Date: 2017-01-05
Type of
information: Initiation of development program
phase: 3
Announcement: initiation of development program
Company: Iterum Therapeutics (Ireland)
Product: sulopenem
Action
mechanism: antibiotic.
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.
Disease: multi-drug resistant infections
Therapeutic
area: Infectious diseases
Country:
Trial
details:
Latest
news:
- • On January 5, 2017, Iterum Therapeutics announced 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’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 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.
Is
general: Yes
