New designations in community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease demonstrate the clinical potential of sulopenem
DUBLIN, Ireland and CHICAGO, March 19, 2019 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens, today announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) to the oral and intravenous (IV) formulations of sulopenem in four new indications, community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease. These new designations augment Iterum’s existing QIDP designations for oral and IV sulopenem for the treatment of uncomplicated urinary tract infection (uUTI), complicated urinary tract infection (cUTI), and complicated intra-abdominal infection (cIAI), which the FDA granted in 2017. The company is currently conducting three pivotal Phase 3 clinical trials in uUTI, cUTI and cIAI, and expects to report top-line results in the second half of 2019.
Fast Track designation for all seven of these indications in both the oral and intravenous formulations has also been granted.
“These additional FDA designations further validate the clinical potential of sulopenem and provide significant additional support for its development. Sulopenem has demonstrated potent in vitro activity against several antibiotic-resistant pathogens for which new treatments are urgently needed,” said Michael Dunne, MD, Chief Scientific Officer of Iterum Therapeutics. “At this time, we remain focused on completing the Phase 3 program of sulopenem in uUTI, cUTI, and cIAI, and look forward to filing new drug applications with the FDA by year-end.”
To achieve QIDP designation, a drug candidate must be intended to treat serious or life-threatening infections, particularly those caused by bacteria and fungi that are resistant to treatment, or that treat qualifying resistant pathogens identified by the FDA. The QIDP designation will make sulopenem eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now (GAIN) Act. Further, if approved, sulopenem would be eligible for an additional five-year extension of Hatch-Waxman exclusivity. Fast-track status provides an opportunity for more frequent meetings with the FDA, more frequent written communication related to the clinical trials, eligibility for Accelerated Approval and Priority Review and the potential for a Rolling Review, which means that the company can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the NDA is completed.
Sulopenem, a novel penem anti-infective compound with oral and IV formulations, has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. If approved, sulopenem will help address the significant clinical and economic need for new oral antibiotics that enable the effective treatment of resistant pathogens in the community, make possible the avoidance of hospitalization, and facilitate early hospital discharge by providing continuity-of-care step-down therapy. The safety profile of IV sulopenem has been documented in a Phase 2 program. Oral and IV sulopenem are being evaluated in three pivotal Phase 3 clinical trials for uncomplicated urinary tract infections, complicated urinary tract infections, and complicated intra-abdominal infections.
About Iterum Therapeutics plc
Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with oral and IV formulations. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit http://www.iterumtx.com.
This press release may contain forward-looking statements. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem. In some cases, forward-looking statements can be identified by words such as “may,” “believes,” “intends,” “seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,” “assumes,” “continues,” “could,” “will,” “future,” “potential” or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Iterum Therapeutics’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside Iterum Therapeutics’ control, including the uncertainties inherent in the initiation and conduct of clinical trials, clinical trial patient enrollment, availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, the actions of third-party clinical research organizations, suppliers and manufacturers, commercialization plans and timelines, if approved, and other factors discussed under the caption “Risk Factors” in its most recently filed Quarterly Report on Form 10-Q, and other documents filed with the SEC from time to time. Forward-looking statements represent Iterum Therapeutics’ beliefs and assumptions only as of the date of this press release. Except as required by law, Iterum Therapeutics assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
Chief Financial Officer
Released March 19, 2019