Iterum Therapeutics plc (NASDAQ:ITRM) has announced that following discussions with the FDA at a pre-NDA meeting; the company will proceed with a New Drug Application submission for sulopenem etzadroxil/probenecid. The company is expecting to submit the NDA in the coming quarter.
Iterum to file NDA for Sulopenem
Sulopenem is a bilayer tablet from the company for treating uncomplicated urinary tract infections for patients who have a quinolone-resistant pathogen. Corey Fishman, the company’s CEO, said that they are delighted with the promising discussions they had with the FDA. Fishman said that they now believe that they have a solid understanding of the FDA’s requirements to guide the NDA submission as well as the goal of the review. He added that as per the feedback from the pre-NDA meeting and previous correspondence, the company now has confidence with its decision to proceed with NDA submission for sulopenem etzadroxil/probenecid in treating uncomplicated urinary tract infection patients with quinolone-resistance pathogens.
Fishman said that they estimate more than 6 million quinolone-resistant UTIs per year in the US. Most of these infections are multi-drug resistant, but sulopenem has shown superiority against ciprofloxacin in treating UTIs.
Sulopenem study results showed an ORR of 62.5%
In June, Iterum released topline results from the Phase 3 SURE 1 study evaluating sulopenem in treating uncomplicated urinary tract infections. Results showed that sulopenem achieved one primary endpoint despite missing a related endpoint. The oral response rate for sulopenem was 62.5% compared to 36% in the population that received ciprofloxacin.
The company is advancing differentiated anti-infective for combating multi-drug resistant pathogens to improve individuals’ lives with life-threatening and serious diseases. Sulopenem is the company’s first novel penem anti-infective compound that is in phase 3 clinical development with IV and oral formulation. Sulopenem has shown potency in vitro activity against a range of gram-positive, gram-negative, and anaerobic bacteria resistant as well as antibiotics. The company has received Fast Track and Qualified Infectious Disease Product for its IV and oral sulopenem formulations in seven indications.