Iterum Therapeutics plc (NASDAQ:ITRM) has announced the submission of a New Drug Application to the US FDA for sulopenem etzadroxil/probenecid. The application is for oral sulopenem in treating uncomplicated urinary tract infections in patients having quinolone non-susceptible pathogen.
Iterum a step closer to delivering penem antibiotic for patients
Corey Fishman, the company’s CEO, said that the NDA submission for oral sulopenem is a significant step forward in delivering new antibiotics to patients. This will help in addressing the problem of antibiotic resistance. He added that if approved, oral sulopenem will give patients and physicians a chance to benefit from approved safe and efficient penem antibiotics currently only available in intravenous formulations. Fishman said that the company is now a step closer to achieving its goal of delivering the much-needed treatment for more than six million patients in the US with Cipro-resistant UTIs annually.
Iterum’s NDA submission includes results from SURE-1, SURE-2, and SURE 3 third phase clinical trials. The data showed a favorable tolerability profile of oral sulopenem without nay considerable drug-linked adverse effects. In the SURE-1 clinical trial, oral sulopenem demonstrated statistical superiority to the commonly used ciprofloxacin for clinical and microbiologic response efficacy endpoint. The response was shown at the test of cure visit for patients having a quinolone non-susceptible pathogen.
Positive FDA feedback on sulopenem studies
In September, the company received positive feedback from the FDA regarding oral sulopenem in treating uUTIs patients with quinolone-resistant pathogens. Iterum is also making preparations for a possible commercial launch of oral sulopenem in the US. Fishman stated that with the possible approval of oral penem in the US, they are delighted to be the first company to market oral penem in the US.
Recently the company presented data from two Phase III studies at the 2020 Infectious Disease Society of America IDWeek™. The data the company presented during IDWeek included a SURE-2 clinical study poster results in complicated urinary tract infections and another oral abstract presentation of data from the SURE-1 clinical study un uncomplicated urinary tract infections.