Iterum Therapeutics Announces Topline Results from Phase 3 Clinical Trial of Oral and IV Sulopenem for the Treatment of Complicated Intra-abdominal Infections - Seite 2

In the safety population of 668 patients, treatment related adverse events were observed in 6.0% and 5.1% of patients on sulopenem and ertapenem, respectively, with the most commonly reported drug-related adverse event being diarrhea at 4.5% and 2.4%. Discontinuations were uncommon on both regimens seen in 1.5% of patients on sulopenem and 2.1% of patients on ertapenem. Serious adverse events unrelated to study treatment were seen in 7.5% of patients on sulopenem and 3.6% of patients on ertapenem.

“While the difference in the primary outcome is one patient shy of the target of -10%, imputing an outcome for the patients with missing data and the secondary supporting analyses, both at the end of treatment as well as the test of cure, provide support for the potential of sulopenem in the treatment of multi-drug resistant infections,” said Michael Dunne, MD, Chief Scientific Officer at Iterum Therapeutics. “Over 10% of the patients in this study had a gram-negative pathogen that was resistant to both quinolones and β-lactams, the two classes of oral agents that are most commonly used for step down therapy for this indication. In this era of rapidly emerging multi-drug resistance, we believe the availability of sulopenem in its oral and IV formulations would provide the healthcare system with a much needed option for step-down therapy from hospital to home.”

“We believe that these topline results, while narrowly missing the primary endpoint, provide data that emphasize the potential for sulopenem to help address the growing challenge of antibiotic resistance,” said Corey Fishman, Chief Executive Officer of Iterum Therapeutics.  “If we obtain positive results in Q1 2020 from our Phase 3 complicated and uncomplicated urinary tract trials, we believe that the overall safety and efficacy results from this cIAI trial would be supportive in an FDA filing for oral and IV sulopenem and that sulopenem’s market potential remains robust.”

The multi-center, double-blind SURE 3 randomized patients with cIAI to receive either IV sulopenem once daily for a minimum of five days followed by oral sulopenem/probenecid twice daily to complete 7 to10 total days of treatment, or IV ertapenem once daily for a minimum of five days followed by oral ciprofloxacin twice daily along with oral metronidazole four times daily or, for those patients with ciprofloxacin-resistant organism at baseline, amoxicillin-clavulanate twice daily. The primary endpoint was based on clinical response at Day 28 in patients with a positive intra-abdominal culture at baseline, consistent with recent FDA Guidelines for Development of Drugs for intra-abdominal infections. Clinical outcome at Day 28 was noted as cure for those patients who were alive, had resolution in signs and symptoms of the index infection and for whom no new antibiotics or interventions for treatment failure were required.