotic, is under development for the treatment of multi-drug resistant infections. Sulopenem, with a safety and efficacy profile similar to other penems, has demonstrated broad-spectrum coverage and is highly effective against the pathogens most commonly associated with uncomplicated urinary tract infections, complicated urinary tract infections and complicated intra-abdominal infections (uUTI, cUTI and cIAI), including potent in-vitro activity against Enterobacteriaceae (ESBL) mutants of E. coli and K. pneumonia. Sulopenem was licensed from Pfizer in late 2015 and under the license agreement, Pfizer received an initial equity interest and an upfront cash payment from Iterum. Pfizer is also eligible to receive additional equity, development and commercial event-driven cash milestone payments and royalties based upon global net sales of any potential sulopenem products. In the initial indications of interest, it is estimated that there are more than 25 million infections annually in the U.S. alone, with approximately 80% of those occurring in uUTI. Resistance to fluoroquinolones, currently a main treatment in uUTI, has become an issue in many parts of the country and is expected to continue to rise. Additionally, there have been no new treatments approved for uUTI in the last 20 years. Sulopenem's global development efforts to date confirm its safety and efficacy, having been studied in more than 1,100 subjects in Japan with its IV formulation and a Phase 2a oral study in community-acquired pneumonia (CAP) in the U.S. Iterum anticipates commencing three Phase 3 studies under Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA) and Scientific Advice from the European Medicines Agency (EMA) in the initial indications of uUTI, cUTI and cIAI by the end of 2017 and filing a new drug application(NDA) and marketing authorization application (MAA) in the second half of 2019. Separately, the FDA has granted the QIDP designation to sulopenem for its oral and IV formulations for the treatment of uUTI, cUTI and cIAI. The QIDP designation will make sulopenem eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now (GAIN) Act, which include priority review and fast-track status. Further, if approved, sulopenem would be eligible for an additional five-year extension of Hatch-Waxman exclusivity.
Iterum Therapeutics plc is a clinical-stage pharmaceutical company. The Company develops differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. It is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation. Sulopenem is a potent, thiopenem antibiotic delivered intravenously, which is active against bacteria that belong to the group of organisms known as gram-negatives and causes urinary tract and intra-abdominal infections. It has also developed sulopenem in an oral tablet formulation, sulopenem etzadroxil-probenecid. Sulopenem also has an IV formulation. Sulopenem has demonstrated potent in vitro activity against a variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
ITERUM THERAPEUTICS PLC 
