Pharmaceutical giant Iterum Therapeutics plc, which develops medications for infections caused by multi-drug resistance pathogens, has recently announced its clinical trial for Sulopenem. Sources state that this would mark the first phase of its Phase 3 clinical trials.
For the uninitiated, Sulopenem works well during in-vitro activity to fight organisms commonly concerned with urinary tract and intra-abdominal infections. According to reliable sources, in the trial known as Sulopenem for Resistant Enterobacteriaceae (Sure) 1, the oral sulopenem will be compared to oral ciprofloxacin in women down with uncomplicated urinary tract infections (uUTI).
Sulopenem is Iterum’s lead compound and new antibiotic meant to cure gram-negative and multi-drug resistant infections.
As per a news release by Iterum, patients infected with quinolone resistant pathogen may need secondary antibiotic prescription or hospitalization, if quinolone is prescribed for uncomplicated UTI. Among U. S patients, resistance to fluoroquinolone has been observed in over 20% of isolates from urinary tract caused primarily by resistance to E. coli and P.mirabilis.
The growth of UTIs with multi-drug resistance is disturbing and current drugs fail in treatment, claimed Iterum’s M.D. and Chief Scientific Officer, Michael Dunne. Resistance to fluoroquinolones is rising and healthcare professionals urgently need new oral options to treat infections such as UTIs, he further added.
FDA has warned about the usage of fluoroquinolones for uUTI patients who can be prescribed other drugs as well, as it poses more risks than benefits, stated Dunne.
Approximately 1,364 patients are expected to enroll for the study conducted under an agreement of Special Protocol Assessment (SPA) from the FDA. The trial process will be carried out with patients receiving either oral sulopenem twice for five days or oral ciprofloxacin twice for three days, the ideal uUTI dosage.
Incidentally, Iterum is in talks for initiating two additional Phase 3 clinical trials that will examine the use of oral and intravenous sulopenem in complicated UTIs and complicated intra abominable infections, reported sources familiar with the trials.